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CONTEMPOR ARY OB/GYN JUNE 2016, Vol. 61, No. 06 JUNE 2016 VOL. 61 NO. 06 Expert Advice for Today’s Ob/Gyn For Doctors by Doctors ContemporaryOBGYN.net MATERNAL OBESITY MATERNAL OBESIT Y AND THE FETAL BR AIN ◾ SCANZONI MANEUVER ◾ ACOG GUIDELINES ◾ MACR A AND THE OB/GYN FAT AND THE FETAL BRAIN TOLAC in the morbidly obese Rodney K Edwards, MD, MS PAGE 24 Andrea G Edlow, MD, MSc, and Larissa H Mattei, BA FIRST PERSON Scanzoni step by step PAGE 37 PRACTICE MATTERS Lessons from Lean and Six Sigma PAGE 28 ACOG GUIDELINES Operative vaginal delivery PAGE 34 CONTEMPOR ARY OB/GYN JUNE 2016, Vol. 61, No. 06 JUNE 2016 VOL. 61 NO. 06 Expert Advice for Today’s Ob/Gyn For Doctors by Doctors ContemporaryOBGYN.net MATERNAL OBESIT Y AND THE FETAL BR AIN ◾ SCANZONI MANEUVER ◾ ACOG GUIDELINES ◾ MACR A AND THE OB/GYN MATERNAL OBESITY FAT AND THE FETAL BRAIN TOLAC in the morbidly obese Rodney K Edwards, MD, MS PAGE 24 Andrea G Edlow, MD, MSc, and Larissa H Mattei, BA Could embryo adoption or donation be the right choice for your patients? FIRST PERSON Scanzoni step by step PAGE 37 PRACTICE MATTERS Give them each option and every hope! Lessons from Lean and Six Sigma PAGE 28 ACOG GUIDELINES 970-663-6799 www.Snowflakes.org | [email protected] Operative vaginal delivery PAGE 34 If your patients are struggling with infertility or are unsure of what to do with their remaining embryos, inform them about Snowflakes Embryo Adoption and Donation. Over 6,000 babies have been born as a result of embryo adoption & donation. • Through embryo adoption, patients are able to give birth to their adopted child. • You can help patients avoid the high cost of donor eggs with embryo adoption. • Do your patients know about embryo donation? Help them better understand their embryo disposition choices. Contact us to learn more. 970-663-6799 www.Snowflakes.org | [email protected] THE THINPREP SYSTEM The first FDA-approved liquid-based Pap test that is significantly more effective than conventional.1* The first FDA approval of glandular disease labeling.1 The first FDA approval for an automated imager, the ThinPrep Imaging System. The first and only FDA-approved collection media for use with all FDA-approved HPV tests. off patie tie tie entt po opul opu pu a p atio tio t ons. n ns ssol soli ol cita citta ation on or o prom pro romotio motio ot on wh ot oti w ere ere such succh ac act activit activit vitties vi vit ie ies es ar e are rre e proh pro p rohibit ibi ib b e bit bi ed. ed d.. Beca d ecause usse Holo use Hologic olog gicc mate aterrial a ria ia a s ar a e di d stri str tr bute bu ed th but t roug rou ough websit oug websit we bsssitiitte ess, eBr es, eB e Bro oad oadc adc dca asts sts tss and a an tra tr de tr desh des esh e how ows ows, wss itt iss not w ot a alway lway way w ays po p possib ssssib ssib ib ble e to cco ont ntro ntrol ntr r l wh wher ere e re r ssuch uch u h mat ma eria ma rialss a rials appea pp ppea pea pe e r.r For Fo orr sspeci peci pec ecific c fic fic in nfo nf nfor orrmati o m on mat ma on o on n wh what produ odu du ucts ts are avai ava vaiilab labl abl ble for for sale s le sa e in a part particul icccu icu icul cular ar count co ou oun ount un ntrry, ryyy, plea ple lea ea e asse e con ontacctt your onta ou u loca loc oca ccal Ho Hologi og c re og ogi rep pre pr pres re res esen enta enta ent tative ttive ivv or ive or writ wri ritte tto o dia diagnost diag ia no iag nost nos nost sstiic. ic.s ic c solut olut lutions ution iions ons on o ns.com n com com m. We proudly celebrate the 20th Anniversary of the ThinPrep® Pap test. When the ThinPrep Pap test was introduced in 1996, all Pap testing was done via conventional “Pap smears,” and HPV testing was not a part of the cervical cancer screening algorithm. Since then, there has been a significant reduction in invasive cervical cancer in the U.S.2 That’s something to celebrate. Today, more than 650 million ThinPrep Pap tests have been performed, with more than 6,000 ThinPrep processors installed globally.3 The ThinPrep family has been a leader in cervical cancer screening, and it has remained the trusted choice in Pap testing for the large majority of top healthcare providers and laboratories across the U.S.3,4 Today, Pap+HPV Together™ (cotesting) is supported as the best strategy for detecting high-grade cervicovaginal lesions in women ages 30-65, according to recent studies.5,6 Guidelines also recommend the use of co-testing as the preferred screening choice for women ages 30-65.7 Hologic continues to stand behind this testing modality as the best screening strategy for women. While we celebrate our past, we continue to look to the future. The ThinPrep Pap test is the most trusted and widely used Pap test on the market. With your partnership, we have contributed to a decline in cervical cancer rates. We’re looking forward to delivering you innovative tools and advancing cervical cancer screening together for the next 20 years and beyond. Ref Refe R eferenc eren rrenc enc nces: nc ess: s 1. 1 Thi Th Th nPre nP Pre P re ep 2 20 0 000 00 0 0 Sys yyste s em m [[packa ack ck k g ge e inser n t] ns nse t] M t]. MAN MANAN N 02060-00 0206 206 06 60-00 0-00 0-0 000 02 Re R v. 001 001. 0 Mar 01 Marl Marlboro ar boro bor ugh, ugh gh MA: MA MA Ho Hol Ho ogic og c,, In ogi nc.; c..; 2011 20 201 011. 2. 011. 2. Nat Nat Nationa ation iiona ona o na all Can Canc C anc an n e err Inst nsti n ns sstit tute tu tut ute u e.. SE S SEER EER R Sta ttat at at Fact Factt She Fac Sh S heets: ets e et ts: Cer C vvix ixx Uter Uter Ute e i Ca Cancer. ncer n nce cer e. h htttp:/ :///see /sse eerr.ca cancer cancer ncer.gov nce .gov gov/sta gov /stt tfac /sta /s tfacts/h fa acts/html ts/h s/h /h html/ tm m cerv cer ervix.html. ix.h x.h html tml. ml.. Acccesse m sse ed Ap A ril rilil 28, ri 28 8, 201 2016 016 0 16. 3.. Hol 3 Hologic Ho ogi ogic og gic g ic, In ncc.. Data ata ao on n File ile. le le. e. 4. 4. U U.S. U.S .S S New New ws & Wor Worl W Wo or d Re Report po por port orr . Be Best esst Hospi osp tal tals alss for fo Adult Adu dultt Gynec ynecolog ology. olog logy. y. http: tttp: p://health //h // //he /he /h h alth th.usn th usnews. usn ews ews. wss com/ com om/ om m/best bes -hos be best -ho ho hos hospita o p pittals pita lss/ ls/ rank ra ankiings ing ngs gss/gy g /gyn gyn yneco ecol col co ology. ogy o ogy. og gyy. Pu g Publish Pub lish ish ssh hed 2016. 016 116. 6. Acc 6 Accesse ce esse ess esse sed Ap A ril ril 28, 28 2 28 2016 0 . 5. 5 B Blatt tt,t, ett al. all.. Compa ompariso omp riso son n of o Cer Ce vvica ica cal al Ca C n ncer ce er S Sc een Scr een ngRe ee eeni gRe gR Re esult ssul ults Amon Amo Amon Among m ng 25 256, 6,64 6,64 6 648 Women W Wo omen e iin en nM Multi ultiple ul ult ulti ple Cl Cl nical Cli Clin ical ica ical ic ca Pra ca Praccti cttic ctic i es. e Cancer es Can Canc an err Cytopatho ytop topatho h l. 20 2015;1 15 15;1 5;123(5 23(5 3(5 5):2 ):28 :28 282-8. 28 2--8 2-8 8 doi do o :10 :10. 10 0 1100 10 1002 002 02/c /cnc /cn c yy.21 2 2154 544 5 544. 44. 6 4 6.. Zha Zhao Zh o, et alll. C al. a Cllin Clin l nica ical cal al Per Pe P errform orma ormance ance anc nce nc cce of of th the he e Foo Food ood and and Drug an Dru Dr D ug Ad Admini miiinisstra min sttr tra ation tio ttion on-App -Ap App p rove ove oved v d High-R H gh-R Hi gh ghh Risk sk kH HP HPV PV Tes PV Te T Test e for fo or the Det Detect ecti ct on of Hi H gh-G ghh-G - rade ade ade e Cerv Cerv Cervicov Cer Ce r icov iccov covag agin agin nall Lesio esions esi es nss [p n pub pu publ ublishe u sshe h hed on o line line in n ahe ahead of ah of print p int pr in ntt Janu n January Jan anuary ryy 15, 1 2016 15 2 ].]. Ca Canc anccer C Cytop ytop t patho to ath tho h l. doi:10 i:10 10 0.10 .1.100 100 100 02/cn 2/cn 2/c /cc ccy.2 cyyy.2 .2 21687 168 687 68 87. 87. 7. ACO 7. A ACOG. ACOG G.. Ce erv ervi rvv ca call C Can Canc anc ncer e Scree er r ning an and a nd Pre P event ven ion. vent ion n Obst Obstet et Gynec Gynec y ol.. 20 ol 2016;1 16 16; 6 27:e 27:e1-20 7:e1-20 1-2 20. 20 0. do doii:10 :10 10.109 10 109 097/AOG.00 0 7/AO 7/A AOG.000000 A G.00 G 0000000000 0000 000 00 000000 000 0 0012 0 256 012 56 56. Learn why the world trusts the ThinPrep system at ThinPrep.com EDITORIAL BOARD HAVE A QUESTION FOR THE BOARD? SEND IT TO US AT EDITOR IN CHIEF [email protected] DEPUTY EDITOR CHARLES J LOCKWOOD, MD, MHCM JON I EINARSSON, MD, PHD, MPH Senior Vice President, USF Health Dean, Morsani College of Medicine Associate Professor of Obstetrics and Gynecology Harvard Medical School University of South Florida Brigham and Women’s Hospital Director, Division of Minimally Invasive Gynecologic Surgery TAMPA, FL BOSTON, MA YOUR EDITORIAL BOARD PAULA J ADAMS HILLARD, MD JOHN O DELANCEY, MD CHRISTIAN PETTKER, MD Professor, Department of Obstetrics and Gynecology, Chief, Division of Gynecologic Specialties Norman F Miller Professor of Gynecology, Director, Pelvic Floor Research, Group Director, Fellowship in Female Pelvic Medicine and Reconstructive Surgery Associate Professor, MaternalFetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences Stanford University School of Medicine STANFORD, CA University of Michigan Medical School HAYWOOD L BROWN, MD ANN ARBOR, MI F. Bayard Carter Professor and SARAH J KILPATRICK, MD, PHD Chair, Obstetrics and Gynecology Duke University Medical Center Helping Hand Endowed Chair, Department of Obstetrics and Gynecology DURHAM, NC ILANA CASS, MD Cedars-Sinai Medical Center Vice Chair, Associate Clinical Professor, Department of Obstetrics and Gynecology LOS ANGELES, CA STEVEN J ORY, MD Cedars-Sinai Medical Center Professor of Obstetrics and Gynecology LOS ANGELES, CA Yale School of Medicine NEW HAVEN, CT SHARON T PHELAN, MD Professor, Department of Obstetrics and Gynecology University of New Mexico ALBUQUERQUE, NM JOE LEIGH SIMPSON, MD Executive Associate Dean for Academic Affairs, Professor of Obstetrics and Gynecology, and Human and Molecular Genetics JOSHUA A COPEL, MD Florida International University Florida International University College of Medicine Professor, Obstetrics, Gynecology, and Reproductive Sciences, and Pediatrics MIAMI, FL MIAMI, FL Partner IVF Florida Yale School of Medicine MARGATE, FL NEW HAVEN, CT FOUNDING JOHN T QUEENAN, MD EDITOR Professor and Chair Emeritus, Department of Obstetrics and Gynecology Reprint Services 877-652-5295 ext. 121 [email protected] Georgetown University School of Medicine WASHINGTON, DC Outside US, UK, direct dial: 281-419-5725. Ext. 121 CONTENT Miranda Hester Ken Sylvia Joanna Shippoli Sara Michael Content Specialist VP Group Publisher VP, Content & Strategy Nancy Bitteker Aviva Belsky Account Manager, Recruitment Advertising 440-891-2615, [email protected] Teresa McNulty Director, Design and Digital Production Group Content Director Nicole Davis-Slocum Group Publisher 732-346-3044, [email protected] Judith Orvos Art Director Alison O’Connor Editorial Consultant SALES & MARKETING Associate Publisher 732-346-3075, [email protected] Susan C Olmstead Georgiann DeCenzo Renee Schuster List Account Executive 440-891-2613, [email protected] Maureen Cannon Permissions/International Licensing 440-891-2742, [email protected] Content Channel Director Executive Vice President, 440-891-2704, [email protected] Managing Director 2 CONTEMPOR ARYOBGYN.NE T JUNE 2016 CANCER RISK AND SCREENING LabCorp and Integrated Genetics, a member of LabCorp’s Specialty Testing Group, take a personal approach to laboratory testing by offering a comprehensive test portfolio for breast, ovarian, and cervical cancer. Our test options—combined with an extensive network of genetic counselors—provide you and your patients with information needed about their health. We take a personal approach to laboratory testing. BRCAssureSM– BRCA 1 and 2 analysis for hereditary breast and ovarian cancer Patients with BRCA mutations are at increased risk for breast, ovarian, and other cancers. Knowing your patients’ BRCA mutation status may assist in the development of tailored prevention or treatment strategies. LabCorp offers a suite of BRCAssure tests to meet your patients’ needs. Age-based test protocol for cervical cancer and STD screening Age-based approach for HPV, Pap, and Ct/Ng provides an additional tool to help physicians manage their patients according to a patient’s age. LabCorp based its test protocol on the American College of Obstetricians and Gynecologists' guidelines.1,2 ROMA® - Risk of Ovarian Malignancy Algorithm For women who present with a pelvic mass, ROMA combines the ARCHITECT® CA 125 IITM and Fujirebio Diagnostics HE4 with menopausal status to help physicians assess risk stratification of women over age 18 for whom surgery is planned, helping to predict ovarian cancer in women with a pelvic mass. To learn more about the test options, visit www.LabCorp.com. 1. American College of Obstetricians and Gynecologists. Screening for Cervical Cancer. ACOG Practice Bulletin N° 131, November 2012. Obstet Gynecol. 2012 Nov; 120(5):1222-1238. 2. American College of Obstetricians and Gynecologists. Primary and Preventive Care: Periodic Assessments. ACOG Committee Opinion N° 483, April 2011. Obstet Gynecol. 2011 Apr; 117(4):1008-1015. ©2015 Laboratory Corporation of America® Holdings All rights reserved. 13525-0115#2 ROMA is a registered trademark, and CA 125 II is a trademark, of Fujirebio Diagnostics, Inc., Malvern, Pa. ARCHITECT is a registered trademark of Abbott Laboratories. PRECAUTION: ROMA should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA (HE4 EIA + ARCHITECT® CA 125 II ) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. TM IN THIS ISSUE june 2016 VOLUME 61 | NUMBER 06 PEER-REVIEWED Maternal obesity and the fetal brain 24 ANDREA G EDLOW, MD, MSC, AND LARISSA H MATTEI, BA RODNEY K EDWARDS, MD, MS In certain subsets, planned cesarean delivery is the safest route. A look at how obesity in the mother affects a fetus’s neurodevelopment. 28 PRACTICE MATTERS Lean and six sigma for your practice 34 THOMAS LEE, MD, MBA The concepts of Lean and Six Sigma can be used by clinicians on the front lines to begin to change how their practices operate. 06 10 DR. LOCKWOOD’S TAKE ACOG GUIDELINES The lost art of operative vaginal delivery Editor in chief Charles J Lockwood, MD, MHCM, provides commentary on ACOG Practice Bulletin No. 154: Operative Vaginal Delivery. 48 LEGALLY SPEAKING CHARLES J LOCKWOOD, MD, MHCM ANDREW I KAPLAN, ESQ Even if you see few Medicare patients, you’ll need to start preparing for value-focused payment. Did induction cause this uterine rupture? 44 CAREERS/ADVERTISER INDEX READERS REACT Should some morbidly obese women forgo labor? 36 FIRST PERSON The Scanzoni maneuver: get a handle on it SARAH CIGNA, MD, MS, NANCY D GABA, MD, AND JOHN W LARSEN JR, MD An illustrated step-by-step guide to performing this underused forceps turn. OUR MISSION For nearly a half century, busy practitioners have trusted Contemporary OB/GYN to translate the latest research into outstanding patient care. We are dedicated to providing them with evidence-based information on scientific advances in a clinically useful format. DON’T FORGET TO CHECK OUT OUR APP FOR APPLE AND ANDROID DEVICES! Let us know what you think. Email us at [email protected] CONTEMPORARY OB/GYN (Print ISSN#0090-3159, DIGITAL ISSN#2150-6264), is published monthly by UBM Medica 131 West First St, Duluth, MN 55806-2065. One-year subscription rates: $110.00 per year (USA and Possessions); $140.00 per year (elsewhere). Single copies (prepaid only) $12.00 in the USA; $18.00 per copy elsewhere. Include $6.50 per order plus $2.00 for US postage and handling. Periodicals postage paid at Duluth, MN 55806 and additional mailing offices. POSTMASTER: Please send address changes to Contemporary OB/GYN, PO Box 6084, Duluth, MN 55806-6084. Return Undeliverable Canadian Addresses to: IMEX Global Solutions, PO Box 25542, London, ON N6C 6B2, CANADA. Canadian GST number: R-124213133RT001. Publications Mail Agreement Number 40612608. Printed in USA. Subscription inquiries/address changes: toll-free 888-527-7008, or dial direct 218-740-6477. © 2016 UBM. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/ educational or personal use of specific clients is granted by UBM for libraries and other users registered with the Copyright 4 CONTEMPOR ARYOBGYN.NE T Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright. com online. For uses beyond those listed above, please direct your written request to Permission Dept. fax 440-756-5255 or email: [email protected]. UBM Medica provides certain customer contact data (such as customers’ names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want UBM Medica to make your contact information available to third parties for marketing purposes, simply call toll-free 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer service representative will assist you in removing your name from UBM Medica’s lists. Outside the U.S., please phone 218-740-6477. CONTEMPORARY OB/GYN does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477. JUNE 2016 ILLUSTRATION BY ALEX BAKER, DNA ILLUSTRATIONS, INC. 16 With over 2 million successful GEA procedures, it’s been said: “The NovaSure system worked beautifully.” ® Predictable outcomes for millions of patients. Plus training, service, and support—the comprehensive standard of care that’s second to none. We’re proud to be your partner for 14 years and counting. ADS-01324-001 Rev. 002B ©2016 Hologic, Inc. Hologic, NovaSure and The Science of Sure are trademarks or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. DR LOCKWOOD’S TAKE by CHARLES J LOCKWOOD, MD, MHCM MACRA primer for ob/gyns Even if you see few Medicare patients, start preparing for value-focused payment. B ack in 1997, when healthcare consumed 13.2% of the GDP, there were dire warnings about the unsustainable costs of Medicare. In response, Congress enacted the Balanced Budget Act, which contained a provision termed the Sustainable Growth Rate (SGR). The SGR formula was designed as a politically risk-free mechanism for legislators to limit Medicare spending. The idea was that if physician costs exceeded targets, an across-the-board reduction in Medicare payments to physicians would be automatically triggered unless actively overruled by Congress. Thus began an annual kabuki dance in which physicians were threatened with outlandish cumulative cuts in their Medicare payments—often over 20%, due to outof-control costs. However, magically at the 11th hour, we were habitually “saved” and grateful to receive some de minumus increase. Worse, this exercise in futility did nothing to restrain healthcare costs. In 2014, US healthcare spending grew at 5.3%, totaling more than $3 trillion or $9523 per person and accounting for 17.5% of GDP.1 Well, the good news is that in April 2015, Congress repealed the SGR. The bad news is that it was replaced by a potentially more onerous 6 CONTEMPOR ARYOBGYN.NE T Maternal obesity and the fetal brain A look at how obesity in the mother affects a fetus’s neurodevelopment. Read more on page 16. MY MUST READS Morbidly obese gravidas: Labor or not? In certain subsets, planned cesarean delivery is the safest route.. Read more on page 24. and very complex piece of legislation: the Medicare Access and CHIP Reauthorization Act, or MACRA for short. What is MACRA? While MACRA ends the hated SGR formula, its leitmotif is the generation of accelerating financial pressure and administrative burdens designed to drive physicians from their comfort zone of traditional fee-for-service payments to either partially at-risk value-based payments (VBPs) or more fully at-risk (ie, capitated) advanced alternative payment models. Fundamentally, MACRA is designed to slow annual Medicare spending increases, which currently run at a 5.5% compound annual growth rate and account for 20% of total national health expenditures.1 It also is designed to unify the current patchwork of Medicare physician VBP programs including the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier and, perhaps most hated, the Electronic Health Record Meaningful Use Incentive Program. Finally, it should be noted that the enabling legislation passed overwhelmingly with strong bipartisan support, so it is unlikely to go away regardless of which party wins our increasingly bizarre presidential “reality show” contest or whether the Accountable Care Act endures beyond January 2017. So I would advise you to read on. How will MACRA work? While its final rules may change, at its core, MACRA streamlines current VBP programs into 2 distinct pathways: 1. the Merit-Based Incentive Payment System (MIPS), an incremental strategy linking physician reimbursement to both increases in the quality (ie, patient safety and outcomes) and reductions in cost of care, but retains a fee-for-service payment structure; and 2. the Advanced Alternative Payment Model (APM), which builds on current accountable care organizations, bundled payments, and patient-centered medical homes to encourage partial or fully capitated care administered through large, clinically integrated provider networks. All physicians caring for JUNE 2016 MACRA TABLE MIPS performance categories Clinical Variable Weight in year one Clinical prac- 15% tice improvement activities Methodology This is simply a measure of continuous quality improvement efforts and will require tracking safety parameters and/or outcomes in response to interventions. Physicians will be able to select activities that match practice patterns and goals from a list of over 90 options. Advancing care informatics (EHR meaningful use) 25% This set of variables will parallel current meaningful use provisions (eg, electronic prescribing, provider order entry, patient portal use, patient data safeguards, disease registries, etc.) with the ability of SK\VLFLDQVWRFXVWRPL]HPHDVXUHVWKDWUHÁHFWWKHLU day to day practice but with an emphasis on interoperability and information exchange. Quality of care 30% These mostly process of care metrics will be modHOHGDIWHU3456HJXVHRIÁXDQGSQHXPRQLDYDFcines, cancer screening tests, medication reconciliation, appropriate management of heart disease). Physicians will be able to report 6 measures from a UDQJHRIVSHFLDOW\DQGSUDFWLFHVSHFLÀFRSWLRQV Cost (resource utilization) 10% This is a comparison of the cost of your care for Medicare patients compared to national peers. This category will be based on Medicare claims for 40 HSLVRGHVSHFLÀFPHDVXUHVWRDFFRXQWIRUGLIIHUHQW specialties. On the bright side there would be no reporting requirements for doctors (but on the other hand you will have to rely on the accuracy of our federal government). Source: US Department of Health & Human Services2 Medicare patients will have to choose one of these 2 paths well before 2019. Merit-Based Incentive Payment System (MIPS) I believe that the majority of physicians are likely to initially choose the MIPS path as it is essentially an aggregation of 3 different programs about which many physicians have JUNE 2016 some knowledge and/or already participate. On an annual basis, physicians will submit process and outcome measures, proof of quality assurance efforts and electronic health record (EHR) adoption data to the Centers for Medicare and Medicaid Services (CMS) which will, in turn, assess all related Medicare claims to determine DR LOCKWOOD’S TAKE the total costs of a physician’s care. CMS will use a weighted composite score to compare all physicians, which will determine whether a bonus or penalty is due (Table). The mean composite score for all MIPS-eligible physicians will be calculated for the prior performance period. Payment adjustments will be based on a sliding-scale bell-shaped curve such that physicians who score at the threshold will receive no payment adjustment, those above the mean will receive a positive adjustment on each Medicare Part B claim for the following year, and those below the mean will receive a negative adjustment the following year.3 The delta in payments will increase from ±4% in 2019 to ±9% in 2022. However, the expectation is that so many participants will be penalized or not receive bonuses that, in order to remain revenue neutral, higher bonuses can be provided to exceptionally highquality providers—up to 27% by 2025. Finally, it is expected that the weighting of measures will change over time and that the composite mean will also frequently change based on continuous improvements by all participants. The baseline MIPS physician fee schedule will increase annually by 0.5% from 2015 through 2019 with no increases from 2020 through 2025 and a minimal 0.25% annual increase at and after 2026. But don’t despair, there are likely to be physician exemptions from MIPS, including those in their first year of practice, those working in rural or Federally Qualified Health Clinics and, obviously, those participating in advanced APMs.3 In addition, physicians with very low Medicare volumes may also be exempted, an exception that may CONTEMPOR ARY OB/GYN 7 DR LOCKWOOD’S TAKE be particularly relevant to ob/gyns. Advanced Alternative Payment Model (APM) Given the relatively flat and at-risk fee schedules inherent in MIPS, you may be interested in how the alternative pathway works. The advanced APM path is designed for physician groups that are already accepting some form of risk in their payments (eg, Accountable Care Organizations [ACOs] or bundled payments). While only about 30% of Medicare payments are currently funneled through advanced APMs,4 CMS has clearly indicated its intent is to move more and more physicians in this direction. Providers opting to pursue the MACRA schedule growth rate will be substantially higher for qualifying advanced APM participants than for MIPS providers (0.75% vs 0.25%). However, there is always a potential to lose money by taking risk and then not providing the requisite value (ie, having low quality and/or high cost). Yet to be determined is how CMS will manage “collisions” of alternative payment models.4 For example, groups of primary care physicians participating in a low-cost ACO may be concerned that referring their patients to specialist physicians participating in a fixed-cost bundled payment program will reduce their ability to “gain-share” through cost reductions. Such potential conflicts IF YOU HAVEN’T REPORTED DATA ON QUALITY MEASURES THROUGH PQRS OR AS PART OF EHR MEANINGFUL USE, DO SO ASAP. advanced APM path will be excluded from MIPS adjustments. Instead, they will receive an annual incentive bonus consisting of 5% of their previous year’s total aggregate Medicare expenditures. To qualify for these enhanced payments, your APM must use similar quality measures employed by MIPS, employ an EHR, incur more than a “nominal financial risk” or already constitute a patient-centered medical home.3 Once physicians reach a threshold percentage of their Medicare payments through an approved advanced APM (25% in 2019 and 75% in 2023), they will be considered “qualifying participants.”4 Importantly, starting in 2026, the annual fee 8 CONTEMPOR ARYOBGYN.NE T will need to be resolved by CMS prior to full implementation. Take-home message Most US physicians taking care of Medicare patients will soon need to choose between MIPS and advanced APM pathways. In addition, even if you are an ob/gyn who cares for few Medicare patients, many commercial plans are likely to adopt a similar payment strategy. Importantly, you really need to at least tentatively choose between pathways by 2017 because data upon which CMS will calculate composite value scores will start to be collected then. In other words, physicians must begin the race toward value immedi- ately. So if you haven’t reported data on quality measures through PQRS or as part of EHR meaningful use, do so ASAP. Finally, many of your patients, when confronted by the choice between high-deductible, high co-pay, and high-premium plans versus lower-cost, capitated “HMO-like” plans, managed by clinically integrated networks of providers, will likely choose the latter. Thus, if you are not part of such a network, you may find yourself with a lot fewer patients in 2019. REFERENCES 1. Centers for Medicare & Medicaid Services. National Health Expenditure Data. https:// www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html. Accessed June 1, 2016. 2. US Department of Health & Human SerYLFHV$GPLQLVWUDWLRQWDNHVÀUVWVWHSWRLPSOH ment legislation modernizing how Medicare pays physicians for quality. http://www.hhs. gov/about/news/2016/04/27/administrationWDNHVÀUVWVWHSLPSOHPHQWOHJLVODWLRQPRG ernizing-how-medicare-pays-physicians. html. Accessed June 1, 2016. 3. AAFP.org. MACRA Ready: Frequently Asked Questions: Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). http:// www.aafp.org/practice-management/payment/medicare-payment/faq.html. Accessed June 1, 2016. 4. Mechanic RE. When new Medicare payment systems collide. N Engl J Med. 2016;374(18):1706–1709. Dr Lockwood, editor in chief, is Senior Vice President, USF Health, and Dean, Morsani College of Medicine, University of South Florida, Tampa. He can be reached at [email protected]. JUNE 2016 PIONEERS ONSITE MAMMOGRAPHY -/9"1,*,č / č*č,/ FROM OTHERS " ÃÌi>}À>«ÞÃÌi>ÌÜ`i>ÕÌÀÌÞvwVi>}À>«Þ ÃiÀÛVià and the pioneer in tele-tomosynthesis. We are the experts you can trust. 9JGP[QWFGEKFGVQCFFKPQHƂEGUETGGPKPIOCOOQITCRJ[UGTXKEGUVQ[QWT RCVKGPVQHHGTKPIV> " ÃÌi>}À>«Þ. n£x ÀÌ,`°7iÃÌvi `]čä£änx 855-405-9302 O N s i t e M a m m ogr a ph y. co m READERS REACT have a comment? SEND YOUR THOUGHTS TO [email protected] Cesarean best practices panel needed PEER-REVIEWED PEER-REVIEWED read with interest the article In my view if your cesarean secon cesarean sections [“Cetion rate is 38%, you aren’t even 1.3 MILLION The cesarean sarean epidemic: Are we trying. So don’t pretend. Primary epidemic: Are we too quick to cut? too quick to cut?,” April 2016 cesarean section rates nationally Contemporary OB/GYN] I am are reported as 22%. These numretired now, [but] I was very inbers use wrong denominators. It is I CESAREAN DELIVERY RATES IN THE UNITED STATES, 1991-2007 terested in my cesarean section not 22/100; it is really 22/40 or 45, rates [during my career] and so depending on the percent of priI am beyond disappointed now miparas in the population. Now to see a 50% increase in overall you are pushing rates of 50%. rates. Although there are numerous countervailing forces Richard W Zalar, Jr, MD, FACOG UNIVERSITY CITY, MISSOURI which complicate any attempt to a READ THE ARTICLE AND LET US lower and more reasonable rate, there KNOW WHAT YOU THINK. are still some OBs who achieve this CONTEMPORARYOBGYN.NET/CESAREAN-EPIDEMIC safely. These days cesarean sections are not epidemic, they are endemic. I would like to propose that Contemporary OB/GYN convene a best pracHorrendous complications are distices panel to hear what some in the qualifiers—your call. trenches actually do successfully. Discussions can include profesThere should be 3 to 5 panel memsional philosophies, interpretations of bers. Start at the top with laborist or recent positions by ACOG and SMFM, laborist-style (in the hospital) OBs and what works (maybe some clinical skilled anesthesia available (epidurals pearls; remember them?), managethat tailored for labor; a sensory, not ment examples—what would you do? motor block.) They should be preferLater panels can address less optit is always interesting to review arably at least 40 years old (some expemal practice settings and what can be ticles like this as I think we keep on rience, not fresh out of training). They achieved or not. digging into a problem that has no should have a backlog of at least 500 If the average national cesarean real solution as training and unrealisdeliveries that can be documented rates are 32%–33%, that also means tic expectations have taken obstetrics (again not from training; even hosthere are significant numbers of OBs to a different field of play. pital administrative data have been that have even higher rates. In my Fear of litigation, lack of training on easy enough to obtain for at least 2 old group, 62% of mothers would deoperative deliveries, lack of training decades). liver within 12 hours no matter what. on difficult deliveries, lack of incenPrimary cesarean section rates It might be cost- and health-effective tives for trial of labor after cesarean should be half the national average; to start a timer on admission and after section, and so on and so forth weigh this means around 11%. Management 12 hours just cut. It would at least be on the increase cesarean section we of first labor should be emphasized. honest. I CESAREAN DELIVERY RATES OBSTETRICS pelvic disproportion, or arrest of progress in labor. It is unlikely that maternal pelvis size has changed over the past 3 decades, but it is possible that birth weight has increased. In fact, evidence suggests that rates of macrosomia have increased over the past 2 decades.8 Other issues that contribute to increasing rates of cesarean delivery, possibly through the mechanism of birth weight, are maternal obesity and gestational weight gain.9,10 Without question, the proportion of obese women has increased over the past decade and higher weight classes are associated with even higher rates of cesarean.11,12 In addition, increased gestational weight gain has been associated with cesarean delivery and is commonly above standard guidelines.13 Another reason for increasing cesarean rates may be a rise in elective cesarean delivery, also known as cesarean delivery by maternal request Cesarean delivery may be a safe alternative to vaginal delivery but its use in 1 of 3 women giving birth in the US seems too high. by AARON B CAUGHEY, MD, PHD QUICK TAKE Maternal obesity and gestational weight gain may be contributing to rising rates of cesarean delivery. The most common indications for cesarean delivery are prior cesarean, failure to progress, and abnormal fetal heart tracing. ingly, the rise in TOLAC was accompanied by a slight decline in primary cesarean deliveries.4 In the 1990s, the increasing rates ran contrary to guidance from Healthy People 2010 (and then Healthy People 2020), which set a 15% goal for primary cesareans.5 The wide variation in cesarean rates among institutions is striking.6 The rate varies significantly even when controlling for characteristics that would account for indicated cesar- DR CAUGHEY is Professor and Chair, Department of Obstetrics Science University, Portland, Oregon. He reports ownership interest in MindChild Medical, Inc. eans. The statistics are dramatic and concerning, leading to these key questions: Why is the cesarean rate rising, and is the rise influencing maternal or neonatal outcomes? vaginally. Thus, even in this setting, it is unclear that maternal preferences are driving the increase in cesarean delivery rate. The topic of CDMR led to a National Institutes of Health (NIH) state-ofthe-science conference in 2006. The conclusion from this meeting was that future research was necessary to examine both the “current extent of CDMR and attitudes about it.”16 More recently, a study in the United States found that the vast majority of women would prefer to deliver vaginally.17 So, while some maternal demoCONTINUED ON PAGE 18 15 7 23 22 22 24 21 21 21 21 21 22 23 Why is the rate rising? One possible reason for the rise in the cesarean delivery rate may be that there has simply been a rise in the need for cesarean. The most common indication for a primary cesarean is cephalo- and Gynecology, School of Medicine, Oregon Health & 26 32 30 31 28 29 CESAREAN RATES PEAKED IN 2009 AT 32.9%, CAPPING STEADY INCREASES THAT STARTED IN 1996 Per 100 births n 2014, 1.3 million women in the United States delivered via cesarean, placing the rate at 32.2%, down just .7% from the peak in 2009.1 That year, cesarean rates hit 32.9%, capping steady increases that started in 1996, when the rate was 20.7%.2 The rapid rise (a 50% increase over 13 years) came on the heels of a decline in the cesarean rate from 23.7% in 1987 to 20.8% in 1997— the only time in the past 3 decades that it fell in a developed country.3 The drop in the late 1980s and early 1990s was accomplished primarily because trials of labor after cesarean (TOLACs) had been rare and the rate of attempts rose to more than 40% in women with prior cesareans. Interest- WOMEN IN THE UNITED STATES DELIVERED VIA CESAREAN IN 2014 (CDMR). Because there was no ICD9 code for CDMR, it is unclear what proportion of cesareans are due to it. One recent study, however, estimated the proportion as high as 4% in the United States.14 Interestingly, CDMR is more common in other countries, such as Brazil, Taiwan, and Chile. A study in Chile comparing women receiving private care (cesarean rate >40%) to women receiving public care (cesarean rate <20%) found that 8% of those receiving private care and 11% of those receiving public care stated a preference for cesarean delivery, with the vast majority preferring to deliver 1991 1992 and Celmatix, Inc. 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 SOURCE:CDC/NCHS, National Vital Statistics System 14 CONTEMPOR ARYOBGYN.NE T APRIL 2016 APRIL 2016 CONTEMPOR ARY OB/GYN 15 Familiarity with forceps helps keep rate low I 10 CONTEMPOR ARYOBGYN.NE T JUNE 2016 CESAREAN RATES currently observe. The attitude, as one of my senior residents used to say when I was in training, is that in obstetrics there are only 2 options: an easy vaginal delivery or an easy cesarean section. Of the group currently delivering at my institution in Washington State, I think only a couple of us do forceps deliveries and I dare to say that I am the only one in town who is comfortable with mid-pelvis forceps deliveries, which have helped me to keep a reasonable primary cesarean section rate. Tomas A Hernandez-Mejia, MD PASCO, WASHINGTON No incentives for VBACs S ince VBACs are now frowned upon, physicians will not do them. In fact, there is no incentive to do them. You have to spend much more time in labor and delivery because you have to be “readily available.” If you are a solo practitioner, you basically have to close down your office and babysit that one patient. You do not get reimbursed for all of the extra time, in fact you get reimbursed as if it was a routine vaginal delivery. On another point, reimbursement for a cesarean section is a lot more than that for a vaginal delivery. With all Obstetricians condemned to defensive position V ery well done, Dr Caughey. American ob practice fell off the cliff with the universal adoption of screening EFH rate monitoring and surrendering to the recommendation that operative obstetrics was not to be practiced. Through an inherent fault, ob is the specialty that has the fewest number of “Level A” research articles and guidance. Yet our specialty societies write opinions that are understandably broad yet are fodder for the nefari- HAVE YOUR SAY ONLINE JUNE 2016 READERS REACT ous few who are self serving and yield to the interests of those who pay them. The collateral damage is measurable and has had a deleterious effect on ob practice in this country. Unfortunately, and as a direct result of this perverse setting, our society is now conditioned to judge our care (quality) simply on the basis of outcome. The concept that pregnancy has no risk and a satisfactory outcome is certain condemns us to a de- of the healthcare cuts and reimbursements down, why on earth should a physician ever do a vaginal delivery? I am not an advocate of practicing this way and I still do VBACs, I do spend a lot of time with these patients and I am proud to say that I have one of the lowest cesarean section rates in the country. I am just giving reasons why I think that the cesarean section rate is higher than it should be. Patrick Skulemowski, DO BROWNSVILLE, TEXAS fensive position. In this scenario, we have historic ob provider burnout and unhappiness. If we were once again allowed to practice low-intervention ob and judged on the basis of best practice without Monday morning quarterbacking, we could make significant progress in lowering the cesarean delivery rate to the levels of 35 to 40 years ago without jeopardizing outcomes. Armando P Russo, MD VINELAND, NEW JERSEY CONTINUED ON PAGE 15 Do you think a best practices panel would be effective? Do you feel that more frequent use of forceps could help keep the cesarean rate down? What’s your opinion on reimbursement for VBACs? Let us know what you think by tweeting to @ContempOBGYN. CONTEMPOR ARY OB/GYN 11 Cervical ripening with CONTROL AT HAND CERVIDIL is easy to insert and remove1 INDICATION CERVIDIL Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor. CERVIDIL is designed to be released at approximately 0.3 mg/ hour over a 12-hour period. CERVIDIL should be removed upon onset of active labor or 12 hours after insertion. Upon removal of CERVIDIL, it is essential to ensure that the slab has been removed as it may have separated from the knitted polyester retrieval system and will continue delivering the active ingredient. IMPORTANT SAFETY INFORMATION Contraindications CERVIDIL is contraindicated in: • Patients with known hypersensitivity to prostaglandins • Patients in whom there is a clinical suspicion or definitive evidence of fetal distress where delivery is not imminent • Patients with unexplained vaginal bleeding during this pregnancy • Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion • Patients in whom oxytocic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity, such as previous cesarean section or uterine surgery (given the potential risk for uterine rupture and associated obstetrical complications, including the need for hysterectomy and the occurrence of fetal or neonatal death) • Patients already receiving intravenous oxytocic drugs • Multipara with 6 or more previous term pregnancies Warnings and Precautions • CERVIDIL is for hospital use only and should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities. • Use of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue causing, in rare circumstances, the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism). • Prostaglandins, including CERVIDIL, may augment the activity of oxytocic agents and their concomitant use is not recommended. CERVIDIL must be removed before oxytocin administration is initiated and a dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin. CERVIDIL is a registered trademark of Ferring B.V. © 2016 Ferring B.V. CV/807/2016/US Printed in U.S.A. April 2016 CERVIDIL IS THE1: • FDA-approved insert for cervical ripening • Single-dose cervical ripener • Controlled-release formulation • Retrievable insert with a half-life of 2.5 to 5 minutes Giving you cervical ripening control at your fingertips—from administration to retrieval. See what else you need to know about CERVIDIL at CERVIDIL.com/control • Uterine activity, fetal status, and the progression of cervical dilatation and effacement should be carefully monitored whenever the CERVIDIL vaginal insert is in place. With any evidence of uterine hyperstimulation, sustained uterine contractions, fetal distress, or other fetal or maternal adverse reactions, the vaginal insert should be removed. CERVIDIL should also be removed prior to amniotomy. • Caution should be exercised in the administration of CERVIDIL for cervical ripening in patients with ruptured membranes, in cases of non-vertex or non-singleton presentation, and in patients with a history of previous uterine hypertony, glaucoma, or a history of childhood asthma, even though there have been no asthma attacks in adulthood. • Long-term carcinogenicity and fertility studies have not been conducted with CERVIDIL. No evidence of mutagenicity has been observed with prostaglandin E2 in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or Ames Assay. • Prostaglandin E2 has produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since CERVIDIL is administered after the period of organogenesis. Prostaglandin E2 has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. • The safety and efficacy of CERVIDIL has been established in women of a reproductive age and women who are pregnant. Although safety and efficacy has not been established in pediatric patients, safety and efficacy are expected to be the same for adolescents. • Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of postpartum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction. In these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate postpartum period. An increased risk of postpartum disseminated intravascular coagulation has been described in patients whose labor was induced by physiologic means, either with dinoprostone or oxytocin. Adverse Reactions • In clinical trials, the most commonly occurring adverse reactions were uterine hyperstimulation with fetal distress (2.8% vs 0.3% for placebo), uterine hyperstimulation without fetal distress (4.7% vs 0%), and fetal distress without uterine hyperstimulation (3.8% vs 1.2%). • Drug-related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received CERVIDIL. Please see Brief Summary of full Prescribing Information on the next page. Reference: 1. Cervidil [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. CERVIDIL® (dinoprostone, 10 mg) Vaginal Insert Uterine activity, fetal status and the progression of cervical dilatation and effacement should be carefully monitored whenever the dinoprostone vaginal insert is in place. With any evidence of uterine hyperstimulation, sustained uterine contractions, fetal distress, or other fetal or maternal adverse reactions, the vaginal insert should be removed. BRIEF SUMMARY Please consult package insert for full Prescribing Information. INDICATIONS AND USAGE Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor. Upon removal of Cervidil, it is essential to ensure that the slab has been removed as it may have separated from the knitted polyester retrieval system and will continue delivering the active ingredient. CONTRAINDICATIONS Cervidil is contraindicated in: • Patients with known hypersensitivity to prostaglandins. • Patients in whom there is clinical suspicion or definite evidence of fetal distress where delivery is not imminent. • Patients with unexplained vaginal bleeding during this pregnancy. • Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion. • Patients in whom oxytocic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery (see PRECAUTIONS and ADVERSE REACTIONS). • Patients already receiving intravenous oxytocic drugs. • Multipara with 6 or more previous term pregnancies. WARNINGS For hospital use only Cervidil should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of postpartum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction (See ADVERSE REACTIONS, Post-marketing surveillance). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum period. The Clinician should be alert that use of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism). An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by physiologic means, either with dinoprostone or oxytocin. 2. Drug Interactions: Cervidil may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert. No other drug interactions have been identified. 3. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term carcinogenicity and fertility studies have not been conducted with Cervidil (dinoprostone) Vaginal Insert. No evidence of mutagenicity has been observed with prostaglandin E2 in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or Ames Assay. In study 101-801 (with the retrieval system) cases of hyperstimulation reversed within 2 to 13 minutes of removal of the product. Tocolytics were required in one of the five cases. In cases of fetal distress, when product removal was thought advisable there was a return to normal rhythm and no neonatal sequelae. Five minute Apgar scores were 7 or above in 98.2% (646/658) of studied neonates whose mothers received Cervidil. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil, there were no deleterious effects on physical examination or psychomotor evaluation (18). Post-marketing surveillance Immune System Disorders: Hypersensitivity Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See WARNINGS Section) Reproductive system: Reports of uterine rupture have been reported in association with use of Cervidil some required a hysterectomy and some resulted in subsequent fetal or neonatal death. 4. Pregnancy, Teratogenic Effects: Prostaglandin E2 has produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since Cervidil (dinoprostone) Vaginal Insert is administered after the period of organogenesis. Prostaglandin E2 has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. Vascular Disorders: Hypotension 5. Pediatric Use: The safety and efficacy of Cervidil has been established in women of a reproductive age and women who are pregnant. Although safety and efficacy has not been established in pediatric patients, safety and efficacy are expected to be the same for adolescents. Cervidil is used as a single dosage in a single application. Overdosage is usually manifested by uterine hyperstimulation which may be accompanied by fetal distress, and is usually responsive to removal of the insert. Other treatment must be symptomatic since, to date, clinical experience with prostaglandin antagonists is insufficient. ADVERSE REACTIONS Cervidil is well tolerated. In placebo-controlled trials in which 658 women were entered and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported. Table 1 Total Cervidil – Treated Drug-Related Adverse Events Controlled Studies1 PRECAUTIONS 1. General Precautions: Since prostaglandins potentiate the effect of oxytocin, Cervidil must be removed before oxytocin administration is initiated and the patient’s uterine activity carefully monitored for uterine hyperstimulation. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Cervidil should also be removed prior to amniotomy. Active Placebo Uterine hyperstimulation with fetal distress 2.8% 0.3% Uterine hyperstimulation without fetal distress 4.7% 0% Fetal Distress without uterine hyperstimulation 3.8% 1.2% 320 338 N STUDY 101-8012 Cervidil is contraindicated when prolonged contraction of the uterus may be detrimental to fetal safety and uterine integrity. Therefore, Cervidil should not be administered to patients with a history of previous cesarean section or uterine surgery given the potential risk for uterine rupture and associated obstetrical complications, including the need for hysterectomy and the occurrence of fetal or neonatal death. Caution should be exercised in the administration of Cervidil for cervical ripening in patients with ruptured membranes, in cases of non-vertex or non-singleton presentation, and in patients with a history of previous uterine hypertony, glaucoma, or a history of childhood asthma, even though there have been no asthma attacks in adulthood. Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil. Active Placebo Uterine hyperstimulation with fetal distress 2.9% 0% Uterine hyperstimulation without fetal distress 2.0% 0% Fetal Distress without uterine hyperstimulation 2.9% 1.0% 102 104 N 1 Controlled Studies (with and without retrieval system) Controlled Study (with retrieval system) 2 Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism To report SUSPECTED ADVERSE REACTIONS, contact FERRING PHARMACEUTICALS INC. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. OVERDOSAGE The use of beta-adrenergic agents should be considered in the event of undesirable increased uterine activity. For more information, go to www.CERVIDIL.com or call 1-888-FERRING (1-888-337-7464). MANUFACTURED IN SCOTLAND MANUFACTURED FOR: FERRING PHARMACEUTICALS INC. PARSIPPANY, NJ 07054 Rev. 02/16 6870-03 CV/1178/2016/US CESAREAN RATES READERS REACT CONTINUED FROM PAGE 11 IN REPLY: The clinicians who wrote in make great, relevant points. As a clinician first, and researcher/educator/administrator second, I am always interested in the viewpoints of busy clinicians. Dr Zalar makes the point that the journal should convene a best practices panel. The ACOG/SMFM/NICHD document that we published in spring of 2014 was just that—the efforts from a collection of clinicians from around the country, vetted by the existing evidence, and winnowed down to those interventions that we thought would make the biggest difference. But I would agree that is just the starting point. If each institution convened such a panel for internal review, it would make a big difference. Five years ago, we started reviewing all cesareans at my institution and discussing why they occurred, and in just a few months, there was a rapid reduction in cesarean rates from 34% to 25%. The second letter mentions the use of forceps, which I am sad to say, has continued to wane in the United States. I have trained residents to use the obstetric forceps for the past 17 years and even last year after one of our residents joined our faculty, she texted me after her first night on call to tell me that they had done 2 forceps deliveries overnight. We are not a high-volume program, but remain dedicated to training our residents to perform forceps deliveries. The forceps, in my opinion, are a more effec- MOST WOMEN WE CARE FOR ARE EXPERIENCING A NORMAL PHYSIOLOGIC PROCESS, NOT PATHOLOGY. tive and safer approach to the operative vaginal delivery than the vacuum and I believe that all it takes to ensure safe training of our residents is a faculty commitment to include trainees in forceps deliveries. In fact, with improved simulation equipment, I believe that forceps training is easier and safer than ever and should be strongly encouraged nationwide. Dr Skulemowski comments that there is no economic incentive to do VBACs. This is absolutely true. In fact, WE WANT TO HEAR FROM YOU Want to let Contemporary OB/GYN know what you thought of this month’s cover story? Feel like telling Dr Lockwood what you thought of his latest editorial? There are lots of ways to interact with us. You can: Email Dr Lockwood at [email protected] Comment online at the bottom of .COM any Contemporary OB/GYN article Leave comments on our Facebook page: facebook.com/ContempOBGYN Follow us and tweet to @ContempOBGYN there is really no incentive to do vaginal deliveries at all. The cesarean delivery is almost always quicker from the clinician perspective, less intrusive in a busy schedule, usually reimburses at a higher rate, and reduces litigation exposure. But, while VBAC rates have reduced and cesarean rates have increased, the majority of deliveries are still vaginal. Thus, many clinicians are still practicing thoughtful, evidence-based medicine, trying to do the right thing for the women they care for, much like the letter writer. As a society, could we do better? Yes, we could properly reimburse and incentivize clinicians to achieve higher vaginal delivery rates. During labor, one of the principle activities is ongoing fetal assessment. Somehow this activity of frequent fetal assessment has been rolled up into the global charge for a delivery. Yes, with a prolonged labor, this might mean hours of work, whereas for a scheduled cesarean, it could be a single nonstress test (NST). Clinicians should be able to bill for the hourly NSTs or contraction stress tests being performed. In the end, the large majority of women we care for on labor and delivery are experiencing a normal physiologic process, not pathology. Thus, what they need is support, pain relief, and ongoing vigilance to ensure that complications are prevented or managed to minimize harm. The cesarean delivery is a remarkable tool of the twentieth century that can and has saved countless lives. However, we need to use it judiciously so that it does not cost more lives than it saves. Aaron B Caughey, MD, PhD The editors reserve the right to shorten or edit letters and comments. JUNE 2016 CONTEMPOR ARY OB/GYN 15 PEER-REVIEWED OBESITY Maternal obesity and the fetal brain The problems go beyond fetal metabolic programming. Obesity has effects on fetal neurodevelopment. by ANDREA G EDLOW, MD, MSC, AND LARISSA H MATTEI, BA I n the United States, more than 60% of reproductive-age women are overweight and 35% are obese, representing a 70% increase in pre-pregnancy obesity.1,2 Childhood obesity and early-onset metabolic syndrome have risen in parallel.1-3 While it is now relatively well-known that maternal obesity, maternal high-fat diet, and high gestational weight gain (GWG) may have harmful effects on fetal and offspring metabolic programming, awareness of the potential harmful programming effects on the fetal brain is less widespread. The effect of maternal obesity, highfat diet, and GWG on fetal neurodevelopment and offspring behavior is the focus of this review. 'DWDIURPODUJHHSLGHPLRORJLFVWXGLHVKDYHGHPRQVWUDWHGDQ QUICK TAKE DVVRFLDWLRQEHWZHHQPDWHUQDOREHVLW\DQGQHXURGHYHORSPHQWDO PRUELGLWLHVLQRIIVSULQJ ,PSDLUHGGRSDPLQHUJLFVLJQDOLQJKDVEHHQLPSOLFDWHGLQWKH GHYHORSPHQWRIFHUWDLQSV\FKLDWULFGLVRUGHUVLQKXPDQV Evidence from epidemiologic studies Compelling data from large epidemiologic studies have demonstrated an association between maternal obesity and a variety of neurodevelopmental morbidities in offspring. All relationships, odds ratios, relative risks, and IQ decrements reported here achieved statistical significance in the referenced studies, unless otherwise indicated. Increased odds of cognitive deficits, decreased IQ, and intellectual disability Maternal obesity may increase the risk for intellectual disability or cognitive deficits in offspring from 1.3- to 3.6-fold.4-7 Maternal obesity has been linked to decrements in offspring cognition (eg, 2–5 points lower IQ in offspring of obese women compared to non-obese counterparts),4,8,9 with every increase of 1 unit in maternal prepregnancy BMI found to be asso- DR EDLOW LVDQDWWHQGLQJSK\VLFLDQLQWKH'LYLVLRQ MS MATTEI is a fourth-year medical student at Tufts RI0DWHUQDO)HWDO0HGLFLQH'HSDUWPHQWRI2E*\Q University School of Medicine, Boston, Massachusetts. Tufts Medical Center, Boston, Massachusetts, and an 1HLWKHUDXWKRUKDVDFRQÁLFWRILQWHUHVWWRUHSRUWLQ investigator at the Mother Infant Research Institute, UHVSHFWWRWKHFRQWHQWRIWKLVDUWLFOH Tufts Medical Center, Boston. 16 CONTEMPOR ARYOBGYN.NE T JUNE 2016 OBESITY ciated with a significant reduction in offspring IQ and non-verbal IQ, suggesting a dose-response relationship.8 High GWG seems to augment this association.4 Maternal pre-pregnancy obesity pls GWG of > 40 lb was associated with a 3-fold increase in offspring IQ deficit (mean of 6.5 points lower).4 Of note, extremely low maternal prepregnancy BMI (<18.5 kg/m2) has also been significantly associated with lower offspring IQ, although the reported decrement is less than in the setting of maternal obesity.4,6 Increased odds of autism spectrum disorders (ASD) The majority of studies that have examined a link between high maternal BMI and childhood diagnosis of ASD have found a significant positive association.10-13 This risk may be further augmented by intrauterine growth restriction (IUGR),14 preterm birth,12 high GWG,13 gestational or pre-gestational diabetes,10,11 and preeclampsia.15 Two recent studies including matched sibling analyses failed to find a significant relationship between maternal pre-pregnancy BMI and ASD risk,16,17 suggesting that maternal BMI might be a proxy marker for other familial risk factors conferring an increased risk of ASD in offspring. High GWG was independently associated with offspring ASD risk, even in studies that failed to find an association with maternal pre-pregnancy obesity.16,17 Of note, paternal obesity has also been demonstrated to be independently associated with increased ASD risk in offspring.18 Increased odds of attention deficit hyperactivity disorder (ADHD) A dose-dependent increase in ADHD JUNE 2016 MATERNAL OBESITY MAY INCREASE THE RISK FOR INTELLECTUAL DISABILITY OR COGNITIVE DEFICITS IN OFFSPRING FROM 1.3-FOLD 3.6-FOLD TO symptoms in children was noted in Swedish, Danish, and Finnish pregnancy cohorts as maternal pre-pregnancy BMI increased from overweight to obese.19 Later studies confirmed this association with up to a 2.8-fold increased risk of offspring ADHD compared to non-obese counterparts.20-22 A recent study found that the association between maternal obesity and increased risk of ADHD in offspring was true for white but not black women.23 Another study failed to find an association between maternal obesity and offspring ADHD after adjusting for confounders such as socioeconomic status.24 Still, the preponderance of epidemiologic evidence suggests that maternal obesity is associated with ADHD risk in offspring. Increased odds of cerebral palsy (CP) A dose-dependent increase in offspring CP risk has been noted as maternal BMI increases from overweight to morbidly obese (from 1.2 to 3.0 times increased odds).25-28 One study reported that each unit increase in maternal BMI raised the risk of CP by PEER-REVIEWED 7%, and each kg of additional weight at 34 weeks increased the risk of CP by 2%.25 While underlying mechanisms have not been fully elucidated, some have postulated that maternal inflammation may be causative, as obesity induces a chronic inflammatory state, and other maternal inflammatory conditions such as chorioamnionitis are known to confer an increased risk for CP.26,29 Limitations of existing epidemiologic data The aforementioned studies defined maternal pre-pregnancy obesity as a reported pre-pregnancy or measured early pregnancy BMI ≥30 kg/m2 or absolute pregnancy weight >90 kg. These definitions do not identify percent of weight due to body fat and/or the distribution of body fat, both of which may have bearing on maternal and fetal health.27,30 Epidemiological studies are also limited by their inability to demonstrate causation or to elucidate mechanism; the fact that some of these data are from large US or European population-level studies in the 1970s–1990s, when obesity was less prevalent; and the fact that many of these studies suffer from attrition, sampling biases for control groups, reliance on parental report to evaluate past exposure and offspring diagnosis, lack of statistical power, and inability to adjust for confounders.31 Physiology of obese pregnancy The primary mechanisms that have been proposed to underlie the risk of neurodevelopmental morbidity in offspring of obese women include: 1) I n f l a m m a t i o n - i n d u c e d CONTEMPOR ARY OB/GYN 17 PEER-REVIEWED malprogramming 2) Relative excess and/or deficiencies of circulating nutrients 3) Metabolic hormone-induced malprogramming, and 4) Impaired development of serotonergic and dopaminergic signaling These mechanisms are not necessarily distinct from one another, and feature several interconnections (Figure). A brief summary of the evidence in these areas follows. Inflammation-induced malprogramming Both maternal obesity and pregnancy itself are associated with chronic systemic inflammation.32 Obese women have been demonstrated to have exaggerated physiologic responses to pregnancy, with increased circulating levels of pro-inflammatory cytokines compared to their normal weight counterparts.33-35 Maternal BMI has been shown to be directly correlated with maternal blood concentrations of cytokines and with activation of pro-inflammatory pathways in the placenta.33,36 Placental and intrauterine inflammation are associated with altered fetal cytokine expression, fetal neuronal damage, and changes in neonatal brain gene expression.35,37 Elevated levels of maternal pro-inflammatory cytokines during gestation have been linked to an increased risk for ASD and neurodevelopmental delay in children.38 Children with ASD have also been shown to have elevated plasma markers of inflammation.39,40 It is postulated that underlying maternal and placental inflammation in the setting of maternal obesity plays a key role in fetal brain inflammation 18 CONTEMPOR ARYOBGYN.NE T OBESITY and subsequent abnormal offspring neurodevelopment.27,35 This concept has been corroborated by animal studies. Rat offspring exposed to maternal obesity and a high-fat diet in utero demonstrated increased neuronal and systemic inflammation, poor memory retention, and changes in anxiety levels and spatial reasoning.27,41,42 implicated in abnormal neurodevelopment of the fetus.27 Obese pregnant women were also found to have lower levels of nutritional antioxidants, suggesting that fetuses of obese women may be exposed to more oxidative stress and inflammation than those of lean women.47 FETUSES OF OBESE WOMEN MAY BE EXPOSED TO MORE OXIDATIVE STRESS AND INFLAMMATION THAN FETUSES OF LEAN WOMEN. Rodent and non-human primate models of maternal obesity and highfat diet in pregnancy have demonstrated increased brain inflammation, decreased sociability, increased hyperactivity, and impaired hippocampal learning in offspring.42-44 A murine model of maternal inflammation demonstrated deficits in offspring social behavior, and highlighted a critical role for the cytokine interleukin-6 in mediating these behavioral changes.45 Relative excess or deficiency of circulating nutrients Maternal obesity is associated with increased circulating free fatty acids and glucose, due to diet, increased insulin resistance, and increased adipose tissue lipolysis.27,31,46 The fetus is exposed to an excess of certain circulating nutrients. Obesity has also been shown to coexist with states of subclinical malnutrition characterized by excess energy intake with a relative deficiency in circulating micronutrients.27 Excess free fatty acids and glucose in maternal circulation and deficiencies of vitamin D, B12, folate, and iron have been Metabolic hormone-induced malprogramming Fetuses of obese women may be chronically exposed to insulin resistance and a glucose-rich environment, even in the absence of diagnosed gestational or pre-gestational diabetes.48 The fetal pancreas compensates by producing increased insulin, and the pro-inflammatory environment compounds fetal insulin resistance via inflammatory changes in fetal adipose tissue.49 Insulin acts on the fetal brain as a growth factor, and excess insulin exposure can cause disruptions in neural circuitry, brain development, and behavior.48 Maternal hyperinsulinemia in the setting of Type 2 diabetes and gestational diabetes have been shown to be associated with increased risk of ASD and neurodevelopmental delay.50 Leptin levels are also elevated in obese mothers.50,51 Leptin functions as a critical neurotrophic factor, and leptin signaling abnormalities during fetal development have been associated with decreased neuronal stem cell differentiation and growth.52 Leptin re- JUNE 2016 NEW! Easy to dispense safety packaging 200 mg of DHA and 30 mg of Iron I Tiny, complete softgel with 14 key vitamins and minerals 40% More Folic Acid than the leading prescription prenatal vitamin* Gluten, lactose, and sugar-free May cost you $0 co-pay! Learn more: vitaMedMDRx.com/samples/COB *Branded prescription prenatal as of 5/16 © 2016 TherapeuticsMD, Inc. VITP-0125 5/16 Call 877-577-6807 or Ask Your Doctor vitaPearl is a trademark of TherapeuticsMD, Inc. #vitaMedMD @vitaMedMD @vitaMedMD #vitaPearl PEER-REVIEWED OBESITY ceptors are widely distributed in brain regions involved in behavioral regulation,53 so derangement in leptin signaling during key developmental pe- riods is another potential mechanism underlying abnormal neurodevelopment in fetuses of obese women.13 Impaired development of serotonergic and dopaminergic signaling Maternal obesity may also increase the risk of neurodevelopmental and FIGURE. MECHANISMS UNDERLYING INTRAUTERINE MALPROGRAMMING AND OFFSPRING MORBIDITY IN MATERNAL OBESITY Maternal obesity and gestational weight gain Changes in placenta and intrauterine environment Altered maternal physiology Fetal malprogramming Fetal brain Placenta LQÁDPPDWLRQ&53,/ 71)α DGLSRVHWLVVXHOLSRO\VLV ))$71)α,/,/β KHSDWLF9/'/VHFUHWLRQ R[LGDWLYHVWUHVV ,QVXOLQUHVLVWDQFH LQVXOLQ JOXFRVH +\HUOHSWLQHPLD LQÁDPPDWLRQ,/ ,/71)α) ))$JOXFRVH 3RRUSODFHQWDOJURZWK DQGLPSODQWDWLRQ $EQRUPDO+7'$VLJQDOLQJ LQÁDPPDWLRQ R[LGDWLYHVWUHVV OHSWLQ /LSRWR[LFLW\ 1HXURQDOPLJUDWLRQGHIHFWV Fetal liver LQÁDPPDWLRQ R[LGDWLYHVWUHVVDQG PLWRFKRQGULDOG\VIXQFWLRQ KHSDWLFOLSLGV $OWHUHG,*)H[SUHVVLRQ Offspring morbidity Abnormal brain development: DXWLVPVSHFWUXP GLVRUGHUDWWHQWLRQ GHÀFLWK\SHUDFWLYLW\ GLVRUGHUFRJQLWLYH GHÀFLWVFHUHEUDO SDOV\ Metabolic complications: ,QVXOLQUHVLVWDQFH K\SHUJO\FHPLD K\SHULQVXOLQHPLD HDUO\RQVHWREHVLW\ QRQDOFRKROLFIDWW\ OLYHUGLVHDVHV\V WROLFK\SHUWHQVLRQ LPL Fetal pancreas Maternal free fatty acids, TGs IL-1, IL-6, TNF-α LQÁDPPDWLRQ LQVXOLQ $OWHUHG,*)DQG*/87 H[SUHVVLRQ Early environment XWHULQHLQÁDPPDWLRQ OLSLGWUDQVIHUWRIHWXV EODVWRF\VWLQÁDPPDWLRQ $OWHUHGEODVWRF\VWDQG XWHULQHJHQHH[SUHVVLRQ Fetal adipose LQÁDPPDWLRQ&53,/71)α) WUDQVFULSWLRQIDFWRU33$5γDGLSRF\WH K\SHUWURSK\OLSRJHQHVLVDQG))$UHOHDVH )HWDOPDOSURJUDPPLQJUHVXOWVLQQHXURGHYHORSPHQWDODQGPHWDEROLFPRUELGLW\IRURIIVSULQJDQGWKHVHWZRGLVSDUDWHW\SHVRI PRUELGLW\PD\RFFXUYLDWKHVDPHXQGHUO\LQJPHFKDQLVPV $EEUHYLDWLRQV+7VHURWRQLQ&53&UHDFWLYHSURWHLQ'$GRSDPLQH))$IUHHIDWW\DFLGV*/87JOXFRVHWUDQVSRUWHUW\SH,*) LQVXOLQOLNHJURZWKIDFWRU,/LQWHUOHXNLQ/3/OLSRSURWHLQOLSDVH33$5γSHUR[LVRPHSUROLIHUDWRUDFWLYDWHGUHFHSWRUJDPPD7* WULJO\FHULGHV71)WXPRUQHFURVLVIDFWRU9/'/YHU\ORZGHQVLW\OLSRSURWHLQ 20 CONTEMPOR ARYOBGYN.NE T JUNE 2016 Your time. Your content. Download the free app. ContemporaryOBGYN.net/COGApp PEER-REVIEWED psychiatric disorders through abnormal development of the serotonergic (5-hydroxytryptamine or 5-HT) and dopaminergic (DA) systems. 5-HT signaling plays a significant role in neuronal migration, cortical neurogenesis, and synaptogenesis during fetal brain development.50,54 In murine and nonhuman primate models, offspring exposed to maternal high-fat diet had decreased 5-HT synthesis, and increased anxiety behavior, hyperactivity, and hypothalamic inflammation.31,48 Subclinical inflammation in maternal obesity may also decrease 5-HT production in offspring through increased breakdown of the 5-HT precursor tryptophan.50 In rodent models, pro-inflammatory cytokines have been demonstrated to reduce 5-HT neuron axonal density and embryonic neuronal survival in brain regions critical for behavioral regulation.55,56 Suppressed 5-HT synthesis has been observed in humans with ADHD, ASD, anxiety, and depression.31,48 Thus, altered 5-HT production may be one mechanism by which maternal obesity increases risk for neurodevelopmental disorders in offspring. The dopaminergic system mediates reward neural circuitry and is similarly affected by maternal obesity. Rat offspring exposed to high-fat diets in utero had impaired mesolimbic dopaminergic signaling, resulting in impaired stress response and reward response to food.57,58 In mice, a maternal highfat diet caused epigenetic changes in offspring DNA leading to dopamine dysregulation and changes in food preferences.59 Offspring changes in dopaminergic signaling may again be mediated through maternal inflammation; in a rat model of maternal inflammation, 22 CONTEMPOR ARYOBGYN.NE T OBESITY dopamine circuitry in offspring was dysregulated.60 Impaired dopaminergic signaling has been implicated in the development of ASD, ADHD, disordered eating, and other psychiatric disorders in humans.48 ga-3 fatty acids have demonstrated reduction in maternal and placental inflammation.64 An ongoing clinical trial in obese pregnant women employs BMI-based prenatal micronutrient supplementation, with the goal of decreasing maternal and fetal oxida- OBSERVATIONAL DATA HAVE POINTED TO OMEGA-3 AND OMEGA-6 FATTY ACIDS AS POSSIBLE CANDIDATE THERAPEUTICS IN MATERNAL OBESITY. Exploratory therapies Maternal lifestyle and dietary changes, metformin treatment, and nutrient supplementation have all been explored as interventions to improve offspring neurodevelopment in maternal obesity.61-66 In animal studies, prepregnancy and lactational change from a high-fat diet to a control diet reduced offspring adiposity, circulating leptin, and anxiety behaviors.61 In a rat model of diet-induced obesity, maternal metformin treatment reduced fetal and placental inflammation.62 Observational data have pointed to polyunsaturated fatty acids, including omega-3 and omega-6 fatty acids, as possible candidate therapeutics in maternal obesity. Omega-3 fatty acids protect against brain inflammation and enhance serotonin signaling.31 Maternal omega-3 fatty acid deficiency has been associated with increased risk of offspring ASD and ADHD.63 A retrospective analysis of data from the Nurses’ Health Study II suggested that maternal intake of high levels of omega-6 fatty acids was associated with a 34% reduction in offspring ASD risk.65 Human pilot studies of obese maternal supplementation with ome- tive stress and inflammation.66 Applications to patient care r 1SFDPODFQUJPO DPVOTFMJOH PG obese and overweight women may be appropriate to discuss risks and to encourage weight loss and adoption of a healthy diet prior to pregnancy. r .BUFSOBM QSFDPODFQUJPO MJGFTUZMF change and weight loss may also reduce the risk for preeclampsia and gestational/pregestational diabetes, which have also been associated with iatrogenic prematurity and an increased risk for ASD and other neurodevelopmental morbidity in offspring. r&WJEFODFJTJOTVŁDJFOUUPSFDPNmend routine omega-3 or omega-6 fatty acid supplementation in obese pregnant women to reduce the risk of offspring neurodevelopmental morbidity. r&WJEFODFJTJOTVŁDJFOUUPSFDPNmend routine use of metformin in obese pregnant women to reduce the risk of offspring neurodevelopmental morbidity. FOR REFERENCES VISIT contemporaryobgyn.net/obesity-fetal-brain JUNE 2016 ™ FemTouch Laser Treatment For vaginal health in post-menopausal and post-natal women Serving the OBGYN laser market since 1979 3\TLUPZ H SLHKLY PU [OL TLKPJHS SHZLY PUK\Z[Y` OHZ ILLU WYV]PKPUN ZVS\[PVUZ [V 6).@5WYHJ[PJLZMVY`LHYZ;OL-LT;V\JO™I`3\TLUPZVLYZH]HNPUHSHUK ZRPU^VYRZ[H[PVU>P[OQ\Z[HÄ]LTPU\[L]HNPUHSOLHS[OWYVJLK\YL[OL]HNPUHSJHUHS HJOPL]LZYLTVKLSPUNVM[OLT\JV\ZLWP[OLSP\TSH`LY;OL-LT;V\JOVLYZTH_PT\T ]LYZH[PSP[`MYVT[OLZ\YNPJHSZ\P[L[VZ[HUKHSVULWYP]H[LWYHJ[PJLZ The FemTouch treats post-menopausal and post-natal symptoms, including: ₔ Endometriosis ₔ Vaginal health ₔ Cone biopsies ₔ Condyloma ₔ 6OFWFOQJHNFOUBUJPO and dyschromia ₔ Pigmentation ₔ Fine lines and scars Contact your dedicated Lumenis representative [VÄUKV\[TVYLHIV\[[OL-LT;V\JOVYJHSS! 1877.LUMENIS I WWW.LUMENIS.COM ¸0OH]L\ZLKTHU`KL]PJLZHUKSHZLYZMVY^VTLU»Z]HNPUHSOLHS[OHUK0ÄUK[OL3\TLUPZ FemTouch is very user friendly. It delivers the best results for treatment of vaginal atrophy, urinary incontinence and vaginal laxity. The treatment takes about 3-5 minutes. Patient’s tolerate the treatment well and experience no pain. I am very happy with my overall L_WLYPLUJL^P[O[OL3\TLUPZ-LT;V\JO3HZLY¹ – Darush Mohyi, M.D., Gynecology & Reproductive Medicine La Jolla Cosmetic Laser Clinic, La Jolla, CA ©2016. All Rights Reserved. The Lumenis Group of Companies. PB-2005117 rev A PEER-REVIEWED OBESITY Morbidly obese gravidas: Labor or not? Vaginal delivery is the least morbid, but a trial of labor after cesarean is not always successful. by RODNEY K EDWARDS, MD, MS Y ou are covering the Labor and Delivery unit when a patient presents for a scheduled induction of labor. She is a 35-year-old African-American P1001 at 40 weeks gestational age who had a prior cesarean delivery (CD) due to arrest of dilation at 8 cm. She is 5 ft 3 in tall and weighs 280 lb (body mass index [BMI] 50 kg/m2). Her pregnancy has been uncomplicated, and the estimated fetal weight is 4000 g. Is trial of labor after cesarean (TOLAC) in this patient’s best interest? What if she were nulliparous and, therefore, did not have a history of a prior cesarean delivery? TOLAC in the general population Prior to the 1980s, because labor after a previous cesarean delivery was be- Morbidly obese women who have had a prior cesarean and wish to QUICK TAKE have a trial of labor (TOLAC) face increased risks if the trial fails. The iikelihood of morbidity with TOLAC is inversely proportional to the likelihood of a successful vaginal delivery. lieved to be dangerous, many obstetricians recommended repeat cesareans for all subsequent births to women with a previous such delivery. Since then, TOLAC has been advocated as a reasonable alternative for women with a previous cesarean delivery via a low transverse uterine incision. Practice Bulletin No. 115 from the American College of Obstetricians and Gynecologists (ACOG) states that “ … a failed labor … compared with vaginal birth after cesarean (VBAC), is associated with increased maternal and perinatal morbidity. Assessment of individual risks and the likelihood of VBAC is, therefore, important in determining who are appropriate candidates for TOLAC.”1 The statement is purposefully vague in order to define a range in standard of care, but what degree of risk is tolerable and what likelihood of VBAC success is needed for a patient to be an “appropriate candidate” for TOLAC? Twenty years ago, McMahon and colleagues published a populationbased, longitudinal study of 6138 women in Nova Scotia who had a single prior cesarean delivery and delivered a live singleton infant during the study period. The overall rate of DR EDWARDS is Professor and Chief, Section of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, 8QLYHUVLW\RI2NODKRPD+HDOWK6FLHQFHV&HQWHU2NODKRPD&LW\+HKDVQRFRQÁLFWRILQWHUHVWWRUHSRUWLQUHVSHFWWRWKH content of this article. 24 CONTEMPOR ARYOBGYN.NE T JUNE 2016 OBESITY TOLAC RCD VBAC RCD RCD Fewest complications Most complications Intermediate likelihood of complications FIGURE 1 Many women with a previous cesarean delivery may choose between TOLAC and RCD without labor. TOLAC may result in a VBAC, the delivery outcome with the lowest risk of complications, or an RCD after failed labor, the delivery outcome with the highest risk of complications. Women who undergo RCD without labor have a risk of complications that falls between the other 2 groups. Abbreviations: RCD, repeat cesarean delivery; TOLAC, trial of labor after cesarean; VBAC, vaginal birth after cesarean maternal complications did not differ significantly between women who attempted TOLAC (considering collectively both women having a VBAC and those requiring a repeat cesarean delivery after failed TOLAC) and those who elected a repeat cesarean delivery without labor. However, major complications (hysterectomy, uterine rupture, and/or operative injury) were almost twice as likely in the group who attempted TOLAC (again, considering collectively both women having a VBAC and those requiring a repeat cesarean delivery after failed TOLAC) (adjusted odds ratio [aOR] 1.8, 95% confidence interval [CI] 1.1–3.0).2 This difference was driven by the fact that major complications were 5 times as likely with failed TOLAC attempts compared to successful ones (aOR 5.1, 95% CI 2.8–9.4). Patients electing repeat cesarean delivery JUNE 2016 without labor had rates of major complications intermediate between the successful and unsuccessful TOLAC groups (Figure 1).2 Data from this and other studies contributed to the waning enthusiasm for VBAC in the United States— the rate of VBAC in 1996 was 28%; it has been <12% every year since 2004.3 Because the likelihood of morbidity with TOLAC is inversely proportional to the likelihood of success (ie, vaginal delivery), it is helpful, when counseling patients about TOLAC versus repeat cesarean delivery without labor, to consider a woman’s individual likelihood of TOLAC success. A useful calculator is available from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network at https://mfmu. bsc.gwu.edu/PublicBSC/MFMU/VG- PEER-REVIEWED BirthCalc/vagbirth.html. This calculator takes into account the patient’s age, BMI, race/ethnicity, number of prior vaginal deliveries, and primary indication for previous cesarean delivery.4 TOLAC in morbidly obese women Multiple studies have reported that morbid obesity is a risk factor for failed TOLAC. Using an unconventional definition of >300 lb at the first prenatal care visit, Chauhan et al. reported a VBAC success rate of only 13% in morbidly obese women and recommended repeat cesarean delivery without labor in such patients.5,6 Using a more conventional definition of morbid obesity (BMI ≥40 kg/m2 at the first prenatal visit), Edwards et al. reported a VBAC success rate of 57%. However, despite success among most patients who attempted TOLAC, puerperal infections were 3 times as likely in the TOLAC group compared to the elective repeat cesarean delivery group, and there was no cost benefit to TOLAC compared with elective repeat cesarean delivery.7 Hibbard et al. reported that, in women with a BMI ≥40, composite maternal morbidity (OR 1.9; 95% CI 1.5–2.6) and neonatal injury (OR 5.1; 95% CI 1.9–13.8) are more likely with TOLAC compared to elective repeat cesarean delivery.8 Similar to the data from McMahon and colleagues from the general population, the highest risk of morbidity was with failed TOLAC, highlighting the need to undertake TOLAC only if a patient has a reasonably high likelihood of success. Of note, according to the MFMU VBAC calculator, the patient in the case at the beginning of this article would have a 12.8% likelihood of de- CONTEMPOR ARY OB/GYN 25 PEER-REVIEWED livering vaginally. The morbidly obese woman without a prior cesarean delivery We know that morbid obesity is associated with an increased risk of labor induction, induction failure, and cesarean delivery.9-14 Because these outcomes are increased, obesity also is associated with increased risks of clinical chorioamnionitis, postpartum hemorrhage, wound infections, surgical complications, and increased neonatal morbidity (Figure 2).10,15-17 In addition, even lesser degrees of obesity (BMI 30–39) have been independently associated with postterm pregnancy, induction of labor, and cesarean delivery after postterm labor inductions.18-22 A randomized controlled trial would be the ideal study for comparing planned cesarean delivery to induction of labor for morbidly obese women who do not spontaneously labor. However, the feasibility of such a study is questionable at best. Data from recent studies Subramaniam et al. recently published a cohort study evaluating women with singleton pregnancies, a BMI ≥40, and delivery via either cesarean without labor or after labor induction. Sixty-five percent of the induction group had cervical ripening, and the cesarean delivery rate in the induction group was 41%. A composite of maternal morbidities occurred in 18.2% of the women who delivered vaginally after labor induction, 45.4% of those who had a cesarean delivery after an unsuccessful labor induction, and 24.4% who had a planned cesarean delivery without labor. After multivariable adjustments, 26 CONTEMPOR ARYOBGYN.NE T OBESITY maternal morbidity (aOR 0.98; 95% CI 0.55–1.77) was similar in women delivered by planned cesarean compared to the overall group delivered after inductions (both patients who delivered vaginally and those having a cesarean delivery after a failed induction).23 Neonatal morbidity followed a similar pattern—the neonatal morbidity composite occurred in 8.1% of the women who delivered vaginally after labor induction, 20.9% of those who had a cesarean delivery after an unsuccessful labor induction, and 10.3% who had a planned cesarean delivery without labor. After multivariable adjustments, neonatal morbidity (aOR 0.81; 95% CI 0.37–1.77) was similar in women delivered by planned cesarean delivery compared to the overall group delivered after labor inductions (both patients who delivered vaginally and those having a cesarean delivery after a failed induction).23 As expected, the group with the highest risks of both maternal and neonatal morbidity were patients who underwent cesarean delivery after an unsuccessful labor induction (aOR 3.7; 95% CI 2.4–5.9 for maternal and aOR 3.0; 95% CI 1.6–5.5 for neonatal morbidity). Using the same dataset, a cost minimization analysis showed that induction of labor in such patients is less costly than cesarean delivery without labor only if the chance of vaginal delivery is >57% (a cesarean delivery rate of <43%).24 Many subgroups of obese women have cesarean delivery rates in excess of 43%. Gunatilake et al. reported a 78% rate of cesarean delivery in women with a BMI ≥60.25 In a RCT of cervical ripening methods, Edwards et al. reported a 55% rate of cesarean delivery in women with a BMI ≥40 who Obesity Increased risks of: Labor induction Induction failure Cesarean delivery Increased risks of: Clinical chorioamnionitis Postpartum hemorrhage Wound infections Surgical complications Neonatal morbidity FIGURE 2 Labor induction, failure of labor induction, and cesarean delivery lead to increased rates of complications for the mother, fetus, and newborn. started labor inductions with the dinoprostone insert.26 More tools needed Previous cesarean delivery is a risk factor for placenta previa, placenta accreta, and hysterectomy in future pregnancies. Due to the fact that these complications are associated with previous cesarean delivery, the patient’s plans for future pregnancy should be considered when making decisions about delivery route. However, these complications are far less likely than the complications that drove the maternal morbidity composite in the above study by Subramaniam et al (puerperal infection, wound infection and/or disruption, postpartum hemorrhage, and hysterotomy extension).23 Until current trends reverse, clini- JUNE 2016 OBESITY cians will increasingly be faced with counseling morbidly obese women regarding their planned mode of delivery. In terms of morbidity risk, vaginal delivery is the preferred outcome for these women. However, cesarean delivery after labor is more morbid than cesarean delivery without labor. Providers need a calculator similar to the MFMU VBAC calculator that is capable of assigning a likelihood of vaginal delivery for morbidly obese women undergoing induction of labor. If the chance of vaginal delivery was sufficiently low using such a calculator, a primary cesarean delivery without a labor attempt would be less costly and would pose less risk to both mother and child. Development of such a calculator and evaluation of outcomes when patient care is guided by the results should be a research priority. REFERENCES 1. Vaginal birth after previous cesarean delivery. Practice Bulletin No. 115. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2010;116:450-463. 2. McMahon MJ, Luther ER, Bowes WA, et al. Comparison of a trial of labor with an elective second cesarean section. N Engl J Med. 1996;335:689-695. 3. Hamilton BE, Martin JA, Osterman MJK, et al. Births: Final data for 2014. National vital statistics reports; vol 64 no 12. Hyattsville, MD: National Center for Health Statistics. 2015. 4. Grobman WA, Lai Y, Landon MB, et al. Development of a nomogram for prediction of vaginal birth after cesarean delivery. Obstet Gynecol. 2007;109:806-812. 5. Chauhan SP, Magann EF, Carroll CS, Barrilleaux PS, Scardo JA, Martin JN. Mode of delivery for the morbidly obese with prior cesarean delivery: vaginal versus repeat cesarean section. Am J Obstet Gynecol. JUNE 2016 2001;185:349-354. 6. Carroll CS, Magann EF, Chauhan SP, Klaser CK, Morrison JC. Vaginal birth after cesarean section versus elective repeat cesarean delivery: weight-based outcomes. Am J Obstet Gynecol. 2003;188:1516-1522. 7. Edwards RK, Harnsberger DS, Johnson IM, Treloar RW, Cruz AC. Deciding on route of delivery for obese women with a prior cesarean. Am J Obstet Gynecol. 2003;189:385-390. 8. Hibbard JU, Gilbert S, Landon MB, et al. Trial of labor or repeat cesarean delivery in women with morbid obesity and previous cesarean delivery. Obstet Gynecol. 2006;108:125-133. 9. Baeten JM, Bukusi EA, Lambe M. Pregnancy complications and outcomes among overweight and obese nulliparous women. Am J Public Health. 2001;91:436-440. 10. Cedergren MI. Maternal morbid obesity and the risk of adverse pregnancy outcome. Obstet Gynecol. 2004;103:219-224. 11. Sebire NJ, Jolly M, Harris JP, et al. Maternal obesity and pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes Relat Metab Disord. 2001;25:1175-1182. 12. Weiss JL, Malone FD, Emig D, et al. Obesity, obstetric complications and cesarean delivery rate – a population-based screening study. FASTER Research Consortium. Am J Obstet Gynecol. 2004; 190:1091-1097. 13. Wolfe KB, Rossi RA, Warshak CR. The effect of maternal obesity on the rate of failed induction of labor. Am J Obstet Gynecol. 2011;205:128.e1-7. 14. Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009;114:1315-1321. 15. Scott-Pillai R, Spence D, Cardwell CR, Hunter A, Holmes VA. The impact of body mass index on maternal and neonatal outcomes: a retrospective study in a UK obstetric population, 2004-2011. BJOG. 2013;120:932-939. 16. Vermillion ST, Lamoutte C, Soper DE, Verdeja A. Wound infection after cesarean: PEER-REVIEWED effect of subcutaneous tissue thickness. Obstet Gynecol. 2000;95:923–926. 17. Owen J, Andrews WW. Wound complications after cesarean sections. Clin Obstet Gynecol. 1994;37:842–855. 18. Roos N, Sahlin L, Ekman-Ordeberg G, Kieler H, Stephansson O. Maternal risk factors for postterm pregnancy and cesarean delivery following labor induction. Acta Obstet Gynecol Scand. 2010; 89:1003-1010. 19. Athukorala C, Rumbold AR, Willson KJ, Crowther CA. The risk of adverse pregnancy outcomes in women who are overweight or obese. BMC Pregnancy Childbirth. 2010;10:56. 20. Suidan RS, Apuzzio JJ, Williams SF. Obesity, comorbidities, and the cesarean delivery rate. Am J Perinatol. 2012;29:623-628. 21. Gilead R, Yaniv Salem S, Sergienko R, Sheiner E. Maternal “isolated” obesity and obstetric complications. J Matern Fetal Neonatal Med. 2012;25:2579-2582. 22.+HUPDQQ0/H5D\&%ORQGHO%*RIÀQHW F, Zeitlin J. The risk of prelabor and intrapartum cesarean delivery among overweight and obese women: possible prevention actions. Am J Obstet Gynecol. 2015;212:241.e1-9. 23. Subramaniam A, Jauk VC, Goss AR, Alvarez MD, Reese C, Edwards RK. Mode of delivery in women with class III obesity: planned cesarean compared with induction of labor. Am J Obstet Gynecol. 2014;211:700.e1-9. 24. Subramaniam A, Corvey KJ, Kilgore ML, Edwards RK. Planned cesarean delivery compared to induction of labor in women with class III obesity: a cost-minimization analysis. J Matern Fetal Neonatal Med. 2015;1.5. [Epub ahead of print] 25. Gunatilake RP, Smrtka MP, Harris B, et al. Predictors of failed trial of labor among women with an extremely obese body mass index. Am J Obstet Gynecol. 2013;209:562.e1-5. 26. Edwards RK, Szychowski JM, Berger JL, et al. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014;123:1280-1287. CONTEMPOR ARY OB/GYN 27 PRACTICE MATTERS Lean and Six Sigma These process improvement strategies from the business world FDQEHXVHGHIIHFWLYHO\LQ\RXURIÀFH by THOMAS LEE, MD, MBA, AND THE ASSOCIATION FOR MATERNAL FETAL MEDICINE MANAGEMENT C linicians’ efforts to help our patients are increasingly being hampered by the global systems in which we practice. Metrics addressing quality, cost, and patient satisfaction often conflict with our desires for work-life balance, appropriate financial remuneration, and job satisfaction. Add to this the never-ending changes in healthcare reimbursement, billing and documentation requirements, and regulatory considerations, and it is not surprising that a majority of clinicians in the United States report flagging morale.1 Significant changes in how we practice medicine are urgently needed if we are to continue to provide compassionate, high-value care to our patients and their families within our current healthcare environment. While global healthcare reform may be beyond the scope of most clinicians, changing Changing how your practice operates will help you handle growing QUICK TAKE administrative mandates. Streamline processes and cut out waste to make the most of your patients’ time, your staff’s time and resources, and your own expertise. how one’s practice operates and addresses the aforementioned issues is something that is more realistic and achievable. How do we as front-line care providers bring about significant change within our practices without formal training? The unfortunate reality is that healthcare operations are not typically taught during medical training, yet have increasingly become a part of our professional lives. This article is a high-level, non-MBA primer on the concepts of Lean and Six Sigma process improvement techniques— concepts that may be increasingly referenced in your day-to-day admin- AMFMM’s mission is to create an environment that facilitates individual and organizational learning between managers and physicians that enriches the MFM patient experience while enhancing the MFM business value. 28 CONTEMPOR ARYOBGYN.NE T istrative discussions. The concepts of Lean and Six Sigma can be used by clinicians on the front lines to begin to change how their practices operate. Improving the efficiency of our office practices by working smarter and not necessarily harder can enhance the experiences of our patients, provide them with high-value care, and improve the financial performance of our organizations. Process improvement: The bigger picture Lean and Six Sigma do not stand alone. Rather, they are essential components of a global approach to workflow and DR LEE is a maternal-fetal medicine specialist at Northwest Perinatal Center Women’s Healthcare Associates, LLC, Portland, Oregon. +HKDVQRFRQÁLFWVRILQWHUHVWWRUHSRUWLQUHVSHFW to the content of this article. JUNE 2016 PRENATAL SCREENING LabCorp—along with Integrated Genetics, a member of LabCorp’s Specialty Testing Group—offers a prenatal screening portfolio that is unsurpassed. Our test options and genetic counselors provide you and your patients with information about your patients’ pregnancies. informaSeq Prenatal Test SM Provides your patients with a precise, noninvasive test that can assess risk for multiple fetal chromosomal aneuploidies from a single blood draw as early as 10 weeks for patients who meet certain criteria. The basic informaSeq test screens for T21, T18, and T13. Optional testing is also available for monosomy X, XXX, XXY, XYY, and fetal sex. Group B Streptococcus (GBS) Colonization Detection Next generation nucleic acid amplification testing offers improved sensitivity compared to culture1,2 for antepartum GBS screening between 35 to 37 weeks of gestation. We take a personal approach to laboratory testing. Comprehensive Carrier Screening One prenatal genetic screening visit can lead to many answers. The LabCorp comprehensive carrier screening test menu for inherited disorders provides high-quality and clinically relevant results for severe, early onset, or chronic disease. The menu includes CFplus®, which detects 97 clinically relevant mutations in a panethnic population, and Inheritest®, which is now available with expanded panels that use next-generation sequencing and analyze more than 7,400 mutations associated with more than 114 different inherited diseases. To learn more about the test options, visit www.LabCorp.com. ©2016 Laboratory Corporation of America® Holdings All rights reserved. 15290-0316#1 informaSeqSM Prenatal Test is Powered by Illumina® sequencing technology. informaSeqSM is a service mark of Laboratory Corporation of America® Holdings. Powered by Illumina® is a trademark of Illumina, Inc. in the US and/or other countries. CFplus® and Inheritest® are registered trademarks of Laboratory Corporation of America® Holdings. 1. Xpert® GBS LB [package insert]. Sunnyvale, CA: Cepheid; November 2012. 301-0576. 2. Montague NS, Cleary TJ, Martinez OV, Procop GW. Detection of group B streptococci in Lim broth by use of group B Streptococcus peptide nucleic acid fluorescent in situ hybridization and selective and nonselective agars. J Clin Microbiol. 2008 Oct;(46)10:3470-3472. PRACTICE MATTERS efficiency improvement. Table 1 is an example of a systematic approach to process improvement. Within this approach, Lean and Six Sigma reside within the “process improvement” phase. Standardization is the foundation for any process improvement initiative. Significant clinical variation is the enemy of efficiency. This is not to say that clinicians should not individualize care for select patients; however, the starting point for most patients should align with consensus-driven, evidence-based protocols. How to accomplish that is beyond the scope of this article, but progress on this issue needs to occur prior to addressing process efficiency. Lean TABLE 1 Components of an approach to improving process HIÀFLHQF\ CONTEMPOR ARYOBGYN.NE T Understand what you want to improve and where you Strategic plan want to end up Multidisciplinary project team Gather the right people to get you there Process improvement How you are going to get there Deployment Bringing it to fruition Reinforcement and reevaluation Making sure it works, making sure it sticks, and making it TABLE 2 better 7\SHVRIZDVWHLQKHDOWKFDUH Overproduction Lean production was initially developed by Taiichi Ohno at Toyota after World War II and originated from the company’s just-in-time production practices as part of the Toyota production system. The conceptual origins of Lean can be traced back through history, from the standardized manufacture of crossbows seen under the Chinese emperor Qin Shi Huangdi in 221 BC to the automobile production lines developed by Henry Ford.2 Lean is fundamentally based upon the philosophy of kaizen, Japanese for “improvement.” Kaizen involves employees at all levels working collectively toward incremental improvements. Since its introduction, the Lean production approach has been widely adopted in many commercial fields and it has also spread to healthcare. Lean’s kaizen objective is to create a seamless flow to the production process by reducing wasteful steps that contribute to inefficiency. Within the 30 LEAN AND SIX SIGMA 'HÀQLWLRQ Example Producing more than is Printing reports or labels when demanded or before it is they are not needed needed to meet demand Waiting Time during which value Providers waiting for a staff mem- is not being added to the ber or patient product or service Transportation Unnecessary travel of the Movement of patients or equip- product within the system ment from one area of the clinic to another Inventory Holding or purchasing Excess inventory of supplies and raw materials, work-in- pharmaceuticals SURFHVVDQGÀQLVKHG goods that are not immediately needed Motion Actions of operators that Unnecessary movement of the do not add value to the staff to obtain supplies product Overprocessing Unnecessary steps and Unnecessary EMR documentation procedures that do not add value to the service Defects Production of a part or Prescribing the incorrect medica- service that is scrapped tion to a patient or requires rework JUNE 2016 LEAN AND SIX SIGMA PRACTICE MATTERS FIGURE 1 SCHEMATIC OF VALUE STREAM MAPPING Six Sigma organizational infrastructure Process 2 Process 3 Process 4 Process 5 Cycle Time 1 Cycle Time 2 Cycle Time 3 Cycle Time 4 Cycle Time 5 Wait Time Wait Time Lean system, waste (known as muda) can take numerous forms (Table 2). When Lean process improvement is applied to healthcare, the steps involved in care delivery are individually examined as to whether they either 1) add value to the end goal, or 2) are wasteful and do not add value to the process. The ultimate goal of Lean process optimization is to eliminate those steps that do not add value to the delivery of care in your clinic— Wait Time leading to a more streamlined, efficient workflow.3 Many concepts and tools within the Lean lexicon of process optimization can assist in identifying and eliminating waste. The following are a few basic tools to consider using as you start to minimize inefficiency. Value-stream mapping Value-stream mapping is a powerful Lean tool that combines process map- Wait Time ping and time data into a single view (Figure 1). Value-stream mapping lists the individual steps within a process in order to identify value-added steps and non-value-added steps that contribute to the process cycle times (the time it takes your staff to complete a task) and their associated wait times (the time your patients wait in between). Value-stream mapping formally documents the tasks your staff mem- FIGURE 2 OB CLINIC EXAMPLE OF VALUE STREAM MAPPING Reception Type of appointment Look at schedule Change status to arrived Copy Ins, ODL, update demographics Scan all Print HIPAA and disclosures Collect copay Change status to checked in 1 min 8OWUDVRXQG Waiting Previous pt delayed Entering pt demographics Review medical records Patient is late Orders missing or incomplete AIDET Scan patient Fill out R4 and print report Change status Pt to waiting room Drop report at nurses’ station Finding LMP Status not changed Language barrier 9 min JUNE 2016 Retrieve pt from waiting room 36 min Waiting U/S behind schedule MA Retrieve pt from waiting room Grab report Abnormal U/S Pt stop at restroom Exam rooms full Take VS, meds, allergies No MA available Assess situation Awaiting report Teaching and handouts Waiting MA: provider not available Provider: Review or track down records Questions Status discrepancies EMR documentation Get report from MA Review medical records 9 min Do research Language barrier 10 min Physical exam Answer questions Discuss plan Review U/S, data Contact referring provider Reviewing report 3URYLGHU Discuss relevant problems and results 9 min 14 min Reception Pt walks up to check out Waiting MA back in: Education Blood draw Pt instructions Provider: Order labs Schedule test, procedure Call referring provider Check out: Missing orders Pt questions Language barrier Billing questions Identify orders Schedule pt Give appointment card Collect copay/balance if indicated 2 min 4 min CONTEMPOR ARY OB/GYN 31 PRACTICE MATTERS bers are performing as part of the chain of care. When these tasks and actions (ie, processes) are then viewed in conjunction with their associated cycle times and wait times in this format, it should initiate discussion and raise questions such as 1) What actually is the process in our office? 2) Why are there variations among our staff members? 3) Are all these steps necessary? and 4) How do these processes contribute to the cycle times and wait times? Once you start asking these questions, the targets for process efficiency frequently become readily apparent. One of the key benefits of valuestream mapping is that it helps to identify actual problems in the workflow, rather than relying on perceived anecdotal notions that you or your staff may have about clinic inefficiency. Furthermore, it allows you to understand what your staff is doing, what your patients are experiencing, and where improvements can be made. Spaghetti Diagrams Unnecessary movement is a significant type of muda. A spaghetti diagram is a visual depiction of the movement of staff, patients, and supplies within an office. The benefit of a spaghetti diagram is to first identify and then minimize wasted or redundant movement within the office workflow. Insights from a spaghetti diagram may lead you to change where supplies are placed, where staff workspaces are located, or even the design of the office layout. LEAN AND SIX SIGMA FIGURE 3 SPAGHETTI DIAGRAM OF OFFICE VISIT MOVEMENT DEXA Ultrasound Lab )URQWRIÀFH MA MD Supply Restroom Reception Exam Room Exam Room Patient Sonographer MD MA Procedure Room 5 Whys Technique Following a value-stream mapping exercise, a structured process called root-cause analysis is used to identify the factors that contribute to the non-value-added steps identified by the value-stream mapping. One type of root-cause analysis is the 5 Whys technique, which simply boils down to repeatedly asking the question “Why?” It is a way to peel away the layers of symptoms to uncover the root cause of a problem, since frequently the ostensible reason for a problem will lead you to another question.4 Usually about 5 rounds is a good rule of thumb. An advantage of the 5 Whys technique is that it is a simple tool that can be used without statistical analysis. Six Sigma Six Sigma was developed in the 1980s at Motorola as their in-house quality improvement initiative. The approach has since been adopted by many other organizations such as GE and IBM as part of their strategies to improve product and service quality. Six Sigma has also found a niche within many healthcare organizations as part of their quality improvement programs.5 The goal of Six Sigma is to eliminate defects by removing variance within manufacturing and business systems. In contrast to Lean, Six Sigma’s techniques for quality improvement place a much greater emphasis on data, statistical analysis, and mathematical modeling. In fact, the term six sigma SIX SIGMA HAS FOUND A NICHE WITHIN MANY HEALTHCARE ORGANIZATIONS AS PART OF THEIR QUALITY IMPROVEMENT PROGRAMS. 32 CONTEMPOR ARYOBGYN.NE T JUNE 2016 PRACTICE MATTERS LEAN AND SIX SIGMA methodology incorporates the use of a martial-arts-like hierarchical organizational infrastructure (Figure 4) along with specialized training and certification to define the roles that each person plays within the Six Sigma process. While formal Six Sigma certification and its statistical methodology may be beyond the scope of most practicing clinicians, several tools may be useful in your approach to process improvement. FIGURE 4 SIX SIGMA ORGANIZATIONAL INFRASTRUCTURE MOVEMENT Champions Master BB (1 for every 20 BBs) Black Belts (1-2%) Green Belts (5-10%) Yellow Belts (25-50%) comes from the mathematical concept that maintaining 6 standard deviations of variation within the confines of the process tolerance limits will nearly eliminate products that fail to meet required specifications (with the goal of no more than 3.4 defects per million opportunities). Formal Six Sigma The DMAIC Cycle A commonly used Six Sigma tool is the Define-Measure-Analyze-ImproveControl (DMAIC) cycle (Figure 5). The DMAIC cycle is composed of the following phases: 1. Define: understand the problem to be solved or the process to be improved. 2. Measure: understand how the current state is meeting the clinic’s requirements. 3. Analyze: examine collected data to determine the influential variables. 4. Improve: identify solutions and FIGURE 5 THE DMAIC CYCLE 'HÀQH Control Measure Improve Analyze implement. 5. Control: hardwire the changes to maintain the gains achieved. Using this series of steps as a roadmap allows your team to systematically gain an understanding of the process that you are trying to improve and work toward a sustainable solution. Seven Basic Quality Tools Six Sigma employs 7 basic quality conCONTINUED ON PAGE 41 FIGURE 7 FLOWCHART OF AN OFFICE VISIT Patient arrives and is checked-in by reception Reception QRWLÀHVVRQRJUDSKHU Sonographer escorts patient to ultrasound Pelvic ultrasound exam performed MA obtains vital signs & reviews history MA escorts patient to exam room Sonographer QRWLÀHV0$ Patient escorted to waiting room MA reports to provider Provider sees patient for exam and endo bx Patient directed to reception to schedule visit Follow-up visit scheduled and patient released JUNE 2016 CONTEMPOR ARY OB/GYN 33 ACOG GUIDELINES AT A GLANCE EXPERT PERSPECTIVES ON PRACTICE BULLETINS COMMITTEE ON PRACTICE BULLETINS—OBSTETRICS Practice Bulletin No. 154: Operative Vaginal Delivery. November 2015 (Replaces Bulletin No. 17, June 2000). American College of Obstetricians and Gynecologists. Obstet Gynecol. 2015;126:e56-65. Full text of ACOG Practice Bulletin available to ACOG members at http://www.acog.org/Resources_And_Publications/Practice_Bulletins/Committee_on_Practice_Bulletins_--_Obstetrics/Operative_Vaginal_Delivery. OPERATIVE VAGINAL DELIVERY Despite significant or vacuum extractor requires that an obstetrician and obstet- changes in management of labor and delivery over the past ric care provider be familiar with the proper use of the instru- few decades, operative vaginal delivery remains an impor- ments and the risks involved. The purpose of this document is tant component of modern labor management, accounting to provide a review of the current evidence regarding the ben- for 3.30% of all deliveries in 2013 (1). Use of obstetric forceps efits and risks of operative vaginal delivery. Used with permission. Copyright the American College of Obstetricians and Gynecologists. COMMENTARY Operative vaginal delivery: a lost art by CHARLES J LOCKWOOD, MD, MHCM Dr Lockwood is Senior Vice President, USF Health and Dean, Morsani College of Medicine, University of South Florida, Tampa, and Editor in Chief of Contemporary OB/GYN. When I was a resident I performed more than 250 operative vaginal deliveries, mostly with forceps, and many after rotation. I suspect many practitioners of my generation compiled similar numbers during their training. Well, times have changed. Whereas in 1990 slightly more than 9% of livebirths resulted from either forceps delivery (5.11%) or vacuum extraction (3.9%), by 2014 only 3.21% of livebirths resulted from operative vaginal delivery and forceps accounted for less than 20% of these births (0.57% of all live births).1 The latest ACOG Practice Bulletin 34 CONTEMPOR ARYOBGYN.NE T on this subject serves as an excellent summary of the indications, prerequisites, advantages, and overall safety of this increasingly lost art.2 Operative vaginal delivery is indicated for both maternal and fetal reasons. The former include exhaustion and ineffectual pushing in the second stage of labor as well as various medical and obstetrical factors requiring an expedited second stage. Such factors include preexisting cardiovascular disease, deteriorating medical conditions (eg, hypertension, sepsis), prolonged second stage of labor, arrest of descent or the need to rotate the fetal head to effect vaginal delivery. In cases of nonreassuring fetal heart rate (FHR) tracings, operative vaginal delivery may not only obviate the short- and long-term maternal morbidities of cesarean delivery but avoid progressive fetal ischemia. While the Practice Bulletin retains the traditional classification system for outlet, low and mid-forceps deliveries (see Box 2), ACOG points out that in general, the lower the fetal head in the pelvis and the less rotation required, the less the risk of maternal and fetal injury. Vaginal birth is more likely to be achieved with forceps than with vacuum extraction, but the former has about twice the rate of associated 3rd- or 4th-degree perineal tears. However, despite this higher rate of perineal trauma, when compared with outcomes for cesarean delivery, forceps delivery was not associated with higher rates of pelvic floor or sexual dysfunction in primiparous women 1 year postpartum.3 In addition, no differences in bowel or bladder function were found between women delivered by forceps versus vacuum extraction at 5 years.4 JUNE 2016 Bio-Oil® is a skincare oil that helps improve the appearance of scars, stretch marks and uneven skin tone. It contains natural oils, vitamins and the breakthrough ingredient PurCellin Oil™. For comprehensive product information please visit biooilhealth.com. Bio-Oil is the No.1 selling scar and stretch mark product in 18 countries. $11.99 (2fl.oz). ACOG GUIDELINES The Practice Bulletin does caution against the routine use of episiotomy with operative vaginal delivery given its association with perineal trauma. Forceps delivery has been associated with fetal facial lacerations and nerve palsy, ocular trauma, skull fractures and intracranial hemorrhage, while vacuum extraction has been linked to fetal scalp lacerations, cephalohematoma formation, subgaleal and retinal hemorrhage. Fortunately, all these risks are low. While neurological complications occur in 1 of 220 to 385 infants having operative vaginal deliveries, these rates must be compared OPERATIVE VAGINAL DELIVERY This study found that the absolute risk of neonatal mortality from intracranial hemorrhage was 3 to 4 per 10,000 for both instruments. Long-term neurological outcomes also appear comparable among infants delivered spontaneously versus by operative vaginal delivery.7 The Practice Bulletin also addresses the contentious issue of operative vaginal delivery of the macrosomic infant. The authors note that the risk of persistent injury is comparable between macrosomic infants who were delivered spontaneously compared with operative vaginal delivery, suggesting THE PRACTICE BULLETIN ALSO ADDRESSES THE CONTENTIOUS ISSUE OF OPERATIVE VAGINAL DELIVERY OF THE MACROSOMIC INFANT. to those delivered by, often emergent, cesarean section. For example, using seizure, intraventricular hemorrhage, and subdural hemorrhage as collective indicators of adverse neurologic outcome, forceps deliveries were associated with a reduced risk of such outcomes compared with both vacuum extraction (odds ratio 0.60; 95% CI: 0.40-0.90) and cesarean delivery (OR 0.68; 95% CI: 0.48-0.97).5 Similarly, while vacuum deliveries were associated with higher rates of scalp laceration, fracture, and brachial plexus injury compared with cesarean, they were not associated with excess neurological injury. Indeed, Walsh and associates noted that when compared with cesarean delivery in the 2nd stage of labor, operative vaginal delivery accrued similar rates of neonatal death and encephalopathy.6 36 CONTEMPOR ARYOBGYN.NE T that it is the macrosomia rather than the mode of vaginal delivery which is the culprit. The Practice Bulletin concludes that “judicious use of operative vaginal delivery for infants with suspected macrosomia is not contraindicated.” The authors do point out that the adequacy of the pelvis and the progress of labor, especially the 2nd stage, should be carefully considered in this setting and preparations made for a possible shoulder dystocia. Among the recommendations made by ACOG are: r0QFSBUJWFWBHJOBMEFMJWFSZJTDPOtraindicated if the fetal head is unengaged or its position is unknown, or if a fetal demineralizing or bleeding condition is suspected; and it should be performed only by experienced obstetricians with the appropriate hospital privileges. r 8IJMF DFTBSFBO EFMJWFSZ BGUFS “failed” operative vaginal delivery in the setting of a nonreassuring FHR tracing is associated with increased neonatal morbidity, this risk must be weighed against the benefits of an expedited delivery when operative vaginal delivery is successful in this setting. On balance, ACOG prudently opines that “A trial of operative vaginal delivery is an appropriate option [when] the obstetrician [...] feels the chances of success are high, but must be prepared to abandon the attempt if appropriate descent does not occur.” r#FDBVTFPGJODSFNFOUBMGFUBMBOE maternal risk, sequential use of vacuum extraction and forceps or vice versus should not be routinely performed. r 8IJMF UIF SJTL PG DFQIBMPIFNBtoma increases with the duration of vacuum application, particularly after 5 minutes, release of vacuum pressure between contractions does not appear to be associated with improved outcomes. r 'PSDFQT SPUBUJPOT UP FŀFDU EFMJWery are not linked to excess neonatal neurological morbidity. Furthermore, because forceps rotation of a fetus in a persistent occiput posterior position to an occiput anterior position may reduce maternal perineal laceration, it seems reasonable to attempt manual or forceps rotation of fetuses in certain such circumstances. r7BDVVNFYUSBDUJPOJTEJTDPVSBHFE at gestational ages less than 34 weeks. r /FPOBUBM QSPWJEFST TIPVME CF made aware of an operative vaginal delivery to facilitate observation for related complications. FOR REFERENCES VISIT contemporaryobgyn.net/ACOG-PB154 JUNE 2016 FIRST PERSON OBSTETRICS Get a handle on the Scanzoni maneuver This forceps-aided rotation can be used when the fetus is occiput posterior and the head is low in the pelvis. by SARAH CIGNA, MD, MS; NANCY D GABA, MD; AND JOHN W LARSEN, JR, MD For this technique, we use Tucker-McLane forceps with Luikart Clinical scenario Your patient has had a long, slow labor, with pain predominantly in her back (the infamous “back labor”). She is now fully dilated and the head has progressed well into the pelvis, but it is not crowning, and you find that the patient’s exam is notable for right occiput posterior (OP) position. The patient is exhausted. She has tried a number physical maneuvers and labor positions with minimal progress. Manual rotation of the head was unsuccessful. The choice at this point is to move to a cesarean delivery or to try a Scanzoni rotation to turn the head with forceps with physicians aiding the rotation abdominally. A cesarean delivery is less desirable in this case as the head is wedged down deep in the pelvis. JUNE 2016 QUICK TAKE PRGLÀFDWLRQEHFDXVHWKH\UHVXOWLQIHZHULQMXULHVWRWKHIHWDOIDFLDOVNLQ The angle of the shanks in relation to the maternal spine is crucial. A ZLGHDQJOHUHVXOWVLQDSSURSULDWHWRUTXHDQGPDLQWDLQVÁH[LRQRIWKHIHWDO neck throughout rotation. History The Scanzoni maneuver was invented by Friedrich Wilhelm Scanzoni, a German obstetrician, in 1849. His method for changing a posterior presentation into an anterior one required the use of forceps twice in the process of delivery.1 Context OP positions are the most common type of malposition, cited to comprise between 1% and 5%.2 They are often accompanied by some degree of deflexion, resulting in a larger presenting diameter. The presence of asynclitism and molding can make it difficult to correctly determine position, leading to an inaccurate diagnosis of occiput anterior (Figure 1). Risk factors for OP position include smaller pelvic outlet capacity, prior OP, nulliparity, maternal age >35, gestational age ≥41 weeks, birth weight >4000 g, artificial rupture of the membranes (AROM), and epidural anesthesia.3 OP position as a cause DR CIGNA is a resident DR GABA is DR LARSEN is Professor of Obstetrics physician in the Department Professor and Chair and Gynecology at The George of Obstetrics and of the Department of Washington University, Washington, DC. Gynecology, The George Obstetrics at The George 1RQHRIWKHDXWKRUVKDVDFRQÁLFWRI Washington University Washington University, interest to report in respect to the content Hospital, Washington, DC. Washington, DC. of this article. CONTEMPOR ARY OB/GYN 37 FIRST PERSON OBSTETRICS for persistent labor dystocia can be corrected using the Scanzoni method, allowing successful vaginal delivery. Maternal Anterior Forceps “False” posterior fontanel True position is ROP False perception of position is LOA Maternal Posterior FIGURE 1 Black outline: fetal head in true right occiput posterior position. Gray RXWOLQHGHSLFWVWKHFRPPRQO\PLVWDNHQLGHQWLÀFDWLRQRIWKHSRVWHULRURFFLSXW DVOHIWRFFLSXWDQWHULRUHVSHFLDOO\LQFDVHVZLWKVLJQLÀFDQWPROGLQJ forceps with Luikart modification for ease of application and find that they result in fewer injuries to the fetal facial skin. Technique Overlapping shanks corrects asynclitism FIGURE 2A Correction of asynclitism with articulation of the forcep shanks. 38 CONTEMPOR ARYOBGYN.NE T For successful completion of the Scanzoni maneuver, the patient should be in the dorsal lithotomy position. To begin, the forceps are applied to the head in the usual fashion, with the posterior blade placed first, and the anterior blade second. The blades should be oriented with their pelvic curve aligned to the curve of the maternal sacrum, as with any forceps placement. The blades are then articulated so that they overlap and the handles squeezed together to lock the blades in place around the head which corrects the asynclitism (Figure 2A). The next portion of this maneuver is initiated by using the forceps to flex the fetal neck and dislodge the malpresenting cranium. The shanks of the forceps should be directed in a wide arc beginning between 12- and 3-o’clock, and ending at 6 o’clock, essentially “screwing out” the head with the natural forces of contraction as well as laterally directed pressure on the abdomen applied by an assistant (Figure 2B 1,2). The lateral pressure serves to rotate the shoulder simultaneously with the head. The angle of JUNE 2016 ILLUSTRATION BY ALEX BAKER, DNA ILLUSTRATIONS, INC. Our preferred forceps to use for Scanzoni rotation are Tucker-McLane, in this case with the Luikart modification. Tucker-McLane forceps feature solid rather than fenestrated blades. The Luikart modification is a pseudofenestration. Most importantly, unlike the Simpson forceps blades with their widely separated shanks, the shanks of the Tucker-McLane forceps are overlapping. This decreases the risk of a tear during the wide rotation when correcting the position of the head. An article by W Barth, MD, recently published in Obstetrics & Gynecology, described rotational forceps using the Kielland forceps followed by Simpson forceps for traction and delivery.4 We find that the Scanzoni maneuver is preferable to facilitate successful delivery of a persistently OP baby. We favor the solid pseudofenestrated blades of the Tucker-McLane FIRST PERSON OBSTETRICS 1. Flexion of neck 2. Rotation of head in wide arc FIGURE 2B After correction of asynclitism (depicted by solid outline forceps), WKHKHDGLVÁH[HGE\DQJOLQJWKHIRUFHSVXQWLOSDUDOOHOWRWKHPDWHUQDOOHIW thigh and then rotated in a wide arc until the head is in occiput anterior position (shown as progressively darker dotted outline). ILLUSTRATION BY ALEX BAKER, DNA ILLUSTRATIONS, INC. the shanks in relation to the maternal spine is crucial. The shanks should be oriented almost vertically, perpendicular to the maternal spine, almost parallel to the maternal thighs in the dorsal lithotomy position. It is this wide angle that gives the operator an appropriate amount of torque and more importantly, maintains flexion of the fetal neck throughout rotation. Once rotation is complete, the blades must be switched in order to realign them with the maternal pelvic curve. This is easiest if done between contractions (Figure 2C). Removal and replacement of the forceps should be done following the curve of the blades, as in any forceps maneuver. The blade that is now posterior can be removed and replaced inside the anterior blade. The anterior blade is then removed and replaced posteriorly. Keeping one blade in place at all times will splint the head in its rotated position, preventing reversal of rotational progress. Finally, the forceps can be rearticulated and used to guide the head out to crowning station (Figure 2D). At this point the blades should be removed and the head and body delivered with maternal effort to avoid unnecessary trauma to the perineum. Management of the third stage of labor can proceed in a standard fashion. REFERENCES 1. Merriam-Webster.com. Scanzoni Maneuver. http://www.merriam-webster.com/medical/scanzoni%20maneuver. Accessed April 20, 2015. 2. Sizer AR, Nirmal DM. Occipitoposterior position: associated factors and obstetric outcome in nulliparas. Obstet Gynecol. 2000;96(5):749–752. 3. Cheng YW, Shaffer BL, Caughey AB. Associated factors and outcomes of persistent occiput posterior position: A retrospective cohort study from 1976 to 2001. J Matern Fetal Neonatal Med. t in2006;19(9):563–568. 4. Barth W. Persistent occiput posterior. Obstet Gynecol. 2015;125(3):695–709. Head guided to crowning station Reapplication of forceps between contrations FIGURE 2C Rotation of head is maintained during reapplication of the forceps by keeping one blade in place at all times. JUNE 2016 Figure 2D Head is guided to crowning station with usual low forceps delivery technique. CONTEMPOR ARY OB/GYN 39 LEGALLY SPEAKING OB/GYN VERDICTS AND SETTLEMENTS Did induction cause this uterine rupture? CONTINUED FROM PAGE 48 Although no episiotomy was needed, some second-degree tears were immediately repaired. The plaintiff experienced postpartum hemorrhage, which Dr B diagnosed as uterine atony because the uterus was boggy and soft. Oxytocin was administered at about 9:19 pm to treat the atony and hemorrhage. plaintiff’s uterus, although she would have to deliver any future children via cesarean. Following the successful surgery, Dr B informed the plaintiff that she had never heard of dinoprostone causing uterine rupture. Resident doctors likewise told the plaintiff that a uterine rupture is not a common occurrence. THE DINOPROSTONE CAUSED THE UTERINE RUPTURE AND THAT THE DEFENDANTS THEY CLAIMED THAT DEVIATED FROM THE STANDARD OF CARE. The plaintiff was given an injection of methylergonovine at about 9:45 pm, also to treat the atony and hemorrhage. When the methylergonovine appeared ineffective, Dr B ordered 400 mg of misoprostol, half the usual dose, to be administered rectally. The bleeding ceased and the plaintiff appeared to be recovering until approximately 10:55 pm, when she experienced pain, dizziness, and vomiting. Dr B ordered fluids and attempted to determine the cause of the plaintiff’s symptoms. A bedside ultrasound was inconclusive, but a second ultrasound revealed fluid around the uterus. Dr B took the plaintiff to the operating room to perform an exploratory laparotomy, where she discovered that the plaintiff had sustained a 10-cm posterior uterine rupture. She undertook the repair and saved the 40 CONTEMPOR ARYOBGYN.NE T $OOHJDWLRQV The plaintiff’s lawyer claimed that the defendants did not appropriately monitor the plaintiff after the insertion of the dinoprostone and negligently prescribed dinoprostone, misoprostil, and oxytocin to induce labor. They claimed that the dinoprostone caused the uterine rupture and that the defendants deviated from the standard of care in failing to perform serial vaginal examinations of the patient and in ordering dinoprostone and oxytocin after the delivery in an to attempt to control bleeding. They also contended that misoprostol was not utilized for its Food and Drug Administration-approved purpose. 'LVFRYHU\ Dr B testified that her plan was to use the dinoprostone to start induction and “prevent [the plaintiff ] from getting chorioamniotis, sepsis, and ending up with a C-section,” she said. She further testified, “ … the plan is always with somebody who has such an unfavorable cervix and ruptured membranes is to use a cervical ripening agent in the hopes that we will be able to start Pitocin augmentation with a better outcome.” According to Dr B, in a patient such as the plaintiff, who tested positive for GBS and had ruptured membranes, the most pressing concern is to prevent infection, and that is why dinoprostone was used. As for the perforation, despite such a rupture being, in her words, “a major adverse event, a really, really rare thing” often requiring hysterectomy, Dr B was able to successfully repair the rupture, and as she said, “save her life, save her uterus.” The plaintiff recalled that Dr B “told me that she didn’t expect to check me until I got the Pitocin, unless I wanted an epidural.” She claimed that “immediately” upon the insertion of dinoprostone she began experiencing lower abdominal pain and this precipitated the 2 pm request for an epidural. The plaintiff acknowledged that the doctors at the hospital all told her that she “almost died,” saying, “it’s a miracle that you’re still here.” The plaintiff’s husband likewise thanked Dr B “so much,” saying, “I thought she was going to die. You saved her life.” The plaintiff performed Internet “research” and found that “a uterine rupture is an adverse effect of Cervidil, and that the patient should be monitored for pain, as pain is not really common with Cervidil and pain JUNE 2016 LEGALLY SPEAKING OB/GYN VERDICTS AND SETTLEMENTS is an indication that something might be going wrong with the Cervidil.” 5HVROXWLRQ Armed with expert support, we moved for summary judgment dismissing all claims. Our ob expert opined that the plaintiff’s assertions regarding use of misoprotsol and oxytocin “during labor” lacked merit and they were used after labor. She stated that the patient was an appropriate candidate for dinoprostone given that there was no cervical dilatation or active labor for 7 1/2 hours after her water broke. It was good practice to remove the dinoprostone only when the patient went into active labor and to avoid vaginal examinations given her GBS status. There was no evidence either of uterine hyperstimulation or of dinoprostone causing or contributing to uterine rupture in this prima gravida. In opposing the motion to dismiss, the plaintiff’s expert argued that the defendants departed from good practice in failing to remove the dinoprostone in the face of hyperstimulation and active labor. They claimed a failure to perform vaginal exams during 7 hours of labor and that dinoprostone “on rare occasions” can cause rupture in a “pristine” or unscarred uterus. In reply, we submitted literature on uterine rupture with concomitant dinoprostone use that did not recognize dinoprostone as a causal factor in rupture of a pristine uterus. We also challenged the opposing expert’s LEAN AND SIX SIGMA CONTINUED FROM PAGE 33 trol tools to help maintain consistency of products and services. These tools were first popularized by Kauro Ishikawa, who believed that up to 95% of quality-related problems could be addressed with these fundamental tools.3 r 'JTICPOF EJBHSBN B DBVTFBOE effect tool useful in root-cause analysis (Figure 6, online) r $IFDL TIFFU B DVTUPN EBUB DPMlection form to track quantitative and qualitative data on problems and defects in real time r )JTUPHSBN B HSBQI UP JMMVTUSBUF probability or frequency distributions r 1BSFUP DIBSU B TPSUFE IJTUPHSBN that focuses on the most influential factors; based upon the Pareto principle that 80% of costs, issues, or defects can be attributed to 20% of the items JUNE 2016 being measured r'MPXDIBSUBQSPDFTTNBQ'JHVSF r 4DBUUFS QMPU B HSBQI PG UIF SFMBtionship between 2 factors, suggesting either causation or correlation r3VODIBSUBDISPOPMPHJDQMPUPGB process metric, useful in examining trends Best of both worlds Much of how all this business theory applies to healthcare may be overwhelming to a clinician or practice manager who does not have formal training in Lean or Six Sigma. The 2 approaches overlap substantially, and many organizations have advocated the use of Lean and Six Sigma philosophies and tools in tandem as what is known as Lean Six Sigma. In this author’s opinion, the combined Lean diagnosis of tachysystole as inconsistent with the record. 7KHYHUGLFW The court granted our moWLRQIRUGLVPLVVDOÀQGLQJWKDW although the plaintiff’s expert created a question of fact as to when the patient went into active labor, he was unable to meet his burden of proof with regard to the use of dinoprostone being a departure from good practice or causing the rupture at issue. PRACTICE MATTERS Six Sigma approach is better for use within healthcare because it brings together the goals of Lean’s reduction of waste and Six Sigma’s reduction of process variability. Figure 8 is a conceptual illustration of how these 2 systems can be used together in the clinical realm. Imagine that points A and B represent the beginning and end of a clinical process such as seeing a patient for a LEEP. The steps involved in completing the procedure are represented by each oval (eg, check-in, notifying the MA, reviewing the chart and indications, setting up the procedure room, retrieving the patient, notifying the MD, etc.). Each step in the process is characterized by an “amplitude” that represents the variability for that specific CONTINUED ON PAGE 42 CONTEMPOR ARY OB/GYN 41 PRACTICE MATTERS CONTINUED FROM PAGE 41 step, since each staff member is likely to have a slightly different way of completing that task. In order to improve efficiency, Lean techniques can be used to eliminate wasteful (or non-value-added) steps and thereby reduce the overall length of the process. Six Sigma techniques can also be brought to bear on the process to reduce the workflow variation among staff members (through work standardization), which is represented by a reduction in the amplitude of the step. The end result is a more streamlined, less wasteful workflow for performing the LEEP, which is the ultimate goal of your efficiency improvement efforts. 6XPPDU\ Lean and Six Sigma systems contain a wealth of tools and techniques that can be used to improve the quality and efficiency of your practice. Having a general understanding of the differences between Lean and Six Sigma along with how they can also work in synergy is the first step in getting started. Remember though that these tools do not stand alone and should be incorporated into a sequential approach that starts with development of an organizational strategic plan and a multidisciplinary process improvement team. Folding a DMAIC structure, value-stream mapping, and root-cause analyses into the efficiency improvement process comes later. However, knowledge of the tools you will have available when that time comes should give you confidence in taking that first step. With a good roadmap and the right tools, the goals of providing higher-value healthcare, increased patient and provider satisfaction, and improved 42 CONTEMPOR ARYOBGYN.NE T LEAN AND SIX SIGMA FIGURE 8 CONCEPTUAL ILLUSTRATION OF LEAN SIX SIGMA B A A A financial performance are attainable for providers and offices on the front lines of care delivery. Resources are available for those who are inspired to rise to the challenge. REFERENCES 1. Ray W, Norbeck T. Survey of 20,000 physicians reports morale still low, but slightly improving. Forbes (2014 Oct 3). Retrieved February 14, 2016 from http://www.forbes.com/ sites/physiciansfoundation/2014/10/03/survey-of-20000-physicians-reports-morale-stilllow-but-slightly-improving/#3304cd2724d5 2. Hunt B. The history and simplicity of Lean process improvement. Process Excellence Network (2009 July 7). Retrieved February 14, 2016 from http://www.processexcellencenetwork.com/lean-six-sigma-business-transformation/articles/the-history-and-simplicity-oflean-process-improve/ 3. McLaughlin DB, Olson JR. Healthcare operations management, 2nd ed. Chicago, IL: Health Administration Press; 2012. 4. iSixSigma. (2015). Determine the Root Cause: 5 Whys. Retrieved July 2, 2015, from http://www.isixsigma.com/tools-templates/ cause-effect/determine-root-cause-5-whys/ B B LEAN SIX SIGMA 5. Bandyopadhyay JK, Coppens K. Six Sigma approach to healthcare quality and productivity management. Int J Productivity and Quality Management. 2005;5(1):V1-V12. SUGGESTED RESOURCES Cohen F, Dahl O. Lean Six Sigma for the medical practice: Improving profitability by improving processes. Phoenix, MD: Greenbranch Publishing; 2010. Lighter DE. Basics of health care performance improvement: A Lean Six Sigma approach. Burlington, MA: Jones & Bartlett Learning; 2013. McLaughlin DB, Olson JR. Healthcare operations management, 2nd ed. Chicago, IL: Health Administration Press; 2012. Suneja A, Suneja C. Lean doctors. Milwaukee, WI: American Society for Quality, Quality Press; 2010. JUNE 2016 2016 Annual Meeting The Science and Art of Menopause Health Marriott Gaylord Palms Hotel Orlando, Florida October 5-8, 2016 The Continuing Education program will cover these topics: Q Q Q Q Q Q Q Q Q Q Q Cardiovascular Disease Risk Assessment Controversies in the Medical Management of DCIS Hormone Therapy and Nonhormonal Management of Menopause Symptoms Osteoporosis Risk and Treatment Options The Evolution of Desire Vulvar and Vaginal Health The History and Basic Science of Soy Isoflavonoids Nutritional Needs for the Midlife Woman Flibanserin—Are We Evening the Score? The Natural History of Menopause Symptoms And much more Pre-Meeting Symposium Menopause and the Brain: Maximizing Cognitive and Psychological Well-being at Midlife Presentations will address mood changes, screening and treatment of depression and anxiety, cognitive changes and complaints, and sleep, with interactive panel discussions. For More Information www.menopause.org/2016-scientific-program 308 MARKETPLACE For Products & Services Advertising, contact: Joanna Shippoli (800) 225-4569 ext. 2615, [email protected] FEMININE HYGIENE A BETTER PERIOD EXPERIENCE! Enjoy 12 hour leak-free protection, comfort and convenience with The DivaCup. EDUCATE YOUR PATIENTS Order your FREE Resource Demo Kit today at divacup.com/resource divacup.com SEMINARS SPACE TO SHARE BURBANK CA ObGyn in solo practice seeks another ObGyn to share office space, office rent and night calls Contact: [email protected] Reach your target audience. Our audience. Contact me today to place your ad. Repeating an ad ENSURES it will be seen and remembered! 44 CONTEMPOR ARYOBGYN.NE T Joanna Shippoli Account Manager 440-891-2615 [email protected] JUNE 2016 For Recruitment Advertising, contact: Joanna Shippoli (800) 225-4569 ext. 2615, [email protected] CAREERS CALIFORNIA NATIONAL Get a Life... OBSTETRICS/GYNECOLOGY PHYSICIAN Olive View-UCLA Medical Center, a Los Angeles County facility and major teaching hospital for the David Geffen School of Medicine at UCLA, is recruiting a full-time BC/BE general obstetrician/ gynecologist. We are seeking individuals who will contribute to an academic, energetic and creative multidisciplinary faculty. Responsibilities include direct patient care with strong emphasis on mentoring and training residents in the UCLA Ob/Gyn Residency Program, as well as the teaching of medical students. Opportunities in clinical and basic science research are available and encouraged. Employment includes an academic appointment at the David Geffen School of Medicine at UCLA. Competitive salary and benefits provided. Applicants at the level of Assistant or Associate Professor will be considered. This is an excellent opportunity in sunny Southern California for interested academicians. Applicant must be eligible for licensure in California. EOE …follow your passion Play a pivotal role in improving the health of women ĂŶĚďĂďŝĞƐŶĂƟŽŶǁŝĚĞ^ĞĞLJŽƵƌƐĞůĨƉƌĂĐƟĐŝŶŐƚŚĞ ŵĞĚŝĐŝŶĞLJŽƵĚĞƐŝƌĞĂŶĚůŝǀŝŶŐƚŚĞůŝĨĞLJŽƵĚĞƐĞƌǀĞ In 2016, OBHG celebrates 10 years of ĞůĞǀĂƟŶŐƚŚĞ ƐƚĂŶĚĂƌĚŽĨǁŽŵĞŶƐŚĞĂůƚŚĐĂƌĞKƵƌƚĞĂŵŝŶĐůƵĚĞƐ more than 450 skilled physicians who serve a network of nearly 100 hospitals in ϮϱƐƚĂƚĞƐŶĂƟŽŶǁŝĚĞ Please submit letter of intent, CV, and three references to: Dr. Christine Holschneider Chair, Department of Obstetrics and Gynecology Olive View- UCLA Medical Center 14445 Olive View Drive, 6D-116 Sylmar, CA, 91342 Fax: (818) 364-3255 Email: [email protected] www.OBHG.com INDIANA %NKPKE OBGYN OPPORTUNITY t t t t t t Each physician has a consistent nurse with the addition of a few float nurses Average of 25 – 35 clinic patients per day Clinic Hours: Monday – Friday 9:00 am – 5:00 pm – No Weekends Approximately 1 – 1.5 clinic days dedicated to OB and 2 – 2.5 clinic days dedicated to GYN patients Average work week is 4 – 4.5 days per week Clinic is divided into blocks of OB patients and blocks of GYN patients by full or half day increments 1RRQTVWPKV[ Schneck Medical Center is seeking a Board %GTVKƂGF'NKIKDNG1$);0 to join their established traditional OB/GYN Practice. t t t t 5EJPGEM/GFKECN%GPVGT is one of the most w>V>ÞÃÌ>LiëÌ>Ã`>>>` `i«i`iÌÞÜi`>`«iÀ>Ìi`° t t t t Physician is leaving practice to move back to Montana Will see patients from existing patient base and new patients Hospital employed position Practice has an impeccable reputation - represented by their 80% market share in home county and growing market share in surrounding counties Physicians have similar training and work extremely well together $80,000 Sign-on Bonus, $2,500/month stipend, Salaried Position 304 PTO hours per year + 24 CME PTO hours per year $2,500 per year CME allowance + $1,000 electronic/educational material allowance Centrally Located in Southern Indiana Seymour, Indiana is located just off Interstate 65 in the southern part of the state. Seymour is a one hour drive from Indianapolis, Louisville, and Bloomington, home of Indiana University, and only 90 minutes from Cincinnati. A city of tree-lined streets, beautifully restored historical homes, and quaint shops, yet close to the cultural and entertainment amenities of the bigger cities. Excellent school system offering both public and parochial education options. Thriving manufacturing industry helps promote low unemployment and a robust economy. FOR CONTACT INFO USE : Fayeann Hurley,1IZTJDJBO3FDSVJUFSt4DIOFDL.FEJDBM$FOUFStPGmDFt')VSMFZ!TDIOFDLNFEPSH Place a recruitment ad in Contemporary OB/GYN. JUNE 2016 CONTEMPOR ARY OB/GYN 45 CAREERS ILLINOIS OSF Saint Francis Medical Center – Peoria, IL Opportunity for a Physician to join our OB/GYN Hospitalist team slated to begin at OSF Saint Francis Medical Center in Peoria, IL. The ideal candidate will be board-certified in OB/GYN (MD or DO), be able to demonstrate clinical excellence with superior communication skills, and have a focus on providing quality care placing the patient above all other considerations. Qualifications also include active and current skills in the full breadth of the OB/ GYN specialty, a current Illinois license to practice or near the end of the licensure process. Other requirements include a willingness to drive patient safety and quality initiatives as required by the TeamHealth Patient Safety Organization, insurability for malpractice insurance, at least 2 years of active practice, and a successful track record. TeamHealth offers competitive compensation plus paid professional liability insurance with tail coverage. Narrow your candidate search to the best. Place a recruitment ad in Contemporary OB/GYN. Joanna Shippoli National Account Manager, Healthcare Careers (440) 891-4569 | [email protected] To learn more about these or other Hospital Medicine opportunities, contact Jonathan Goldsmith at 954.377.3081 or [email protected], or visit www.teamhealth.com. MASSACHUSETTS A well-established, full-scope community Ob/Gyn practice is seeking a full-time BC/BE physician to join their busy and growing practice. This practice includes MD’s, CNM’s and NP’s with a large experienced VXSSRUWVWDII:LWKLQRXUSUDFWLFHDQGLQRI¿FHZHRIIHURQVLWHSURFHGXUHV state of the art 3D ultrasound, maternal fetal medicine consults, Level II ultrasound as well as a minimally invasive trained gyn surgeon. Our EHDXWLIXOXSVFDOHPDLQRI¿FHLVORFDWHGRQWKHKRVSLWDOFDPSXVZLWKWKUHH VDWHOOLWHRI¿FHVVHHLQJSDWLHQWVDVZHOO+RVSLWDORIIHUVKRXULQKRXVH anesthesia and pediatric coverage. The hospital maintains strong clinical collaborations with Boston’s academic centers ensuring that physicians have access to world-class resources. UTAH Intermountain is frequently referenced nationally as one of the leaders in delivering high quality/low cost healthcare. Intermountain Healthcare needs OB/GYN’s in multiple cities throughout Utah. Contact: Physician Recruiting, 800-888-3134, [email protected], http://physicianjobsutah.org VIRGINIA :-6+-2-% -RHITIRHIRX3&+=2TVEGXMGISJ1(´WERH;,24´WMWWIIOMRK ER3&+=2TL]WMGMERXSTVEGXMGIMRXLI8MHI[EXIVEVIEQMRYXIW JVSQXLIFIEGL'EPP'SQTIXMXMZIWEPEV]ERHFIRI½XW 4PIEWIIQEMP':XSKF$KVIIRFVMIVSFLVGS\QEMPGSQ Recent grads welcome. 3DFNDJH RIIHUV D FRPSHWLWLYH VDODU\ ZLWK FDOO FRYHUDJH %HQH¿WV LQFOXGH PDOSUDFWLFH LQVXUDQFH KHDOWK GHQWDO . ZHHNV YDFDWLRQ ZHHN&0(DQGDGD\ZRUNZHHN Enjoy everything that New England has to offer with this beautiful and FRQYHQLHQWORFDWLRQOHVVWKDQPLQXWHVIURP%RVWRQ7KLVSLFWXUHVTXH community is home to some of the best schools in Massachusetts and provides endless opportunities for cultural, recreational and historical activities. Please email [email protected] CLASSIFIEDS WORKS! 46 CONTEMPOR ARYOBGYN.NE T Expert Advice for Today’s Ob/Gyn Content Licensing for Every Marketing Strategy Leverage branded content from Contemporary OB/GYN to create a more powerful and sophisticated statement about your product, service, or company in your next marketing campaign. Contact Wright’s Media to find out more about how we can customize your acknowledgements and recognitions to enhance your marketing strategies. For information, call Wright’s Media at 877.652.5295 or visit our website at www.wrightsmedia.com JUNE 2016 CAREERS Expert Advice for Today’s Ob/Gyn Content Licensing for Every Marketing Strategy Marketing solutions fit for: Outdoor | Direct Mail | Print Advertising | Tradeshow/POP Displays | Social Media | Radio & TV Logo Licensing | Reprints | Eprints | Plaques Leverage branded content from Contemporary OB/GYN to create a more powerful and sophisticated statement about your product, service, or company in your next marketing campaign. Contact Wright’s Media to find out more about how we can customize your acknowledgements and recognitions to enhance your marketing strategies. For more information, call Wright’s Media at 877.652.5295 or visit our website at www.wrightsmedia.com ADVERTISER INDEX Companies featured in this issue To obtain additional information about products and services advertised in this issue, use the contact information below. This index is provided as an additional service. The publisher does not assume any liability for errors or omissions. FERRING PHARMACEUTICALS CERVIDIL ................................... 12-14 www.cervidil7.com HOLOGIC NOVASURE ...................................... 5 www.novasure.com THINPREP ................................ CV2-1 www.thinprep.co LABCORP CANCER RISK AND SCREENING .. 3 www.labcorp.com PRENATAL SCREENING ............... 29 www.labcorp.com JUNE 2016 LUMENIS FEMTOUCH.................................... 23 www.lumenis.com NIGHTLIGHT CHRISTIAN SNOWFLAKES EMBRYO ADOPTION ....................... COVERTIP www.Nightlight.org THE NORTH AMERICAN MENOPAUSE SOCIETY (NAMS) NAMS ANNUAL MEETING ............ 43 PACIFIC WORLD BIO-OIL ........................................... 35 ZZZSDFLÀFZRUOGFRP QIAGEN SCIENCES AMNISURE .................................. CV4 www.qiagen.com THERAPEUTICS MD VITAPEARL ..................................... 19 www.vitaMedMDRx.com www.menopause.org ONSITE MAMMOGRAPHY ONSITE MAMMOGRAPHY .............. 9 www.ONsiteMammography.com CONTEMPOR ARY OB/GYN 47 LEGALLY SPEAKING by ANDREW I. KAPLAN, ESQ Did induction cause this uterine rupture? A case hinges on the plaintiff’s lawyers claim of departure from good practice. I n September 2011, a woman learned she was pregnant with her first child and visited ob/gyn Dr A. At some point during the pregnancy, Dr A diagnosed fibroids and indicated that if they grew too large, the patient would need to deliver via cesarean. In the early morning of April 29, 2012, the patient’s water broke and her husband brought her to the hospital at approximately 4 am. The patient—the plaintiff in this case— was at 35 weeks’ gestation. Dr A had an agreement with defendant ob Dr B to cover each other’s patients, and it was Dr. B who was the attending physician managing the plaintiff ’s care when she arrived at the hospital. At the time, Dr B was the director of ambulatory care as well. The plaintiff was examined by a resident upon arrival at 4 am and was next seen by Dr B at about 5:30 am. Because the plaintiff had tested positive for Group-B streptococcus (GBS), Dr B ordered prophylactic antibiotics and indicated that the plaintiff would need to be admitted. At approximately 11:00 am, Dr B examined the woman and indicated she would be placing dinoprostone to prepare the plaintiff ’s nonfavorable cervix for oxytocin administration later. Dr B then informed the residents of the examination and placement of plaintiff to any further infection, Dr B had instructed that she should be examined only if there was tachysystole, a FHR tracing abnormality, or active labor. From approximately 3 pm until 7 pm, the plaintiff was having contrac- THE PLAINTIFF VAGINALLY DELIVERED A HEALTHY GIRL WITH APGARS OF 9/9. the dinoprostone and said that the plaintiff could receive an epidural if she complained of pain. At around 2 pm, the plaintiff complained of pain and an epidural was administered. Throughout the day, the labor and delivery nurses monitored the plaintiff, checking the fetal heart rate (FHR) monitor and palpating as necessary at 2:30, 4:05, and 5:43. In addition, the residents periodically assessed the plaintiff, but did not perform a vaginal examination as they were directed not to do so by Dr B because of the plaintiff ’s GBS status. Specifically, to prevent exposing the tions every 2 to 4 minutes, the FHR tracings were reassuring, and the plaintiff was not experiencing pain. Thus, there was no need to conduct a vaginal examination. When the plaintiff was examined by a resident later that evening, the dinoprostone was found “on the chux.” No other induction agent was used and by 8:30 pm, plaintiff was fully dilated and began to push. At 9:16 pm, the plaintiff vaginally delivered a healthy girl with Apgars of 9/9. FOR MORE LEGALLY SPEAKING TURN TO PAGE 40 Andrew I Kaplan, Esq is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP in New York City, specializing in medical malpractice defense and healthcare litigation. 48 CONTEMPOR ARYOBGYN.NE T JUNE 2016 Published as a supplement to PUBLISHED AS A SUPPLEMENT TO X MAY 2016 X PREDICTING sPTB EARLY: WHAT DO WE DO NOW? MODERATOR: KIM BOGGESS, MD Professor of OBGYN, University of North Carolina Dr. Boggess has researched and published extensively on the pathophysiology of preterm birth, contributing to recognition of maternal infection and periodontal disease as causative factors. She was a principal investi- Proceedings of a panel discussion hosted by Sera Prognostics at the 2016 Society of Maternal-Fetal Medicine Annual meeting. gator in the PAPR study. » These two proteins were used in an algorithm which is the ratio of the relative expression levels of two proteins—the ratio of IBP4 over SHBG. This ratio defines a score used to predict the probability of subsequent preterm birth. » Dr. Saade reviewed the performance of these two proteins measured at 19 or 20 weeks of pregnancy as described in the following chart from the paper: AUC P-VALUE OR (95% C) <35 VS >35 0.93 0.00092 34.5 (1.7-698.9) <37 VS >37 .75 .016 5.0 (1.4-18.0) PANELISTS: MATTHEW K. HOFFMAN, MD MPH Vice Chairman, Department of OBGYN and the Division of Education and Research, Christiana Care Health System (left to right) Jay Boniface, PhD, John Zupancic, MD, Scott Sullivan, MD, Matt Hoffman, MD and Kim Boggess, MD, discuss the opportunities and issues related to early prediction of preterm birth at the 2016 meeting of the Society of Maternal-Fetal Medicine in Atlanta, GA. X INTRODUCTION <TWQI\NIJ UWJYJWR GNWYM 59' IJąSJI FXIJQN[JW^GJKTWJ\JJPXLJXYFYNTSWJRFNSXFSJSTWRTZXXTHNJYFQUWTGQJRæNYèX YMJRTXYKWJVZJSYHFZXJTKSJTSFYFQIJFYM FSIYMJXJHTSIQJFINSLHFZXJTKIJFYMKTW HMNQIWJS FLJI ! ^JFWX <J MF[J RFIJ UWTLWJXXæNS YMJ :8 UWJYJWR GNWYM WFYJWJFHMJIFSJ\QT\TK 'ZYYMJWJ NXRTWJ\TWPYTGJITSJYTWJIZHJ59'FSI NYXHTRUQNHFYNTSX © Sera Prognostics 2016 <NYM YMJ YTTQX F[FNQFGQJ YT ZX YTIF^ UM^XNHNFSXFWJZSFGQJYTUWJINHYYMJQFWLJRFOTWNY^TK\TRJS\MT\NQQJ[JSYZFQQ^IJQN[JW UWJYJWR 3T\ \J MF[J F UWTYJTRNH UWJINHYTWå\MNHMFQXTUWT[NIJXYMJGJLNSSNSL TKLWJFYJWZSIJWXYFSINSLTKUFYM\F^X 9MJ TGOJHYN[J TK YMNX INXHZXXNTS NX YT QTTP FY XTRJ TK YMJ NRUQNHFYNTSX TK MF[NSL FS TGOJHYN[JUWJINHYTW<MFYIT\JITINKKJWJSYQ^$.S\MFY\F^XHFSYMNXRFPJFLWJFYJW INKKJWJSHJ NS TZW ąLMY FLFNSXY UWJYJWR GNWYM$<JFQXTSJJIYTFIIWJXXXTRJTKYMJ ZSHJWYFNSYNJX YMFY J]NXY \MJS \J PST\ F \TRFSNXFYWNXPKTWUWJYJWRGNWYM 2^YMFSPXYTYMJUFSJQNXYXKTWYMJNWNSXNLMY FSIHTSYWNGZYNTSYTYMJINXHZXXNTS Kim Bog gess, MD SCIENTIFIC OVERVIEW OF THE PRETRM® TEST FOR RISK MANAGEMENT & THE PAPR STUDY BOGGESS: Jay, will you give us an overview of the clinical and scientific aspects of the PAPR (Proteomic Assessment of Preterm Risk) study? BONIFACE: Let me begin this discussion by reviewing some of the highlights of the presentation on the PAPR study given at the SMFM Oral Plenary session by Dr. George Saade (University of Texas Medical Branch). 2 ABOUT THE PAPR STUDY: » A large, prospective clinical study of 5501 patients. » Patients were enrolled across 11 sites in the U.S. » The participants were representative broadly of the U.S. population according to race, ethnicity, and geography. » Serum samples were drawn from women between 17 to 28 weeks of pregnancy with the intent to identify biomarkers in serum that would be predictive of women who subsequently experienced a spontaneous preterm birth (sPTB), defined as birth before 37 weeks gestation. » Two proteins were identified that were highly predictive of preterm birth and can be measured in maternal serum: › Insulin-like Growth Factor Binding Protein 4 (IBP4) › Sex Hormone Binding Globulin (SHBG) Content and funding provided by Sera Prognostics Dr. Hoffman is an experienced investigator in OBGYN research; he is involved in trials nationally and internationally for the prevention of preterm birth. Dr. Hoffman was an investigator in the PAPR study. The PreTRM Test was developed based on this data; now the physician and the patient can know her individualized risk of preterm birth. The test can be performed as early as 19 weeks through 20 weeks, 6 days. We identified this optimal period as where the test was most predictive. In the future, with continued analysis of these proteins and their trajectories through a patient’s pregnancy, it may be possible to potentially approximate gestational age at birth. SCOTT SULLIVAN, MD, MSCR Director, Division of Maternal Fetal Medicine, Medical University of South Carolina; Professor, Medical University of South Carolina Dr. Sullivan is interested in preterm birth prevention, OB surgery techniques and the evaluation of health disparities and quality health indicators. Dr. Sullivan was an investigator in the PAPR study. JOHN ZUPANCIC, MD, MS, SCD Associate Chief of Neonatology, Beth Israel Deaconess Medical Center; Associate Professor of Pediatrics, Harvard Medical School Dr. Zupancic is a neonatologist and health economist focusing on performing and improving the validity of economic evaluations, and an expert in the use of computer modeling to determine best practice when there’s no current evidence or studies are not possible. JAY BONIFACE, PHD Chief Scientific Officer, Sera Prognostics Dr. Boniface led the discovery, verification and validation process for the PreTRM test. His training is in the area of protein biochemistry, biophysics and molecular immunology. › Fetal Growth Restriction › Androgenic & Estrogenic Steroid Levels › Placental Growth › Stress › Nutrient Uptake › Inflammation The majority of preterm births may be explained by a model that postulates that pregnancies associated with infection/inflammation or placental insufficiency would be expected to result in suppressed SHBG or elevated IBP4 levels, respectively. CLINICAL IMPLICATIONS OF AN OBJECTIVE PREDICTOR OF PRETERM BIRTH BOGGESS: Matt and Scott, could you discuss what you think the implications are of having this information clinically as you see women in your practice? HOFFMAN: First, let me state that we have a great history of examining protein expression in obstetrics to predict risk. One example is the quad screen, that by examining proteins that are differentially expressed in a specific time frame, we can meaningfully assess the risk of a pregnancy being affected by Down syndrome. This is not a novel model for obstetrics. Regarding prematurity, when we look at the cost and implications on obstetrical care, prematurity remains our primary challenge. Meaningful change has not been made as of yet. This is in large part due to the fact that until recently, we have been unable to reliably identify which women are at risk. Now that we have the PreTRM test, what do you do with the results and how do we make this clinically meaningful? Content and funding provided by Sera Prognostics Predicting sPTB Early: What Do We Do Now? A panel discussion on spontaneous preterm birth hosted by Sera Prognostics read it now at contemporaryobgyn.net/sera-sptb based on physical examination alone (1). And traditional diagnostic methods* carry a combined negative predictive value (NPV) of 54.5% (2). AmniSure is a 98.9% sensitive, 98.1% specific test for PROM. AmniSure can be run within 10-15 minutes and does not require a speculum exam (3). To learn more, visit www.AmniSure.com *ph/nitrazine, ferning, pooling. Trademarks: QIAGEN®, Sample to Insight®, AmniSure® (QIAGEN Group). PROM-9498-001 03/16 1101407 © 2016 QIAGEN, all rights reserved. Sample to Insight Membranes) Test Instructions for Use. QIAGEN, 2015. Membrane (PROM) cases, the diagnosis is uncertain E.R., Kim, K.W., Park, H.S., Jun, J.K. (2007) Measurement of placental a-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet. Gynecol. 109, 634–40. AmniSure ROM (Rupture of [fetal] In nearly half of all suspected Premature Rupture of References: 1. Neil, P.R.L. and Wallace, E.M. (2010) Is AmniSure useful in the management of women with prelabour rupture of the membranes? Aust. N. Z. J. Obstet. Gynaecol. 50, 534–8., 2. Lee, S.E., Park, J.S., Norwitz, Your answer can impact a life. Evaluate PROM confidently by including AmniSure.®
