Download Comparing Harms of Vaginal and Cesarean Birth: Maternity

Comparing Harms of Vaginal and Cesarean Birth:
Maternity Center Association’s Systematic Review
& Education & Quality Improvement Campaign
Carol Sakala, PhD, MSPH
Maureen P. Corry, MPH
Maternity Center Association
June 2005
[Maternity Center Association’s name changed to Childbirth Connection on 1/1/2006.
All documents referenced in these slides are available through Childbirth Connection’s
redesigned expanded website at http://www.childbirthconnection.org.
Speaking points are available in Notes view.
Download source for this file:
http://www.childbirthconnection.org/article.asp?ck=10271&ClickedLink=200&area=2
2006 Childbirth Connection. All rights reserved.]
Maternity Center Association (MCA)
Improving maternity care since 1918
Key audiences: childbearing women, health
professionals
Evidence-based maternity care focus, 1999www.maternitywise.org
Maternity Center Association
Mission
To promote safe, effective and satisfying
maternity care for all women and their families
through research, education and advocacy
Maternity Center Association
Major Program Areas
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Maternity Wise® website
Listening to Mothers® Initiative
Labor Pain Initiative
Labor Support Initiative
Cesarean Alert Initiative
See many related resources at www.maternitywise.org
Context for Decision to Focus on
Cesarean Section
Rapid Shifts in Belief, Including New Ideas
“Vaginal birth is harmful.”
“Vaginal birth is causing pelvic floor problems, after birth and
later in life.”
“Having a cesarean will prevent later life pelvic floor problems.”
“The benefit/harm ratio is shifting to equipoise or now favors
cesarean.”
“Cesarean delivery, especially elective cesarean, is safe.”
Context for Decision to Focus on
Cesarean Section (cont)
Rapid Shifts in Practice
• cesarean rate rising exponentially (est. 30% or higher now)
• cesarean rate rising for all indications, all populations
• new indications for cesarean
• increased use of planned elective cesarean and labor
cesareans without indication*
• vaginal, VBAC, instrumental rates falling off
* Declercq et al, BMJ (2005); Kalish et al. Obstetrics & Gynecology
(2004);Declercq et al., American Journal of Public Health (in press)
Context for Decision to Focus on
Cesarean Section (cont)
Rapid Change Without Benefit of a
Systematic Look at the Evidence
• some systematic reviews for specific indications (e.g.,
previous cesarean)
• no attempt to understand full range of harms that differ
• “narrative” reviews generally appear to make case for or
against casual/liberal use of cesarean
• narrative reviews are unreliable!
Context for Decision to Focus on
Cesarean Section (cont)
ACOG Committee on Ethics, 2003 Committee Opinion
“Surgery and Patient Choice”
“The ethical evaluation is clouded by the limitations of data
regarding relative short- and long-term risks and benefits of
cesarean versus vaginal delivery.”
“If the physician believes that [elective] cesarean delivery
promotes the overall health and welfare of the woman and her
fetus more than vaginal birth, he or she is ethically justified in
performing a cesarean delivery.”
Context for Decision to Focus on
Cesarean Section (cont)
Confusion and Controversy Among Professionals
Professionals divided, uncertain how to help pregnant women
make sense of the issues
Large practice variation for many indications: gray areas that
could benefit from better understanding of associated harms
Large practice variation across hospitals: NYC 2002 hospital
cesarean rates ranged from 10% to 37% (see
www.choicesinchildbirth.org)
Context for Decision to Focus on
Cesarean Section (cont)
Confusion and Controversy Among Women,
General Public
Media coverage incomplete, misleading, potentially
inaccurate
Informed consent, and informed refusal, not possible
without full and accurate information
MCA’s Plan in Response
• Invite participation of multi-disciplinary
partners
• Carry out systematic review
• Develop brochure to help inform pregnant
women about the issues
• Plan media outreach about review results and
availability of brochure
• Plan online resources for women
Partnership
Invitations sent to national non-profits in the field, to
participate in one or more ways:
• provide feedback on initial proposal
• send relevant documents that group has prepared
• provide feedback on review document and draft brochure
• consider endorsing revised brochure
• consider participating in media outreach
Many groups participated in one or (mostly) multiple
ways
Partnership (cont)
Review and booklet reflect input and support from:
• obstetricians
• family physicians
• pediatricians
• midwives
• nurses
• childbirth educators
• doulas
• researchers
• advocates
• consumers
Multidisciplinary = high-quality products, exciting
process
Systematic Review Protocol
Scope
Focus on comparing harms (benefits depend upon
specific indications and may be well understood
through available sources)
Core question: what adverse outcomes differ
between cesarean and vaginal birth?
Consider various comparisons, as harms may vary:
• cesarean or vaginal overall
• planned or unplanned cesarean
• spontaneous or instrumental vaginal birth
Systematic Review Protocol
Scope (cont)
What Outcomes to Include?
Anything “clinically relevant” or “mother relevant” –
what mothers may want to know about:
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maternal and infant/child
shorter- or longer-term
physical and mental health
mother-baby relationship, attachment, breastfeeding
Exclude surrogate markers, as we don’t know what
they mean for lives of mothers, babies
Systematic Review Protocol
Process
Use Oxford Centre for Evidence-based Medicine
Research Grading System
Include best identified research in review
• Level 1: rarely available for review questions
• Level 2 and/or 3: best identified and included evidence for
most outcomes; better quality observational studies and
systematic reviews of observational studies
• Level 4: include only when nothing else found
• Level 5 (incl. narrative reviews): lowest, exclude
www.cebm.net/levels_of_evidence.asp
Additional Review Questions
What is the relationship between mode of delivery
and pelvic floor dysfunction?
What factors contribute to pelvic floor dysfunction?
• method of delivery
• other obstetric practices
• maternal and fetal factors
• non-obstetric factors
Important for women: understand factors contributing
to pelvic floor problems, especially modifiable ones
Additional Review Question
In light of very broad practice variation and
uncertainty about optimal rates:
Do high rates of cesarean or instrumental birth
confer benefits relative to more conservative use?
Challenge:
Balancing Needs Against Resources
Large agenda
• series of relevant and interrelated questions
• many potential outcomes that may differ by method of
delivery and be important to women
Belief and practice shifting very rapidly
Finite resources and no external funding in hand
Solution:
Balancing Needs Against Resources
Apply Guidelines to Limit Scope of Work
Identify series of recent narrative reviews by respected leaders
with diverse conclusions
Limit studies for possible inclusion to
• citations in these narrative reviews
• citations in draft of closely related UK National Institute for
Clinical Excellence Review
• 2 MEDLINE searches for most current material
• searches in 2 databases of systematic reviews
• abstracts/articles on file with MCA
• English language
Solution (cont):
Balancing Needs Against Resources
MCA had initiated dialogue with Agency for
Healthcare Research and Quality (AHRQ) about
need for full evidence report on these matters
through their Evidence-based Practice program
MCA would continue this dialogue
Systematic Review, in Summary:
Limiting Bias, Having Credible Results
Established guidelines in advance
Made them transparent, and adhered to them
Scrupulously used these criteria and not study results to
decide whether to include or exclude a study
Summarized results of included studies
Unique contribution: goal of full accounting of differences
in harm achieved by validated systematic procedures
Results Overall
Over 300 research reports evaluated for inclusion in
review, described in evidence tables
Included studies described dozens outcomes related to
key review questions, which were incorporated into an
outline of key questions
Outline of questions and outcomes used as framework for
developing evidence tables with details of studies
Results Overall (cont)
PDF files available online:
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methods and sources document
outline of questions and outcomes
full evidence tables
summary of results for professionals
See www.maternitywise.org/prof/cesarean/
In preparation:
• manuscripts for professional journals
Results Overall (cont)
Many adverse effects appear to differ by mode of delivery
Overall, results strongly favor vaginal birth
Vaginal instrumental delivery associated with series of
adverse effects (could limit harm by avoiding episiotomy
and offering cesarean late vs. difficult instrumental birth)
Overall, spontaneous vaginal birth is associated with fewest
harms
Consumer booklet, results summary for professionals, and
manuscripts report absolute risk differences when
available through included studies
Shorter-term Harms of Cesarean to
Mothers
In comparison with vaginal birth, increased harm
due to:
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death, related to surgery or anesthesia (rare)
emergency hysterectomy
blood clots and stroke
injuries from surgery
longer hospitalization
rehospitalization
infection
severe and long-lasting pain
Social & Emotional Harms of
Cesarean to Mothers
In comparison with vaginal birth, increased harm due
to:
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poor birth experience
less early contact with baby
early unfavorable reaction to baby
psychological trauma (unplanned cesarean)
depression??
poor overall mental health and self-esteem
poor overall functioning
Ongoing Physical Harms of Cesarean
to Mothers
In comparison with vaginal birth, increased harm due
to:
• ongoing pelvic pain
• bowel obstruction
(due to scar tissue and adhesions)
Harms of Cesarean to Babies
In comparison with vaginal birth, increased harm due
to:
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accidental cuts during surgery
mild to severe respiratory problems
not initiating breastfeeding
asthma, in childhood and adulthood
Harms of Cesarean to
Mothers in Future Pregnancies
In comparison with vaginal birth, increased harms
due to:
• infertility – involuntary
• infertility – voluntary
• ectopic pregnancy/cesarean scar pregnancy
Harms of Cesarean to Mothers in
Future Pregnancies (cont)
In comparison with vaginal birth,
increased harms due to:
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placenta previa
placenta accreta
placental abruption
uterine rupture
maternal death
Harms of Cesarean to Babies in
Future Pregnancies
In comparison with vaginal birth, increased harms
due to:
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death, before or shortly after birth
low birth weight and preterm birth
malformation
central nervous system injury
Informed Choice and Distant Harms
Virtually Universal Disclosure Essential
Average parity is low and many women do not intend to be
pregnant again, but
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many change their minds
many decide to continue with unintended pregnancies
primary cesarean rate is rising
access to VBAC is declining
Special concern for high-parity populations
Disclosure essential unless a woman cannot become
pregnant in future (e.g., having tubal ligation)
Are Planned Cesareans
(Before Labor) the Answer?
Some advantages relative to
unplanned cesareans:
• less short-term surgical injury
• less emotional toll
Are Planned Cesareans
(Before Labor) the Answer? (cont)
Planned cesarean is still major surgery
• excess short-term surgical harms relative to vaginal birth
• conditions associated with scarring and adhesions (these
harms likely to be similar to unplanned cesareans)
• all future fertility and pregnancy risks associated with
uterine scar (these harms likely to be similar to unplanned
cesarean)
• potential for iatrogenic respiratory problems in babies
Harms of Assisted Vaginal Birth
to Mothers
In comparison with spontaneous vaginal birth,
increased harms due to:
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3rd and 4th degree perineal tears
excessive bleeding and transfusion
rehospitalization
Infection
Adverse impact of midline
painful perineum
episiotomy co-intervention
urinary incontinence
appears to be substantial
any bowel problems
for this set of outcomes
bowel incontinence
Harms of Assisted Vaginal Birth
to Mothers (cont)
In comparison with spontaneous vaginal birth,
increased harms due to:
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poor birth experience
psychological trauma (traumatic symptoms, PTSD)
sexual problems (pain, frequency, satisfaction)
poor overall functioning/prolonged recovery
Harms of Assisted Vaginal Birth
to Mothers (cont)
To limit adverse effects of assisted delivery:
• maintain assisted delivery skills
• avoid routine episiotomy co-intervention
• offer cesarean if and when clear that assisted delivery will
be difficult
Excellent recent SOGC guidelines available at:
sogc.medical.org/SOGCnet/sogc_docs/common/guide/library_e.shtml#obstetrics
Harms of Assisted Vaginal Birth
to Babies
In comparison with spontaneous vaginal birth,
increased harm due to:
• brain injury
• brachial plexus injury
Harm of Vaginal Birth*
to Babies
In comparison with cesarean, increased harm
due to:
• brachial plexus injury
* spontaneous or overall
Harms of Vaginal Birth*
to Mothers
In comparison with cesarean, increased harms
due to:
• perineal pain
• any urinary incontinence
• any bowel incontinence
* spontaneous or overall
Problem of Overly Broad
Definitions of Incontinence
Urinary
• may include any or minimal incontinence, at any point
(e.g., “drop or 2”)
Bowel
• may include any leaking gas, any leaking feces, or any
urgency without leakage, at any point
Need to focus on
• actual concerns and experiences of women
• impact on women’s quality of life
• degree to which any problems persist after recovery
period
Problem of Use of
Surrogate Markers
Uncertain whether group differences in physiologic
measurements have any practical meaning for women’s
symptoms and quality of life and, if so, the duration
Inappropriate to use these studies to guide practice and
policy
Problem of Co-Interventions that
Contribute to Pelvic Floor Dysfunction
Practices associated with pelvic floor injury:
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episiotomy
instrumental delivery
pushing in supine or lithotomy position
forceful, directed pushing
fundal pressure
perineal pressure
Problem of Co-Interventions (cont)
Many women experience several with vaginal birth
Liberal or routine use is not evidence-based practice
Large practice variation (e.g., 2002 episiotomy rates
across NYC hospitals: 1% to 88% of vaginal births)*
Potential to reduce much harm with conservative
practice style and judicious use
* www.choicesinchildbirth.org
Relationship Between Vaginal Birth
and Pelvic Floor Dysfunction
We did not find a single study that attempted to minimize or
control for harmful co-interventions to try to understand whether
giving birth through the vagina increases risk of pelvic floor
problems
Inappropriate at this time to state that “vaginal birth”
causes pelvic floor dysfunction
Given current knowledge
• imperative to improve management of vaginal birth
• inappropriate to promote cesarean as preventive measure
Relationship Between Vaginal Birth
and Pelvic Floor Dysfunction (cont)
We must do a better job:
Understanding the scope of problems
Understanding causes of problems
• maternity factors (which ones?)
• non-maternity factors (modifiable?)
Reducing risk through improvements in vaginal birth
management practices
Understanding and applying non-invasive prevention
and treatment strategies (e.g., Kegels)
Incontinence Results with Usual Care
Incontinence after vaginal birth:
• infrequent for most who experience it
• minimal to mild severity for most
• falls off sharply during recovery period
A year after vaginal birth:
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about 3% have any new-onset urinary incontinence
about 3% have any new-onset anal incontinence
severe and troubling problems rare
severe urinary or anal incontinence due primarily to
combined forceps with episiotomy
Incontinence Results with Usual Care:
Longer Term
Vaginal Birth and Later-life Incontinence?
• incontinence problems arising at birth diminish over time
• differences between cesarean and vaginal groups for
urinary & bowel incontinence disappear by about age 50
• high rates of later-life incontinence associated with other
factors
Non-Maternity Factors Associated with
Incontinence
Excess weight
Smoking
HRT
Hysterectomy
Urinary tract infections
Some chronic diseases
Some medications
Impaired mobility
Genetics
Many impact large numbers of women
Many are modifiable
Life Course Perspective
Need to sort timing of onset of notable problems:
• before pregnancy
• during pregnancy
• after postpartum period
Vaginal birth cannot cause, cesarean cannot prevent
Increasingly common popular and professional
presumption that vaginal birth is associated with
any pelvic floor dysfunction: flawed
Practice Variation:
Price for Lower Intervention Rates?
Over 25 studies examined practice variation for
rates of:
• cesarean section
• instrumental vaginal birth
• episiotomy
No evidence of adverse effects in mothers
and babies with conservative care
But challenging to fully account for possible
differences in risk
Review Conclusion:
Safest Way to Give Birth
Without clear, compelling and well-supported
justification for cesarean section or assisted
vaginal birth, a spontaneous vaginal birth
minimizing use of interventions that may be
injurious to mothers and babies is the safest way
for women to give birth and babies to be born.
Myth and Reality
Myth:
Cesarean section is safe
Reality:
Vaginal birth is far safer overall for mothers and
babies
Although cesarean section is safer than in the
past, it is major abdominal surgery and poses
many extra harms for mothers and babies in
comparison with vaginal birth
Myth and Reality (cont)
Myth:
Planned cesarean is on optimal solution for
mothers and babies
Reality:
Vaginal birth is far safer overall for mothers and
babies
Planned cesarean is very convenient for busy
hospitals and caregivers
Myth and Reality (cont)
Myth:
Vaginal birth is harmful for mothers and babies
Reality:
Vaginal birth is far safer overall for mothers and
babies than cesarean section
Some overused medical practices during vaginal
birth are harmful to mothers and babies
Research has not been done to determine whether
giving birth through the vagina has intrinsic risks in
comparison with cesarean section
Myth and Reality (cont)
Myth:
Having an elective cesarean section will prevent
incontinence later in life
Reality:
Current research suggests that having a cesarean
section will have no effect on incontinence later in
life
Having an elective cesarean section poses many
harms and limited benefit to mothers and babies
Evidence Into Education, Advocacy:
Tips for Reducing Risk
Overall Tips: Pregnancy
Find doctor or midwife with low rates of intervention
Discuss goals & preferences with caregiver
Choose birth setting with low rates of intervention
Create your own birth statement
Arrange for continuous labor support
Explore options for pain relief
Evidence Into Education, Advocacy:
Tips for Reducing Risk (cont)
Overall Tips: Labor
Work with caregivers to delay going to hospital
Receive good support throughout labor
If possible, avoid continuous EFM
Avoid epidural analgesia
Evidence Into Education, Advocacy:
Tips for Reducing Risk (cont)
Tips for Avoiding Unnecessary Cesareans: Pregnancy
If cesarean proposed, make informed decision
If had previous cesarean, make informed decision
If baby is breech, make informed decision
If you fear vaginal birth, consider in-depth counseling
Evidence Into Education, Advocacy:
Tips for Reducing Risk (cont)
Tips for Avoiding Unnecessary Cesareans: Labor
Avoid routine interventions when possible (in addition
to EFM, epidural: induction, AROM, arbitrary time
limits)
If a cesarean is proposed, make informed decision
Evidence Into Education, Advocacy:
Tips for Reducing Risk (cont)
Tips for Avoiding Unnecessary Assisted Birth:
Labor
Push in an upright or side-lying position
Avoid time limits for pushing
Let your body guide pushing, when possible
Evidence Into Education, Advocacy:
Tips for Reducing Risk (cont)
Tips for Avoiding Unnecessary Pelvic Floor Injury:
Pregnancy
Talk with caregivers about avoiding routine use of
interventions that can increase risk
Carry out pelvic floor muscle exercises
Evidence Into Education, Advocacy:
Tips for Reducing Risk (cont)
Tips for Avoiding Unnecessary Pelvic Floor Injury:
1. Labor
Avoid routine use of interventions while pushing
2. After Birth
Continue pelvic floor muscle exercises
Evidence Into Education, Advocacy:
Tips for Reducing Risk (cont)
Tips for Avoiding Unnecessary Pelvic Floor Injury:
Throughout Life
Maintain healthy body weight
Avoid smoking
Continue pelvic floor muscle exercises
Minimize repeated urinary tract infections
Avoid hysterectomy, when possible
Avoid HRT, when possible
Evidence Into Education, Advocacy:
Cesarean Booklet
What Every Pregnant Woman Needs to Know
About Cesarean Section
Guided by recent literature on
• information needs of childbearing women
• risk communication, decision aids (e.g., BMJ 9/27/03)
• evidence-based risk reduction
Many partners provided
• extensive feedback on drafts to strengthen quality
• eventual endorsement
Evidence Into Education, Advocacy:
Cesarean Booklet (cont)
Main body:
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background
informed consent/informed refusal
review results in brief
main indications
tips for reducing risk
Appendix:
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details of outcomes that differ by mode of delivery
absolute risk difference
Evidence Into Education, Advocacy:
Resources for Pregnant Women
Printed booklet + summary insert (for purchase, bulk rates)
Booklet PDF file (no charge)
www.maternitywise.org/mw/topics/cesarean/cesareanbooklet
In-depth online Maternity Topics
• What should I know about cesarean section?
• Should I choose VBAC or repeat c-section?
• How can I prevent pelvic floor problems when giving birth?
www.maternitywise.org/mw/topics/
Evidence Into Education, Advocacy:
Media Outreach
Media briefing at New York Academy of Medicine
to release results of review and booklet
Press release and outreach
www.maternitywise.org/mw/topics/cesarean/cesareanbooklet
Matte release
Print PSAs for partners’ journals, newsletters
Evidence Into Education, Advocacy:
Professional Outreach
Presentations, often by clinical partners and with
booklet distribution to all registrants
Booklets/flyers at conference exhibits
Core review documents available online as PDFs
available at www.maternitywise.org/prof/cesarean/
Evidence Into Education, Advocacy:
Professional Outreach (cont)
PDF summary of review results
available at www.maternitywise.org/prof/cesarean/
Manuscripts in preparation
CME resources anticipated
Evidence Into Education, Advocacy:
Consultations, Adaptations
Policy and guidelines development
Adaptation for Kaiser Permanente/Northern
California
Adaptation for Canada (English, French),
Canadian Women’s Health Network
Spanish
Lower Literacy
Moving Forward: AHRQ Update
MCA participated in Evidence-based Women’s Health
Stakeholder meeting, encouraged fully resourced
federal review comparing cesarean/vaginal harms
MCA submitted invited overview of key issues
AHRQ subsequently decided to limit scope of question to
planned no-indication cesarean requested by women
Federal agencies have identified parameters for review;
Evidence-Based Practice Center is carrying it out
Moving Forward:
Randomized Controlled Trials?
Various Calls Throughout World:
RCT(s) to Assess Cesarean Without Medical Indication
“It will require a randomized, controlled, prospective study
to clearly define the benefits of elective prophylactic
cesarean delivery versus trial of labor. As the evidence
suggesting superior outcomes from elective prophylactic
cesarean delivery continues to mount, the time has come
for a controlled multicenter clinical trial to deny or confirm
the benefit of elective prophylactic cesarean delivery.”
ACOG Clinical Review 2005 editorial: Ralph W. Hale, W. Benson Harer, Jr.
Moving Forward:
Randomized Controlled Trials?
Not Ethical
Trials justified with “equipoise” and adequate informed
consent
Assertions of “equipoise” based on selective attention to
just a few outcomes
Skewed results strongly favoring vaginal birth render trials
unethical
Would women be willing to enroll with truly informed
consent?
Cannot (and will not) wait 20-25 years for results
Moving Forward:
RCT Not Information Panacea
Under-represent Harms of Cesarean
Follow-up expensive and challenging, especially far into
future
Need VERY large enrollment to measure rare, often lifethreatening outcomes (avoid “type II” errors)
Need MANY more to measure differences when women
randomized to vaginal birth “violate protocol” and have
cesareans
Even if funding, high enrollment, good follow-up occurred:
full results not available for 20-25 years, while 125 million+
babies born globally every year
Moving Forward:
RCT Not Information Panacea
Over-represent Harms of Vaginal Birth
Harms of vaginal birth management practices would be
assigned to “vaginal birth”
Urogynecologic measurement standards exaggerate harms:
• measuring during rather than after recovery period (more
likely with RCT)
• relying on surrogate markers
• relying on liberal definitions of incontinence without
regard to women’s experiences, quality of life
Moving Forward: RCTs on This
Topic will Profoundly Distort Results
Under-represent harms of cesarean (inability to measure
many serious outcomes or inability to detect differences)
Over-represent harms of vaginal birth (measurement
issues: co-interventions, definitions, timing, surrogate
measures)
Measure well only small proportion of harms that differ
Would erroneously confirm assertion of “equipoise” when
balance sheet in fact strongly favors vaginal birth
Beware of calls to settle matter through single RCT
Priority RCT:
How Can We Improve Vaginal Birth?
Need large well-funded and -executed trial comparing
• usual care vaginal birth
• physiologic vaginal birth
With appropriate sample sizes, definitions, follow-up
period, etc.
Outcomes of interest include: mode of delivery,
intrapartum interventions, and outcomes that
differed in MCA review and could be measured well
Moving Forward:
DES Tragedy Revisited?
Belief that DES offered benefits, had no serious downsides
has led to catastrophic outcomes many years later
Is this being repeated with casual and liberal use of
cesarean and effects of scarring, adhesions and
compromised placentation?
Presentation Bibliography
Full bibliography available at:
www.maternitywise.org/mw/topics/cesarean/booklet.html
See Methods and Sources PDF
Moving Forward
We welcome the opportunity to collaborate with others to
promote evidence-based maternity care.
Maureen P. Corry, MPH
Executive Director
[email protected]
212 777-5000, x 4
Carol Sakala, PhD, MSPH
Director of Programs
[email protected]
212 777-5000, x 5