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9/07/2015 The Western Australian Preterm Birth Prevention Initiative John Newnham School of Women’s and Infants’ Health The University of Western Australia, Perth, Western Australia Estimated Preterm Birth Rates 2010 The Western Australian Preterm Birth Prevention Initiative The problem For the mother Increased risks of obstetric intervention and separation from child For the newborn Increased risks of death, cerebral haemorrhage, respiratory support, bowel necrosis and sepsis For children Increased risks of cerebral palsy, chronic lung disease, deafness, blindness, learning difficulties and behavioural problems. Preterm birth is the single greatest cause of death and disability in children under 5 years in developed countries Is #2 in developing countries For adults Increased risks of metabolic syndrome, diabetes/heart disease, loss of employment and socialisation issues. Blencowe et al, Lancet 2012 THE WESTERN AUSTRALIA PRETERM BIRTH PREVENTION INITIATIVE Protocol Development Fundraising (WIRF) Preterm Birth Prevention Clinic State-Wide Outreach Program Public Health Program Operation In Western Australia: • 8-9% of all births in WA are preterm • 14-15% in Aboriginal Australians • Approximately 2800 preterm births from 33,000 births each year Development Aim: To safely lower the rate of preterm birth in Western Australia Steering Committee Stakeholders Executive Committee Governance The Western Australian Preterm Birth Prevention Initiative Ongoing research; Monitoring and analysis Community engagement 1 9/07/2015 Outreach for the general public • • • • • Mailed to 2718 medical practitioners in WA November 2014 16-page magazine State-wide distribution 160,000 copies sent Readership 624,000 Feb 25th, 2015 The Western Australian Preterm Birth Prevention Initiative Providing Medical practitioners and midwives with education on the clinical guidelines and scientific basis underpinning The Western Australian Preterm Birth Prevention Initiative (The Whole Nine MonthsTM). The financial cost: • In USA in 2007, the cost of immediate PTB was $US 26 billion. • In Perth North Metro Region neonatal cost is $116 million each year • In KEMH the direct cost of neonatal care is $54 million each year. Business Case: The Clinic component of the Initiative is cost-effective if in one year it: • Prevents the birth of just two newborns <750g Or • Delay the birth of three newborns from <750g to 1500–1999g weight range Progesterone treatment for women based on a history of preterm birth The Western Australian Preterm Birth Prevention Initiative The Six Strategies Rate of reduction NHMRC Level of Evidence IM 1 Progesterone supplementation 45% Level I 2 Cervical cerclage 20% Level III-1 3 Prevent non-medically indicated late preterm birth 55% Level III-3 4 Tobacco control • Prevent smoking in pregnancy • Smoke-free legislation 20% 10% Level III-2 Level III-3 5 Judicious use of fertility treatments 63% Level I 6 Dedicated PTB Prevention Clinic 13% Level III-2 Vaginal Total Progesterone reduces the risk of recurrent birth <37 weeks by half Cochrane, 2013 2 9/07/2015 Progesterone treatment based on history The short cervix on trans-vaginal scan Clinical guideline: In women with a past history of preterm birth or a previous pregnancy loss between 20 and 34 weeks gestation. The treatment should commence at 16 weeks and continue until 36 weeks gestation. In this circumstance, the progesterone treatment will halve the risk of recurrence of a preterm birth. Progesterone treatment based on length of cervix Short with open cervix Normal The Hassan/Romero RCT of vaginal progesterone • • • • • Vaginal progesterone halves the risk of PTB in women with a short cervix 190 to 236 weeks gestation Cervix 10-20 mm (2.3%) Primary end-point: birth <33 weeks Multi-centred USA 32,000 women screened Hassan S et al Ultrasound Ob Gyn 2011:38:18 The Hassan/Romero RCT of vaginal progesterone • Outcomes • Vag Prog (n) • Placebo (n) • P value • Birth < 28 weeks • 12/235 • 23/223 • 0.036 • Birth < 33 weeks • 21/235 • 36/223 • 0.020 • Birth < 35 weeks • 34/235 • 52/223 • 0.016 • Birth < 37 weeks • 71/235 • 76/223 • 0.376 • Effect only at earlier gestational ages • Screened 32,000 to prevent 15 births < 33 weeks (treatment arm) Screening the cervix in Western Australia • Measurement of cervix length is now recommended at all 18-20 weeks anatomy scans • Trans-abdominal scan is satisfactory if the pregnancy is low risk and length >35 mm. • All other measurements to be trans-vaginal. In WA in 2013, we had 482 births <33 weeks (1.4%) • State-wide standardised guidelines and education package Therefore, in one year in WA, if we screened 32,000 pregnancies at their routine 18-20 week scan, we would identify 733 suitable women (2.3%) and prevent 47 births < 33 weeks (15x2 add 1/3rd) • Effects of implementation will be monitored Hassan S et al Ultrasound Ob Gyn 2011:38:18 3 9/07/2015 1. Progesterone treatment Progesterone treatment based on cervix length Vaginal progesterone pessaries Clinical guideline: 100 or 200mg In pregnant women found on ultrasound imaging between 16 and 24 weeks gestation to have a shortened cervix with a length between 10 and 20mm. Cost to public hospitals $120/month ($4 each) The incidence of shortened cervix at this gestational age in the general population is 2-3%. Costs to patients: • Public patients $29.50 per month ($1 each) • Concession card holders $6 per month (20 cents each) When prescribed in this circumstance, the treatment will halve the risk of early preterm birth. If the cervix length is <10mm, the options include progesterone or cerclage. Costs in private variable PBS only for Assisted Reproduction Progesterone treatment to prevent preterm birth 2. Prevention of non-medically indicated late preterm birth Late preterm birth - 340/7 to 366/7 Day 1 239 259 280 366/7 40 • Only applies to pregnancies with a single fetus • Evidence at this time suggests is ineffective in multiple pregnancies Week LMP 340/7 72% of all preterm births are “late preterm” The Western Australian Pregnancy Cohort 1989-2014 Late preterm births Increased rates of: • Death • Respiratory problems – RDS, “wet lung”, apnea • Hypothermia • Hypoglycemia • Jaundice • Feeding difficulties • Sepsis • Neonatal care • Separation from mother • Re-admission Infants born between 37 0 and 376 weeks had increased behavioural problems: • • • • Overall (OR 1.43, 95% CI 1.02, 2.01) Externalising (OR 1.42, 95% CI 1.01, 2.01) N = 238 out of 2900 No effect at 38 weeks In childhood: • Learning difficulties • Behavioural problems 4 9/07/2015 Percentage of all liveborn births <32 and 32-36 weeks gestation in Western Australia Singleton preterm birth rates - USA Intervention Fig 2 Shapira-Mendoza 2012 Preterm births 32-36 weeks have increased by 50% in 27 years • 1990-2006 rate of singleton late PTB rose 21% • Late PTB accounted for almost all the increase • Effective reduction since then Shapiro-Mendoza 2012 Three strategies to reduce non-medically indicated birth <39 weeks gestation in USA Three strategies to prevent non-medically indicated birth <39 weeks USA 2007 • 27 hospitals in 14 states in 2007; • 3 month period including >17,000 births Hard stop After education, medical staff in each facility could choose: Soft stop 1. “Hard Stop” All pure elective births < 39 weeks prohibited 2. “Soft Stop” Education No prohibition, but all elective births <39 weeks reviewed for potential action 3. “Education only” Effectiveness: Hard stop > Soft stop > Education Clark et al, AJOG 2010; 203: 449.e1-6. Non-medically-indicated late preterm births Balancing preterm birth versus risk of stillbirth Our strategy: • • • • • Prevention of non-medically indicated late preterm birth Clinical guideline: All pregnancies should continue until at least 38 weeks gestation, unless there is a medical or obstetric reason justifying earlier intervention Cut-off 38+ weeks Education of workforce Awareness raising in our childbearing women Use of tests of fetal wellbeing if required Audit 5 9/07/2015 6. The Preterm Birth Prevention Clinic 4. Smoking in pregnancy In Western Australia 2010 – 2012: • 14% of pregnant women smoked • 49% of Aboriginal pregnant women smoke and the rate is unchanged • Smoke-free legislation is the most effective strategy • We will harness the excellent public policies from our Health Department • But our public health messages have not been aimed at preterm birth prevention • For referral of women at high risk based on history. • Expect 1-3 visits and then referral back to health care provider • Most women will only need a treatment plan • Teleconferencing whenever possible • Linked to the KEMH MFM (Gold) Team • Commenced November 2014 • Is a pilot to be evaluated in mid-2015 The Western Australian Preterm Birth Prevention Initiative The Western Australian Preterm Birth Prevention Initiative Research: • PTB Prevention is a major research area for us • Funded by NIH and NHMRC >24 years • New NHMRC vaginal microbiology project grant 2015-17. • Targeting intra-uterine infection in 2nd trimester • Genetic predictions show promise WA PTB Prevention Initiative - Steering Committee Data monitoring and analysis: • Western Australia is the ideal “island” • Outcomes to be monitored by Midwifery Notifications and data linkage • Cost-effectiveness evaluated Let’s keep in touch Name Organisation John Newnham Chair Graeme Boardley A/Executive Director, WNHS John Challis Pro-VC Health & Medical Research UWA Jan Dickinson Head, MFM, KEMH Women and Infants Research Foundation Dorota Doherty Head of Biostatistics, WIRF The Whole Nine Months Michael Gannon President, WA Branch, AMA Janet Hornbuckle Head, Obstetrics, KEMH @WIRFWA Anne Karczub Director, Obstetrics, KEMH/SOSU Jeffrey Keelan Head of Research, WNHS Barbara Lourey Clinical Midwifery Manager, KEMH Suzanne Meharry Obstetrician, PTB Prevention Clinic Diane Mohen Co-Director, SOSU Craig Pennell Head of PTB Prevention Clinic Bronwyn Rose CE, Tiny Sparks WA Tarun Weeramanthri Head, Public Health, WA Health Dept Vicki Westoby GP Liaison Officer, KEMH Tina Williams Operations Manager, WIRF Get out your phone and like / follow #thewholeninemonths #healthywomenhealthybabi es 6