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PPH Prevention:Â Where are we now and what is next?:

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  • 1. PPH Prevention: Where are we now and what is next? POPPHI Working Group Meeting Washington, DC April 6, 2009 Linda L. Wright, MD Deputy Director, CRMC Director, Global Network for Women’s & Children’s Health Research NICHD, NIH, DHHS
  • 2. NICHD and Gates Foundation Unique private-public sector collaboration to build maternal and child health capacity in the developing world through research partnerships Jointly established the Global Network for Women’s and Children’s Health Research in 2001 10 Research Units 1 Data Center (RTI) NIH scientific staff
  • 3.
    • Global Network Goals
    • To address common perinatal public health
    • problems to improve the outcome of women
    • and children in the developing world
    • To build scientific capacity and sustainable
    • research and public health infrastructures
    • To focus on feasible, sustainable, cost-
    • effective community-based interventions
    • To disseminate results, increase political will,
    • scale up, change local/national health policy
  • 4. Global Network Sites US locations New Orleans, Louisiana Chapel Hill, North Carolina Birmingham, Alabama Denver, Colorado Newark, Delaware Philadelphia, Pennsylvania Indianapolis, Indiana Boston, Massachusetts Research Triangle Park, North Carolina (DCC) Eunice Kennedy Shriver NICHD http:// gn.rti.org Montevideo, Uruguay Buenos Aires, Argentina Guatemala City, Guatemala Belgaum, India Karachi, Pakistan Hyderabad, Pakistan Lusaka, Zambia Kinshasa, Democratic Republic of Congo Eldoret, Kenya Nagpur, India
  • 5. Global Network Trials/Studies
    • Preventing postpartum hemorrhage (MP)
    • Providing standard OB care
    • Preventing preeclampsia/eclampsia
    • Study of tobacco exposure & knowledge
    • Reducing perinatal mortality 2 d asphyxia
    • Early home intervention for asphyxia
    • Emergency OB/neonatal care package
    • Optimizing infant nutrition and growth
    • Optimizing neonatal sepsis/pneumonia
    • care to reduce infant mortality
    • PK/PD study of artesunate in pregnancy
  • 6. Prevention of Postpartum Hemorrhage U.S. PI Richard Derman, MD, MPH, University of MO, KC SFI Bhalchandra Kodkany, MD, MBBS, Jawaharal Nehru Medical College Locations Village health posts of 4 primary health centers Design RCT placebo-controlled trial of 600 mcg misoprostol administered by ANMs to reduce postpartum hemorrhage; calibrated drape for blood loss Status September 2002 Enrollment began December, 2005 Completed enrollment n=1613 Lancet 10/17/06 1 PPH prevented for every 18 women treated
  • 7. BRASSS-V ® Blood Collection Drape with Calibrated Receptacle
  • 8. International PPH Congress: Goa, India July 2006
    • Recommendations
      • AMTSL be made available to all women
      • delivering anywhere in the world
      • Oral misoprostol 600 mcg is a safe and
      • effective alternative to injection oxytocin
      • 10 mg for preventing PPH in resource-
      • poor settings
  • 9. Guidelines Trial U.S. PI Pierre Beukens, MD, PhD, UNC/Tulane SFI Jose Belizan, MD Centro Lantinoamericano de Perinatologia (CLAP) Location 19 hospitals (Argentina-17, Uruguay-2) Design RCT of a behavioral intervention to increase the use of two evidence-based birth practices: selective use of episiotomies and use of oxytocin in the third stage of labor to prevent hemorrhage Status December 2003 Baseline #1 data collection (n=6597); 19 hospitals enrolled December 2005 Trial completed Sept 2007 1 yr followup completed n=5832 Published NEJM
  • 10. Changing Physician’s Behavior: The Guidelines Trial
  • 11. Changing Physician’s Behavior: The Guidelines Trial
  • 12. Global Network: Where are we now?
    • Indian MOH approved MP to prevent PPH
    • MP is registered by India’s Drug Controller
    • for prevention of PPH
    • Manufacture of generic MP has increased
    • in India from 1 to 4 companies
    • Cipla is developing a 600 mcg tablet
    • Belgaum has preliminary data suggesting
    • that 400 mcg powdered MP may be
    • effective
  • 13. Global Network: Where are we now?
    • Indian MOH, with WHO-SEARO, is:
      • promoting skilled birth attendance,
    • including MP
      • Karnataka State is the model for national
      • scale up
      • JNMC is the WHO Nodal Training Center
      • for Karnataka State
  • 14. Global Network: Where are we now?
    • Indian MOH, with WHO-SEARO
      • Train-the-trainer model used to train
            • - Academic faculty of 15
            • medical colleges
            • - District Hospital staff
            • - Medical Officers
      • Staff nurses and ANMs being trained in
      • the use of MP through Karnataka District
      • Training Centers
  • 15. Global Network: Where are we now?
    • GOI social marketing agency will distribute
    • a package to include oral MP, training for
    • IUD 380, MVA, etc. to all PHCs in Belgaum
    • District as part of promotion of skilled birth
    • attendance
    • Maharashtra State has supplied MP to PHCs
    • Global Network endorsed MP for prevention
    • of PPH for the WHO Essential Drug List
  • 16. Availability & Registration of MP
    • Africa
    • Nigeria
    • Tanzania
    • Zambia
    • Uganda
    • Ethiopia *
    • Asia
    • India
    • Bangladesh
    • Nepal
    • * Training ongoing, awaiting approval (Venture Strategies)
  • 17. Global Network: What is next?
    • Awaiting decision of WHO re endorsement
    • of MP for prevention of PPH for their EDL
    • Maximum effort to register MP widely in the
    • developing world
    • Additional dosing and preparation studies,
    • especially sublingual/active release
    • Additional generic MP manufacture to
    • reduce cost and increase availability
    • Emergency OB and Neonatal Care Trial
  • 18. WHO collaborative trial
    • What is the independent impact of controlled cord traction
      • Belgaum
      • Argentina
    • Use of BRASSS calibrated drape
  • 19. Global Network for Women’s and Children’s Health Research http://gn.rti.org Linda L. Wright, M.D. [email_address] 301-402-0830 (O) 301-480-7773 (F)