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

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
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
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, costeffective community-based interventions
 To disseminate results, increase political will
scale up, change local/national health policy
Global Network Sites
Nagpur,
India
Hyderabad,
Pakistan
Guatemala City,
Guatemala
US locations
New Orleans, Louisiana
Chapel Hill, North Carolina Buenos Aires,
Birmingham, Alabama
Argentina
Denver, Colorado
Montevideo,
Uruguay
Newark, Delaware
Philadelphia, Pennsylvania
Indianapolis, Indiana
Boston, Massachusetts
Research Triangle Park, North Carolina (DCC)
Eunice Kennedy Shriver NICHD
Eldoret,
Kenya
Kinshasa,
Democratic
Republic of
Congo
Belgaum,
India
Karachi,
Pakistan
Lusaka,
Zambia
http://gn.rti.org
Global Network Trials/Studies
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Preventing postpartum hemorrhage (MP)
Providing standard OB care
Preventing preeclampsia/eclampsia
Study of tobacco exposure & knowledge
Reducing perinatal mortality 2d 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
Prevention of Postpartum Hemorrhage
U.S. PI
SFI
Richard Derman, MD, MPH, University of MO, KC
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
September 2002
Enrollment began
December, 2005
Completed enrollment n=1613
Lancet 10/17/06
1 PPH prevented for every 18 women treated
Status
BRASSS-V®
Blood
Collection
Drape with
Calibrated
Receptacle
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 resourcepoor settings
Guidelines Trial
U.S. PI
SFI
Pierre Beukens, MD, PhD, UNC/Tulane
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
Changing Physician’s
Behavior: The Guidelines Trial
Changing Physician’s Behavior:
The Guidelines Trial
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
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
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
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
Availability & Registration of MP
Africa
• Nigeria
• Tanzania
• Zambia
• Uganda
• Ethiopia *
Asia
• India
• Bangladesh
• Nepal
* Training ongoing, awaiting approval
(Venture Strategies)
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
WHO collaborative trial
• What is the independent impact of
controlled cord traction
–Belgaum
–Argentina
• Use of BRASSS calibrated drape
Global Network for Women’s
and Children’s Health Research
http://gn.rti.org
Linda L. Wright, M.D.
[email protected]
301-402-0830 (O)
301-480-7773 (F)