Transcript Adolescent Health

Global Health
Richard J. Derman, M.D. MPH
Chair, Department of Obstetrics and
Gynecology, Christiana Care
Director, Institute for Women and
Children’s Health Research
Professor, Obstetrics and Gynecology
Thomas Jefferson University
Why International Research?
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99% of maternal deaths occur in developing
countries
23% of pregnant women have no access to
antenatal care
39% of women deliver without a skilled birth
attendant
The death of a women is associated with
major negative outcomes for living children
The same conditions that kill women in the
developing world are leading causes of
mortality and morbidity in the U.S.
Maternal Health Task Force, 2009
Why Do Women Die?
530,000 maternal deaths annually
 Postpartum
hemorrhage
 Eclampsia
 Infection/Septic
Abortion
PPH’s Contribution to Mortality and Morbidity
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The single most important cause of maternal
death worldwide.
At least 1/4 of all worldwide maternal deaths
(> 530,000) are due to PPH.
14,000,000 cases of pregnancy-related
hemorrhage each year with at least 128,000
of these women bleeding to death.
The percentage of all pregnancy-related
deaths due to hemorrhage is 19% in the
United States.
Global Scenario
WHO - UNICEF - UNFPA
Maternal
Deaths
(Number)
India
136,00 540
0
Develope 2,500
d regions
World
Total
Maternal Mortality
Ratio
(deaths per 100,000
live births)
20
529,000 400
Life time risk
of maternal
death
1 in:
48
2,800
74
PPH Non-Predictable
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Two-thirds of women who hemorrhage
have no identifiable risk factors
Similar ratio among PP hemorrhage
deaths in US
Women who survive often must receive
blood transfusion - ↑ risk of hepatitis or
HIV
Average Interval from
Onset to Death
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Ruptured uterus
24 hrs
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Antepartum hemorrhage
12 hrs
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Postpartum hemorrhage
2 hrs
Maine D. Safe Motherhood Programs: Options and Issues, Center for Population & Family
Health,
Columbia University,1993.
Strategies for Reducing
Postpartum Hemorrhage
Secondary to Atonic Uterus
Active Management of the
Third Stage of Labor
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Designed to speed the delivery of the
placenta by increasing uterine contractions
and thus averting uterine atony (60%
reduction in risk)
Components
– Administration of uterotonic agent (post
cord-clamping)
– Placenta delivered by controlled cord traction
with counter-traction on the fundus
– Uterine massage > delivery of placenta
FIGO Joint Statement June, 2004
Active Management of the Third Stage of
Labor without Controlled Cord Traction:
A Randomized Non-inferiority Controlled Trial
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Uterotonic use likely has greatest impact
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Concern over controlled cord traction in rural
areas among nonphysicians
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If not significant change in bleeding, can
recommend against the practice and expand
AMTSL to lower level providers
Gulmezoglu, M, et al., Reproductive Health, 2009 Jan, 6:2. (World Health Organization)
A Randomized Placebo-Controlled Trial of
Oral Misoprostol for
Prevention of Postpartum Hemorrhage
at Four Primary Health Centers of the
Belgaum District, Karnataka India
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Richard J. Derman, MD,
MPH
Bhala Kodkany, MD
V.J. Naik, MD
Ashlesha Patel, MD,
MPH
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Shiva Goudar, MD
Stacie Geller, PhD
Stanley Edlavitch,
PhD
Study Sponsors
Intervention
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Misoprostol or Placebo
#3, 200 mcg tablets, orally
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Administered within 5 minutes of
clamping and cutting of the cord and
cessation of cord pulsation
Primary
Outcome
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Objective
Measurement of
Blood Loss
BRASSS-V®
Blood Collection
Drape with
Calibrated
Receptacle
BRASSS-V Blood Collection Drape
with Calibrated Receptacle
Primary Hypothesis
Misoprostol administered during the
third
stage of labor will significantly reduce
the
incidence of acute postpartum
hemorrhage by 50%.
Oral misoprostol in preventing postpartum
hemorrhage in resource-poor communities:
a randomized controlled trial
Lancet 2006; 368: 1248-53
PPH Rates
Primary Outcome
Postpartum
Hemorrhage
(blood loss  500
ml)
Severe
Postpartum
Hemorrhage
(blood loss 
1,000 ml)
Misoprostol
(n= 812*)
n (%)
53 (6.5)
2 (0.2)
Placebo
(n=805)
n (%)
97
(12.0)
10 (1.2)
ss
Pvalu
e
0.000
1
One case of postpartum hemorrhage
was prevented for every 18 women
who received Misoprostol
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Price now reduced to 12 cents/dose
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Registered in 14 countries in Africa
and Asia
Postpartum Hemorrhage Rates for Data Review
Periods of Randomized Women by Treatment
20
17.7
18
Misoprostol
Placebo
16
14
12.3
12.0
% PPH
12
9.5
10
9.2
8.3
8
6.7
6.5
6.4
6
4
n=219
n=254
n=119
2
n=256
n=121
n=220
1.9
n=808
n=216
n=811
n=215
0
1
2
3
4
Overall
Data Review Periods
Goudar SS, et al., Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol. J
Matern Fetal Neonatal Med. 2008 Aug; 21(8):559-64
What Measured Blood Loss Tells Us
About Postpartum Bleeding:
A systematic review
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Prevalence of PPH (>500 ml) 10.55%
in 19 studies where blood loss was
measured vs. 7.23% with visual
estimation
Ongoing debate about changing the
definition of PPH – (clinical instability,
drop in Hgb of >10% or >750ml)
Sloan N, et. al. BJOG, 4/2010
Management of PPH
Low Resource Settings
Is it more cost effective to prevent or to treat?
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Aggressive Treatment of PPH
– Misoprostol 800-1000 mcg
rectally/sublinguinal
– UNIJECT® - Oxytocin
 Prefilled,
 Single
nonrefillable, sterile
dose
 Auto-disable
syringe
Inflated condom in a kidney tray
Non-inflatable Anti-shock Garment
Reducing Morbidity and
Mortality of PPH
(Lessons learned from the U.S.)
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Team training
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Use of simulation laboratories
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Rapid response team drills
– massive transfusion protocol
Hospitals in lowest quartile of deliveries have
mortality/hysterectomy rates  71%
Bateman B. et al. Anaes-Analg, 2010.
Newborn Care Training and Perinatal
Mortality in Developing Countries
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3.7 million neonatal deaths
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3.3 million stillbirths (majority fresh
stillbirths)
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98% occur in developing countries
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An evaluation of community-based
interventions is needed
Carlo W, et al. NEJM Feb 18, 2010
First Breath Trial
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Six country study instituted (DRC, Zambia, India,
Pakistan, Guatemala, Argentina)
Train the trainer model
Employed WHO ENC training model
– Routine neonatal care
– Resuscitation
– Thermoregulation
– Breast feeding
– Skin-to-skin care
Carlo W, et al. NEJM Feb 18, 2010
Selected GN Research Advances
 “FIRST
BREATH”: 30% reduction
in the rate of stillbirths following
basic training in resuscitation and
newborn care for birth attendants.
 120,000 births and 3,600 birth
attendants trained
NEJM, 2010; 362:614-623
Reducing Perinatal Mortality in
Community Settings
 Site-specific
findings in Belgaum are
consistent with a 30%  in neonatal
mortality in Nepal and a similar reduced
risk by training TBAs’ in Pakistan.
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Reduction in mortality beyond a certain
level likely requires access to facility care
with emergency preparedness.
Goudar, et al., In Press
EMONC
The GN is currently conducting a trial
employing a package of interventions
including:
 Home-based lifesaving skills
 Training of all birth attendants
 Facilitation of transport
 Community mobilization
 Death audit
Global Network Registry
Collection of registry data on
maternal
and neonatal deaths, allowing for
population-based research,
identification of
effective interventions and
development of
evidence-based health care policies.
N=160,000
Next Multi-site Study in Concert with WHO
Trial of antenatal steroids to reduce
mortality among preterm/low birth
weight infants in limited-resource
settings.
Exposure of Pregnant Women to Indoor
Air Pollution (10 sites, 9 countries)
 Largest
survey among pregnant
women in developing world
 Concerns over cooking with animal
dung, crop residue and charcoal
 Safety issue relating to open fires
indoors
 Impact of second hand smoking
Data suggests poorer pregnancy outcomes
Kadir, MM et al. Acta OB et GYN 2009
Global Alliance on Clean Cook Stoves
“NICHD joins the Dept of State, the EPA, the
CDC, and other federal partners in
supporting this initiatives of the UN
Foundation to address the health,
environmental, economic, and gender risks
associated with the use of solid fuels in
traditional cook stoves by about half of
world’s population”
Guttmacher, A
Conclusion
 We
know how to reduce maternal
and neonatal mortality
 Keys
to success must incorporate:
Education of all birth providers
Team training
Community involvement
Implementation and dissemination
research