|Drug Prevents PostPartum Hemorrhage in Resource
Advance Has Potential to Save Thousands of Lives
The drug misoprostol provides a safe, convenient, and inexpensive
means to prevent postpartum hemorrhage, a major killer of women
in developing countries. The study was conducted by researchers
from the University of Missouri, India’s Jawaharlal Nehru Medical
College, the National Institutes of Health, and other institutions.
Postpartum hemorrhage is excessive bleeding experienced by the
mother after giving birth. The condition can result from failure
of the uterus to contract after detachment of the placenta or from
ruptures or tears in the uterus and other tissues.
The study, conducted with women in rural India, appeared in the
October 7 Lancet, and was funded by the Global Network
for Women's and Children's Health Research, a public-private partnership
between NIH’s National Institute of Child Health and Human Development
and the Bill and Melinda Gates Foundation. The NICHD Global Network
for Women's and Children's Health Research supports research based
on sound scientific evidence. The Network supports research seeking
to improve medical treatments, procedures and preventive measures
that will reduce death and disability in women, infants, and children
in resource poor-countries. Only interventions which are cost-effective
and appropriate for use in developing countries are evaluated by
the network. The Global Network pairs U.S. and foreign investigators
to increase scientific capacity, research infrastructure, and sustainability.
The study was conducted by researchers in the United States and
India. The American team, led by Richard J. Derman, M.D., M.P.H,
of the University of Missouri-Kansas City School of Medicine, also
included Nancy Moss, Ph.D. from NICHD. The Indian authors of the
study included Bhalchandra S. Kodkany, M.D, and colleagues from
the Jawaharlal Nehru Medical College, Belgaum, Karnataka. Researchers
from the University of Illinois Chicago College of Medicine, the
John H Stroger Jr. Hospital of Cook County and RTI International
also took part.
“The researchers showed that giving women misoprostol after birth
is a safe, inexpensive means to prevent postpartum hemorrhage from
occurring,” said NIH Director Dr. Elias A. Zerhouni. “This advance
has the potential to save thousands of lives each year.”
In developed countries, where the majority of births occur in
hospitals and emergency care is available, deaths from postpartum
hemorrhage are rare. However, the condition can be life-threatening
in countries where most births occur at home and emergency care
is not always available.
The study authors noted that in rural India, 50 percent of births
occur at home or in facilities without a physician in attendance.
The estimated maternal death rate in that country is 407 women
for every 100,000 births. The study authors also cited estimates
that, worldwide, about 500,000 maternal deaths occur during childbirth
each year, with postpartum hemorrhage accounting for about 30 percent
of those deaths. The comparable rate in the U.S. is about 10 maternal
deaths per 100,000 births, with postpartum hemorrhage accounting
for about 17 percent of these deaths.
In developed countries, oxytocin is the standard drug used to
prevent postpartum hemorrhage, explained Nancy Moss, the NICHD
author and project officer for the study. The drug stops bleeding
in the uterus by causing the uterus to contract. But oxytocin should
be kept cold, and must be given by trained medical personnel — conditions
that make it unsuitable for use in parts of the world where most
births are at home and refrigeration and skilled medical personnel
are in short supply.
But the drug misoprostol, which also stops uterine bleeding by
causing the uterus to contract, does not require refrigeration.
It can be given once after delivery as 3 oral tablets costing as
little as $.14 each. Its use does not require highly trained personnel
and it can be given by semi-skilled birth attendants.
The researchers conducted the current study to determine if misoprostol
could provide an effective way to prevent postpartum hemorrhage
in countries where hospital services are in limited supply. Between
September, 2002 and December 2005, Dr. Kodkany and colleagues from
Jawaharlal Nehru Medical College recruited 25 nurse midwives who
serve the rural villages of the Belgaum District in Karnataka State.
The nurse midwives were instructed how to administer the 3 tablets
of misoprostol and how to measure blood loss following the birth.
To provide an accurate measure of blood loss, the researchers developed
a calibrated plastic blood collection drape that measures blood
loss. The drape was placed underneath the reclining woman after
she had given birth.
Women who volunteered to participate were randomized early in
labor to receive either 600 micrograms of misoprostol or an identical
looking placebo immediately after they gave birth. Only women who
did not have any serious health problems were enrolled into the
study. Of the 1620 women who took part, 812 received misoprostol,
and 808 received a placebo. Neither the nurse midwives nor the
women knew who received misoprostol and who received the placebo.
The study authors found that women who received misoprostol were
less likely to experience acute postpartum hemorrhage, which was
defined as the loss of from 500 milliliters to just under 1000
milliliters of blood (slightly more than a pint to slightly more
than a quart.) “Only 6.4 percent of the women receiving misoprostol
experienced acute postpartum hemorrhage, compared with 12 percent
in the placebo group,” Dr. Moss said.
Dr. Moss added that misoprostol also significantly reduced the
average blood loss of women who received the drug.
The women in the misoprostol group also had fewer occurrences
of acute severe postpartum hemorrhage — the loss of 1000
milliliters or more of blood. Overall, the researchers reported
that one case of postpartum hemorrhage was prevented for every
18 women treated.
Side effects of the misoprostol treatment consisted of a modest
increase in shivering and fever, both common side effects of the
drug. Infants of nursing mothers who took misoprostol showed no
“We now have proven that misoprostol is a convenient, inexpensive,
safe, and effective drug to lessen a major cause of death of women
in the developing world — postpartum hemorrhage,” Dr. Moss
The NICHD sponsors research on development, before and after
birth; maternal, child, and family health; reproductive biology
and population issues; and medical rehabilitation. For more information,
visit the Institute’s Web site at http://www.nichd.nih.gov/.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.