Drug prevents postpartum hemorrhage in resource poor settings

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, and the National Institutes of Health.

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.

"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 side effects.

"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 said.

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Note: An embargoed briefing for the news media will be held today, October 4, 2006, in advance of study release appearing in the October 7 Lancet, by researchers from the NIH and other institutions in the United States and India.

Teleconference name: NICHD Research on Postpartum Hemorrhage

U.S. Media Dial (800) 553-5260
International Media Dial (612) 332-0636

Important Instructions: If you would like to ask a question during the call press *1 on your touchtone phone; to withdraw your question press *2. You may queue up at anytime. You will hear a tone to indicate your question is pending. A rebroadcast will be available for 24 hours after the briefing. To listen to the rebroadcast, dial (800) 475-6701 (USA) or (320) 365-3844 (International), Access code: 843638.

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 http://www.nih.gov


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