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New Research Calls for a Different Approach for Misoprostol for Postpartum Hemorrhage

By: Shafia Rashid, Senior Technical Advisor, Family Care International (FCI) Program of Management Sciences for Health

Postpartum hemorrhage (PPH)—excessive, uncontrolled bleeding during or after childbirth—is the leading cause of maternal death around the world.  Despite this, the condition is almost entirely preventable and treatable. In some parts of the world, women give birth at home or in health facilities lacking the essential supplies and equipment to manage PPH and other life-threatening complications.

Wherever a woman decides to give birth, she needs access to life-saving, uterus-contracting drugs, called uterotonics, for the prevention and treatment of PPH. The recommended uterotonic, injectable oxytocin, requires cold storage and technical skill to administer, making it difficult or impossible to use in many rural and low-resource areas. Misoprostol is a safe and effective uterotonic and a good alternative in community settings since it doesn’t require refrigeration or administration by a professional.

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The World Health Organization (WHO) and the global health community recommend that all pregnant women receive a uterotonic drug at the time of childbirth to prevent PPH regardless of their risk level, a model known as ‘universal prophylaxis.’ In many settings, however, achieving this model may not be feasible or cost-effective – especially in remote areas located far away from a health facility. Even with universal prophylaxis, some women (approximately 6-15%) will still develop PPH and require emergency care.

Partners from U.S. and Indian research institutions compared the universal prophylaxis model to one focusing on ‘early treatment,’ whereby only women who bleed more than 350 mL during labor are given a pre-emptive treatment dose of misoprostol. [1] Conducted in a rural district in southern India from 2011-2014, the study enrolled over 3,000 women who delivered with an Auxiliary Nurse Midwife (ANM) at home or in a health sub-centre, the most basic level of health facility.

In designing the study, the researchers emphasized the “imperative to create options to manage postpartum hemorrhage wherever women deliver, including the lowest levels of the health system.” The ANMs were randomly divided into two groups; those in the universal prophylaxis group gave 600 micrograms (3 tablets) of oral misoprostol to all women within five minutes of birth, and the early treatment group administered 800 mcg (4 tablets) of sublingual misoprostol to women who lost more than 350 mL of blood.

Results from the research shows that early treatment of PPH is a feasible alternative strategy to universal prophylaxis; there was no difference in the rates of bleeding and in the rates of transfer to a higher-level facility between the two approaches. Fewer women in the early treatment group than the universal prophylaxis group received medication (4.7% versus 99.7%), so early treatment has the potential to be more cost-effective. This model can also equip community level providers with a strategy to manage bleeding before it becomes life-threatening.

In discussing these findings, the researchers noted, “This new early treatment approach is an important step towards a more strategic placement of misoprostol for managing postpartum hemorrhage along the continuum of care.” Indeed, these findings also raise questions about the need for a universal prophylaxis approach, especially in remote and rural settings where women give birth at home.

[1] Research partners include Gynuity Health Projects; University of California, San Francisco; University of Illinois, Chicago; JN Medical College Belgaum, Karnataka; and BLDE University’s Shri B. M. Patil Medical College Bijapur, Karnataka

This post has been lightly edited from its original appearance on the FCI Blog.

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