Trial Information

RCT of Misoprostol for Postpartum Hemorrhage in India

Despite existing knowledge of ways to effectively treat postpartum hemorrhage (PPH), lack of
resources in rural India has impeded improvement in rates of maternal mortality and
morbidity. Most births take place at home, and local auxiliary nurse midwives are not
trained or certified to administer injectable uterotonics. Reduction in postpartum
hemorrhage may decrease other adverse maternal outcomes such as the need for additional
uterotonic agents, blood transfusion, surgical intervention or death. The main hypothesis
of the study is that misoprostol administered orally during the third stage of labor will
significantly reduce the incidence of acute postpartum hemorrhage. The advantages of
misoprostol are: that it is relatively inexpensive, is an oral preparation of 600 mcg with a
long shelf life, and does not require refrigeration. One thousand six hundred women giving
birth in selected sites in Belgaum District, Karnataka, India will be randomly assigned to
misoprostol or placebo. The primary outcome is the incidence of acute postpartum
hemorrhage; secondary outcomes include incidence of delayed postpartum hemorrhage and
secondary infection; transport to higher-level facility; use of uterotonic agents; blood
transfusion; and maternal mortality for 42 days. A nested case-control analysis of women
who experience acute severe postpartum hemorrhage, compared to women who do not, will
identify socioeconomic, behavioral, cultural, and systems factors associated with postpartum
hemorrhage. For purposes of this study, acute PPH is defined as blood loss equal to or
greater than 500 ml within 2 hours of delivery and acute severe PPH as blood loss equal to
or greater than 1000 ml within 2 hours of delivery.

The sample size was based on a decrease of 50% PPH in the treated versus the control group;
20% rate of non-compliance, power of 96%, and a two-tailed type I error of 0.05