An interventional study of Misoprostol in Postpartum Hemorrhage and Pregnancy, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 1 site in India. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-31.
Sponsored by NICHD Global Network for Women's and Children's Health · Not applicable, Interventional, and Prevention
Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, 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
446 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 146 across 341 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery
Incidence of delayed postpartum hemorrhage and secondary infection (lower abdominal pain, fever and foul discharge)
Transport to higher-level medical facility
Use of uterotonic agents
Blood transfusion
Surgical intervention including curettage, vacuum aspiration for retained placental tissue or hysterectomy
Maternal mortality for 42 days
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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NICHD Global Network for Women's and Children's Health