RCT of Misoprostol for Postpartum Hemorrhage in India

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Bill and Melinda Gates Foundation; Fogarty International Center of the National Institute of Health; Global Network for Women's and Children's Health Research; Jawaharlal Nehru Medical College; John E. Fogarty International Center (FIC); National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH); National Institute of Dental and Craniofacial Research (NIDCR); RTI International; University of Missouri-Columbia
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Gestational age equal to or greater than 28 weeks pregnant

• Planning to deliver at home or at a sub-center in the Belgaum District, Karnataka India

• Anticipating a spontaneous vaginal delivery

• Ability and willingness to provide informed consent

Exclusion Criteria:

• Previous caesarian section

• Scheduled for caesarian section

• Hemoglobin level less than 8 Gms%

• Episodes of antepartum bleeding during the current pregnancy

• Blood pressure more than 140 mm of Hg systolic and 90 mm of Hg diastolic

• In active labor and not previously screened, recruited, and consented

• Absence of fetal heart sounds

• Multiple pregnancy

• Known history of bronchial asthma

• Prior enrollment in this study during a previous pregnancy

• History of complications (ante/postpartum hemorrhage/retained placenta/ acute inversion of uterus) during a previous pregnancy

• High risk conditions including: diabetes, cardiac ailments, seizures, placenta previa or anticipated breech delivery.

• Receiving injectable medicine at time of delivery