RCT of Misoprostol for Postpartum Hemorrhage in India

NICHD Global Network for Women's and Children's Health

Status

Completed

Conditions

Postpartum Hemorrhage

Pregnancy

Treatments

Drug: Misoprostol

Study type

Interventional

Funder types

Other

NETWORK

NIH

Identifiers

NCT00097123

GN 08

U01HD042372 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment

1,600 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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