Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

Gynuity Health Projects

Status: Completed

Conditions: Anemia; Postpartum Hemorrhage

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00120237

2.4.4

Details and patient eligibility

About

This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.

Enrollment: 1,600 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women in general good health, home delivery
• Must live in one of 78 study villages

Exclusion criteria

• Hypertension
• Non-cephalic presentation
• Polyhydramnios
• Previous cesarean section
• Suspected multiple pregnancy
• Suspected still birth
• Antepartum hemorrhage
• Previous complication in 3rd trimester
• Anemia of <8 g/dl

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind