Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Misoprostol

600 mcg oral misoprostol administered during third stage of labor

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes