A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)

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

749 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

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Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally.

The investigators envisage that the use of self administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot).

The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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misoprostol

3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

3 x 200mcg tablets of oral misoprostol

placebo

3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

3 x placebo tablets resembling misoprostol taken orally

Interventions

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Misoprostol

3 x 200mcg tablets of oral misoprostol

Intervention Type DRUG

placebo

3 x placebo tablets resembling misoprostol taken orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* pregnant women living in the recruitment villages of Mbale district at \>34 weeks gestation

Exclusion Criteria

* Any woman with a known allergy to misoprostol or other prostaglandins will be excluded as will any woman under 18 years old (unless she is an emancipated minor)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes