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

NCT01510574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 749

Last updated 2013-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

3 x 200mcg tablets of oral misoprostol

DRUG

placebo

3 x placebo tablets resembling misoprostol taken orally

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • Mbale Regional Referral Hospital

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Andrew Weeks · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01510574 on ClinicalTrials.gov