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

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Misoprostol; Drug: placebo

• Registration Number: NCT01510574
• Lead Sponsor: Gynuity Health Projects

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-16
• Study Start: 2012-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 749

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol	Misoprostol	3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby
placebo	placebo	3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin	Measured during third trimester and 3-5 days postpartum	Peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot) following use of self-administered misoprostol after home birth

Secondary Outcome Measures

Name	Time	Method
Safety	Assessed 3-5 days postpartum	To assess the safety of ante-natal distribution of misoprostol and its use by women at the time of their home birth, data will be collected on the number of women who report experiencing side effects (including shivering and fever), number of women who are transferred to higher level care, number of women who undergo surgical interventions, number of women who are given blood transfusions, number of maternal deaths, and number of neonatal deaths.; The exact outcomes as well as the power calculations will only be finalized once the pilot study is completed.

Trial Locations

Locations (4)

Busiu Health Centre; 🇺🇬 Mbale, Uganda

Lwangoli Health Centre; 🇺🇬 Mbale, Uganda

Siira Health Centre; 🇺🇬 Mbale, Uganda

Mbale Regional Referral Hospital; 🇺🇬 Mbale, Uganda