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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Misoprostol; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 749
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Mbale, Uganda
    • Mbale Regional Referral Hospital
  • Mbale, Uganda
    • Busiu Health Centre
  • Mbale, Uganda
    • Lwangoli Health Centre
  • Mbale, Uganda
    • Siira Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: misoprostol; 3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby	Drug: Misoprostol; 3 x 200mcg tablets of oral misoprostol
Placebo Comparator: placebo; 3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby	Drug: placebo; 3 x placebo tablets resembling misoprostol taken orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin	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	Measured during third trimester and 3-5 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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.	Assessed 3-5 days postpartum

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Makerere University; University of Liverpool; Liverpool School of Tropical Medicine; Mbale Regional Referral Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimate): January 16, 2012

Study Record Updates

• Last Update Posted (Estimate): March 13, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: postpartum hemorrhage, PPH, misoprostol
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 3002