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

Study Overview
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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.

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Misoprostol
* Drug: placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum hemorrhage, PPH, misoprostol