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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
- Change in hemoglobin [ Time Frame: Measured during third trimester and 3-5 days postpartum ] [ Designated as safety issue: No ]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
- Safety [ Time Frame: Assessed 3-5 days postpartum ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||May 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: misoprostol
3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby
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
3 x placebo tablets resembling misoprostol taken orally
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510574
|Mbale Regional Referral Hospital|
|Lwangoli Health Centre|
|Busiu Health Centre|
|Siira Health Centre|
|Principal Investigator:||Andrew Weeks||University of Liverpool|