Postpartum Hemorrhage Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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