Postpartum Hemorrhage
Conditions
Keywords
postpartum hemorrhage, PPH, misoprostol
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.
Interventions
DRUGMisoprostol
3 x 200mcg tablets of oral misoprostol
DRUGplacebo
3 x placebo tablets resembling misoprostol taken orally
Sponsors
University of Liverpool
Liverpool School of Tropical Medicine
Makerere University
Mbale Regional Referral Hospital
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Uganda
Outcome results
None listed