Clinical trial NCT02853552: Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding
Official title: Use of Misoprostol by Families and Women as a First Aid Measure to Address Excessive Postpartum Bleeding in Home Deliveries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: National Committee for Maternal & Neonatal Health
First posted: 2016-08-03
Enrollment: 4330
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births.

Detailed description: This is a quasi-experimental, pre-post intervention study that will be conducted over a period of 12 months and will span two phases:

Phase 1 (baseline) (6 months): Data on deliveries will be collected for pregnant women who deliver during this phase. Data will also be collected on the treatment administered in any PPH cases. Women will be counseled on and also receive educational materials on how to identify excessive bleeding and the importance of seeking care at a facility if excessive bleeding occurs.

Phase 2 (misoprostol) (6 months): During this phase, the study will pilot the first aid concept. Women will be provided with a single dose of 800 mcg sublingual misoprostol (200 mcg x 4 tablets) during their third trimester to use in the event of excessive postpartum bleeding, as well as the educational materials and counseling provided during the Phase 1. The misoprostol is intended to serve as a first aid treatment measure and although seeking additional care is challenging in this setting, women and families will be advised to have a plan ready to seek immediate care at a health facility as soon as they take the misoprostol.

During both study phases, data will be collected on maternal, clinical, and neonatal outcomes for all deliveries that occur in the study area. If women receive any care related to their delivery, data collectors will document this information.

Eligibility criteria: Inclusion Criteria:

* Pregnant women living in sample districts

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Number of cases identified as having excessive bleeding
timeFrame: Within 1 week after delivery
measure: Proportion of women who administer misoprostol as first aid
timeFrame: Within 1 week after delivery
measure: Proportion of women who correctly administer misoprostol as first aid
timeFrame: Within 1 week after delivery
measure: Acceptability of side effects of misoprostol
timeFrame: Within 1 week after delivery
measure: Number of women who are transferred for excessive bleeding
timeFrame: Within 1 week after delivery
measure: Proportion of women who experience a serious adverse event due to excessive bleeding
timeFrame: Within 1 week after delivery
measure: Proportion of women who receive an additional intervention (e.g. use of additional uterotonic or suturing) for excessive bleeding
timeFrame: Within 1 week after delivery
measure: Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding
timeFrame: Within 1 week after delivery
measure: Correct comprehension of information related to misoprostol and its use for first aid
timeFrame: Within 1 week after delivery
Secondary outcomes:
Other outcomes:
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Study officials:
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