Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Misoprostol by Families and Women as a First Aid Measure to Address Excessive Postpartum Bleeding in Home Deliveries

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women living in sample districts Exclusion Criteria: Unable to provide informed consent
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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Misoprostol|800mcg misoprostol taken sublingually|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases identified as having excessive bleeding |  | Within 1 week after delivery | 
| Proportion of women who administer misoprostol as first aid | Proportion of women who took misoprostol to treat excessive bleeding out of women who self-diagnosed excessive bleeding | Within 1 week after delivery | 
| Proportion of women who correctly administer misoprostol as first aid | Proportion of women who administer misoprostol by correct route and correct dose for treatment of excessive bleeding out of all women who administer misoprostol for treatment of excessive bleeding | Within 1 week after delivery | 
| Acceptability of side effects of misoprostol |  | Within 1 week after delivery | 
| Number of women who are transferred for excessive bleeding | Women who are receive care for heavy bleeding by a skilled provider at home or at a health facility | Within 1 week after delivery | 
| Proportion of women who experience a serious adverse event due to excessive bleeding | Proportion of women who experience a SAE (defined as laparotomy, surgery, hysterectomy, blood transfusion or death) out of all women who experience excessive bleeding | Within 1 week after delivery | 
| Proportion of women who receive an additional intervention (e.g. use of additional uterotonic or suturing) for excessive bleeding |  | Within 1 week after delivery | 
| Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding |  | Within 1 week after delivery | 
| Correct comprehension of information related to misoprostol and its use for first aid | Proportion of women who correctly answer questions related to use and administration of misoprostol for first aid to treat excessive bleeding | Within 1 week after delivery |