Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Study Overview
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Brief Summary
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This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

Detailed Description
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This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Official Title
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Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in UnijectTM in Mali

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: misprostol
* Device: UnijectTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women delivering at home with a trained study provider who are able to provide informed consent Exclusion Criteria: women with known contraindications to prostaglandins
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>600 mcg oral misoprostol administered during the third stage of labor | Drug: misprostol<br>* 600 mcg misoprostol oral<br>* Other names: Cytotec;|
| Experimental: UnijectTM<br>10 IU oxytocin delivered IM with UnijectTM during he third stage of labor | Device: UnijectTM<br>* 10 IU oxytocin delivered intramuscularly with UnijectTM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in hemoglobin | To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible. | during 3rd trimester and 1-3 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence and management of side effects | nausea, vomiting, diarrhea, shivering, fever | 1 hour postpartum | 
| correct timing of drug administration | administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta | collected immediately following birth, verified 1-3 days postpartum | 
| change in hemoglobin ≥ 2 g/dL |  | during third trimester and 1-3 days postpartum | 
| additional interventions | use of additional uterotonics, manual removal of placental fragments, etc | during birth and 1-3 days postpartum | 
| referrals | referral requested, transfers carried out, reasons for incomplete referrals/transfers | 1-3 days postpartum | 
| acceptability | acceptability according to woman of study medication, care received, side effects experienced | 1-3 days postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum hemorrhage, prevention, misoprostol, Uniject, oxytocin