Misoprostol for the Treatment of Postpartum Hemorrhage

Study Overview
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Brief Summary
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The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.

Detailed Description
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Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not. Blood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions: Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor? Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH? Is the side effect profile of misoprostol acceptable to women? This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.

Official Title
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Misoprostol for the Treatment of Primary Postpartum Hemorrhage

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaginal delivery Postpartum hemorrhage due to suspected uterine atony Depending on study group: administration of prophylactic uterotonics in third stage of labor Exclusion Criteria: Known allergy to misoprostol or other prostaglandin C-section for current delivery
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>800 mcg sublingual misoprostol | Drug: Misoprostol<br>* 800 mcg sublingual misoprostol<br>|
| Active Comparator: Oxytocin<br>40 IU Oxytocin IV | Drug: Oxytocin<br>* 40 IU Oxytocin IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for additional treatment after initial PPH study treatment |  | all additional interventions recorded following initial uterotonic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood loss after PPH treatment |  | blood loss measured for minimum of 1 hour or until active bleeding ceases | 
| Change in hemoglobin from pre-delivery to postpartum |  | Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV | 
| Time to bleeding cessation |  | Time to bleeding cessation recorded | 
| Blood transfusion |  | any blood transfusion recorded after delivery and prior to discharge | 
| Side effects |  | any observed or reported side effects recorded following treatment and prior to discharge | 
| Acceptability for women |  | Exit interview conducted prior to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, Misoprostol, Developing countries, Maternal morbidity, Randomized controlled trial