Misoprostol in the Treatment of Postpartum Hemorrhage

Study Overview
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Brief Summary
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Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.

Official Title
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Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals

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: All women delivering vaginally with clinically diagnosed PPH requiring uterotonics Exclusion Criteria: Refusal to give consent for participation or if the woman is too distressed to give consent Woman is not entitled to give informed consent (e.g. minors without a guardian) Woman who had a caesarean section Delivery is regarded as abortion (gestational age < 28 weeks)
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>three tablets of active misoprostol (600 mcg) given sublingually | Drug: Misoprostol<br>* 600 mcg of sublingual misoprostol<br>|
| Placebo Comparator: Placebo<br>three tablets resembling misoprostol given sublingually | Drug: Misoprostol<br>* 600 mcg of sublingual misoprostol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss greater than or equal to 500 mls after enrolment |  | Blood loss measured for minimum of 1 hour or until active bleeding ceased | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average blood loss |  | Blood loss measured for minimum of one hour or until active bleeding ceased | 
| Clinical complications (need for transfusion, hysterectomy) |  | After delivery and prior to hospital discharge | 
| Pre-delivery and post-delivery hemoglobin measures |  | Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery | 
| Side effects |  | observed or reported following study treatment and prior to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Haemorrhage, Misoprostol