Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births

Study Overview
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Brief Summary
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Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use. A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta. Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.

Official Title
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Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.

Conditions
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Postpartum Hemorrhage (PPH)

Intervention / Treatment
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* Other: placebo
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women must be pregnant Must be able to provide informed consent Must agree to have a community health worker present at the time of delivery Must agree to participate in a follow up interview by the study midwife Must agree to have pre and postpartum haemoglobin taken Exclusion Criteria: Women who do not meet the inclusion criteria
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: misoprostol<br>800mcg misoprostol (four tablets of 200 mcg administered sublingually) | Drug: Misoprostol<br>* 800mcg misoprostol (4 200mcg tablets administered sublingually)<br>|
| Placebo Comparator: placebo<br>4 placebo tablets (resembling misoprostol) administered sublingually | Other: placebo<br>* 4 placebo tablets (resembling misoprostol) administered sublingually<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb of greater than or equal to 2 g/dl from pre- to post-delivery | The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups. | 3-5 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths. | immediately after delivery; 3-5 days post delivery | 
| additional interventions | Additional interventions and additional care provided to the woman, # of referrals and transfers | immediately after delivery; 3-5 days post delivery | 
| Acceptability | Acceptability and management of side effects, acceptablity of taking the drugs | immediately after delivery; 3-5 days post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, PPH, misoprostol, home deliveries