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

Study Overview
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Brief Summary
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A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.

Detailed Description
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A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level. The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.

Official Title
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Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births

Conditions
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Postpartum Haemorrhage

Intervention / Treatment
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* Drug: Misoprostol
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who deliver at home with a study TBA present. Women must be willing and able to provide informed consent Women must agree to participate in a follow up interview Women must agree to have pre and post-partum haemoglobin taken Exclusion Criteria: If the woman does not meet any of the above outlined 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>women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually) | Drug: Misoprostol<br>* 4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth<br>* Other names: Gymiso;|
| Placebo Comparator: placebo<br>women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually | Other: placebo<br>* 4 tablets, administered sublingually if the woman experiences a PPH<br>* Other names: Gymiso;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin concentration (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. | 3-5 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience side effects | number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided | immediately after delivery; 3-5 days post delivery | 
| number of participants who received additional interventions | number of participants who received care by as skilled provider and the type of care provided | immediately after delivery; 3-5 days post delivery | 
| number of women who found misoprostol treatment to be acceptable | women will be asked to rate their acceptability with the treatment using a scale | immediately after delivery; 3-5 days post delivery | 
| number of participants who experience severe adverse events | serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths. | 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 haemorrhage, misoprostol, treatment, prophylaxis, home births