Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt

Study Overview
=================
Brief Summary
-----------------
This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.

Detailed Description
-----------------
Hospital-based clinical trials have demonstrated misoprostol to be a safe and effective treatment option for postpartum hemorrhage (PPH). Additional research is needed to demonstrate how these findings translate into program effectiveness at lower levels of the health care system, including community home births, where access to skilled providers and treatment options are limited and misoprostol could potentially have the greatest impact on maternal health outcomes. This randomized controlled community treatment trial will assess the effectiveness of misoprostol with standard of care (i.e., referral to higher level care) vs. placebo with standard of care for PPH treatment at the community level, primarily home births attended by primary health care unit staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. This research will help guide decisions on how to introduce misoprostol into PPH care programs in different contexts such as primary care settings, including community-based home births.

Official Title
-----------------
A Randomized Controlled Community Study of the Effectiveness of Misoprostol for PPH Treatment at the Community Level (Home Births Attended by Primary Care Unit Staff) in Etay El Barood and Kafr El Dawar Districts (El Beheira Governorate), Egypt

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Other: Misoprostol + referral
* Other: Placebo + referral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women delivering with provider from participating primary health unit (PHU) willing and able to give informed consent vaginal delivery Exclusion Criteria: women too advanced into active labor to provide informed consent known allergy to misoprostol and/or other prostaglandin women presenting with pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, antepartum hemorrhage, previous complication in the third trimester (should be referred to higher level care for delivery)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>800 mcg sublingual misoprostol + referral to higher level care | Other: Misoprostol + referral<br>* 800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)<br>|
| Placebo Comparator: Placebo<br>Placebo + referral to higher level care | Other: Placebo + referral<br>* Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. | Proportion of women with a change in hemoglobin of >2 g/dL pre- to post-delivery, as measured by the HemoCue machine at both time points. | Before delivery (at onset of labor), after delivery (2 to 4 days after delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women transferred to higher level care | Proportion of women transferred to higher level care will be compared. The condition of the woman at time of transfer and arrival will also be noted. | Within 2 to 4 days after delivery | 
| Proportion of women receiving additional interventions to treat PPH | Proportion of women who receive any additional intervention (e.g. uterotonics, manual removal of placental fragments, bimanual compression, IV fluids given, surgical procedures, blood transfusion, etc.) provided either at deliver site or upon transfer to district hospital. | Within 2 to 4 days after delivery | 
| Proportion of women with side effects | Proportion of women with observed side effects (including shivering/chills, fever, nausea, diarrhea or fainting). Reported severity of side effects (classified by provider as mild, moderate, severe, ), duration of side effects and proportion of of women receiving additional care to manage side effects will also be assessed. | Within 24 hours of delivery | 
| Cost-effectiveness | A cost-effectiveness analysis will be done to compare the two treatment arms. The analysis will factor in the cost of materials used, procedures/interventions performed, transfers, and training of providers. | Within 2 to 4 days after delivery | 
| Proportion of women for whom intervention was correctly administered | Proportion of women for whom treatment was administered as described in protocol (referral initiated and tablets administered to woman after PPH diagnosis made) | Within 1 hour of PPH diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum hemorrhage, treatment, misoprostol, home births