Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt

Phase 4

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Misoprostol

• Registration Number: NCT02226588
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Study Start: 2014-10
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2827

Inclusion Criteria

• Willing and able to give informed consent
• Vaginal delivery
• Agrees to participate in follow-up interview
• Agrees to have pre- and post-hemoglobin taken
• Delivery at woman's home or at the primary health unit (PHU)

Exclusion Criteria

• Too advanced into active labor to provide consent
• Known allergy to misoprostol and/or other prostaglandin
• Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secondary prevention	Misoprostol	Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment
Universal prophylaxis	Misoprostol	Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby

Primary Outcome Measures

Name	Time	Method
Mean drop in pre- to post-delivery hemoglobin level	Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.	Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.

Secondary Outcome Measures

Name	Time	Method
Proportion of women diagnosed with PPH	After delivery of the baby up to 24 hours postpartum	PPH will be diagnosed using the standard practices of PHU staff
Proportion of women who receive intervention per protocol	within 2 hours of delivery	To assess feasibility, we will document the proportion of women for whom the intervention arm protocol is correctly followed (including correct timing of drug administration, when necessary).
Proportion of women transferred to higher level care	Following delivery to postpartum visit (2 to 4 days after delivery)	The proportion of women transferred to higher level care will be assessed. Includes the condition of woman at time of transfer and arrival at transfer facility.
Proportion of women receiving additional interventions for PPH	Following delivery to postpartum visit (2 to 4 days after delivery)	An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.
Proportion of women who experience side effects	From time of delivery to 2 hours postpartum	Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed
Proportion of women who find the intervention acceptable	Measured at postpartum visit (2 to 4 days after delivery)	Acceptability will be assessed in an exit interview with women - women will be asked if they are willing to take misoprostol in future deliveries and about the preferences what method they would prefer (primary or secondary prevention) in future deliveries.
Proportion of women experiencing a serious adverse event	Within 2 to 4 days after delivery	Serious adverse events include hysterectomy, blood transfusion, maternal death

Trial Locations

Locations (1)

Primary Health Care Units; 🇪🇬 Kafr El Dawar, El Beheira, Egypt