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

Postpartum Hemorrhage Clinical Trial

Official title:

Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226588
• Other study ID #: 3004
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2014
• Last updated: February 12, 2016
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2827
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
Egypt	Primary Health Care Units	Damanhour	El Beheira
Egypt	Primary Health Care Units	Kafr El Dawar	El Beheira

Sponsors (4)

Lead Sponsor	Collaborator
Gynuity Health Projects	El Galaa Teaching Hospital, Faculty of Medicine, Alexandria University, Ministry of Health and Population of Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean drop in pre- to post-delivery hemoglobin level	Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.	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.	No
Secondary	Proportion of women transferred to higher level care	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.	Following delivery to postpartum visit (2 to 4 days after delivery)	No
Secondary	Proportion of women diagnosed with PPH	PPH will be diagnosed using the standard practices of PHU staff	After delivery of the baby up to 24 hours postpartum	No
Secondary	Proportion of women receiving additional interventions for PPH	An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.	Following delivery to postpartum visit (2 to 4 days after delivery)	No
Secondary	Proportion of women who experience side effects	Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed	From time of delivery to 2 hours postpartum	Yes
Secondary	Proportion of women who find the intervention acceptable	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.	Measured at postpartum visit (2 to 4 days after delivery)	No
Secondary	Proportion of women who receive intervention per protocol	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).	within 2 hours of delivery	No
Secondary	Proportion of women experiencing a serious adverse event	Serious adverse events include hysterectomy, blood transfusion, maternal death	Within 2 to 4 days after delivery	Yes

External Links

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