Clinical trial NCT02226588: Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Population, Egypt
name: University of Alexandria
name: El Galaa Teaching Hospital
First posted: 2014-08-27
Enrollment: 2827
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean drop in pre- to post-delivery hemoglobin level
timeFrame: 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.
Secondary outcomes:
measure: Proportion of women transferred to higher level care
timeFrame: Following delivery to postpartum visit (2 to 4 days after delivery)
measure: Proportion of women diagnosed with PPH
timeFrame: After delivery of the baby up to 24 hours postpartum
measure: Proportion of women receiving additional interventions for PPH
timeFrame: Following delivery to postpartum visit (2 to 4 days after delivery)
measure: Proportion of women who experience side effects
timeFrame: From time of delivery to 2 hours postpartum
measure: Proportion of women who find the intervention acceptable
timeFrame: Measured at postpartum visit (2 to 4 days after delivery)
measure: Proportion of women who receive intervention per protocol
timeFrame: within 2 hours of delivery
measure: Proportion of women experiencing a serious adverse event
timeFrame: Within 2 to 4 days after delivery
Other outcomes:
Locations:
city: Damanhour
country: Egypt
facility: Primary Health Care Units
state: El Beheira
city: Kafr El Dawar
country: Egypt
facility: Primary Health Care Units
state: El Beheira
Study officials:
affiliation: Consultant
name: Nevine Hassanein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Emad Darwish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: El Galaa Teaching Hospital
name: Mohamed Cherine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Holly Anger, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anger HA, Dabash R, Hassanein N, Darwish E, Ramadan MC, Nawar M, Charles D, Breebaart M, Winikoff B. A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt. BMC Pregnancy Childbirth. 2020 May 24;20(1):317. doi: 10.1186/s12884-020-03008-5.