Clinical trial NCT01619072: Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
treatment
misoprostol
home births
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Population, Egypt
name: El Galaa Teaching Hospital
name: Alexandria University
First posted: 2012-06-14
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery.
timeFrame: Before delivery (at onset of labor), after delivery (2 to 4 days after delivery)
Secondary outcomes:
measure: Proportion of women transferred to higher level care
timeFrame: Within 2 to 4 days after delivery
measure: Proportion of women receiving additional interventions to treat PPH
timeFrame: Within 2 to 4 days after delivery
measure: Proportion of women with side effects
timeFrame: Within 24 hours of delivery
measure: Cost-effectiveness
timeFrame: Within 2 to 4 days after delivery
measure: Proportion of women for whom intervention was correctly administered
timeFrame: Within 1 hour of PPH diagnosis
Other outcomes:
Locations:
city: Etay El Barood and Kafr El Dawar districts
country: Egypt
facility: Prinary Health Units
state: El Beheira governorate
Study officials:
affiliation: El Galaa Teaching Hospital
name: Mohamed Cherine Ramadan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant
name: Nevine Hassanein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University Faculy of Medicine
name: Emad Darwish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of health and population
name: Emad Ezzat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.