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

NCT ID: NCT01619072

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Postpartum Hemorrhage

Keywords

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postpartum hemorrhage treatment misoprostol home births

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Misoprostol

800 mcg sublingual misoprostol + referral to higher level care

Group Type ACTIVE_COMPARATOR

Misoprostol + referral

Intervention Type OTHER

800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)

Placebo

Placebo + referral to higher level care

Group Type PLACEBO_COMPARATOR

Placebo + referral

Intervention Type OTHER

Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)

Interventions

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Misoprostol + referral

800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)

Intervention Type OTHER

Placebo + referral

Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health and Population, Egypt

OTHER_GOV

Sponsor Role collaborator

El Galaa Teaching Hospital

OTHER

Sponsor Role collaborator

Alexandria University

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Cherine Ramadan, MD

Role: PRINCIPAL_INVESTIGATOR

El Galaa Teaching Hospital

Nevine Hassanein, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Emad Darwish, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University Faculy of Medicine

Emad Ezzat, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of health and population

Rasha Dabash, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Prinary Health Units

Etay El Barood and Kafr El Dawar Districts, Beheira, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 33232518 (View on PubMed)

Related Links

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http://www.gynuity.org

Related Info

Other Identifiers

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3001

Identifier Type: -

Identifier Source: org_study_id