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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health and Population, Egypt
El Galaa Teaching Hospital
Alexandria University
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01619072
First received: June 12, 2012
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Other: Misoprostol + referral
Other: Placebo + referral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. [ Time Frame: Before delivery (at onset of labor), after delivery (2 to 4 days after delivery) ] [ Designated as safety issue: No ]
    Proportion of women with a change in hemoglobin of >2 g/dL pre- to post-delivery, as measured by the HemoCue machine at both time points.


Secondary Outcome Measures:
  • Proportion of women transferred to higher level care [ Time Frame: Within 2 to 4 days after delivery ] [ Designated as safety issue: No ]
    Proportion of women transferred to higher level care will be compared. The condition of the woman at time of transfer and arrival will also be noted.

  • Proportion of women receiving additional interventions to treat PPH [ Time Frame: Within 2 to 4 days after delivery ] [ Designated as safety issue: Yes ]
    Proportion of women who receive any additional intervention (e.g. uterotonics, manual removal of placental fragments, bimanual compression, IV fluids given, surgical procedures, blood transfusion, etc.) provided either at deliver site or upon transfer to district hospital.

  • Proportion of women with side effects [ Time Frame: Within 24 hours of delivery ] [ Designated as safety issue: Yes ]
    Proportion of women with observed side effects (including shivering/chills, fever, nausea, diarrhea or fainting). Reported severity of side effects (classified by provider as "mild, "moderate," "severe," ), duration of side effects and proportion of of women receiving additional care to manage side effects will also be assessed.

  • Cost-effectiveness [ Time Frame: Within 2 to 4 days after delivery ] [ Designated as safety issue: No ]
    A cost-effectiveness analysis will be done to compare the two treatment arms. The analysis will factor in the cost of materials used, procedures/interventions performed, transfers, and training of providers.

  • Proportion of women for whom intervention was correctly administered [ Time Frame: Within 1 hour of PPH diagnosis ] [ Designated as safety issue: Yes ]
    Proportion of women for whom treatment was administered as described in protocol (referral initiated and tablets administered to woman after PPH diagnosis made)


Enrollment: 82
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol
800 mcg sublingual misoprostol + referral to higher level care
Other: Misoprostol + referral
800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)
Placebo Comparator: Placebo
Placebo + referral to higher level care
Other: Placebo + referral
Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619072

Locations
Egypt
Prinary Health Units
Etay El Barood and Kafr El Dawar districts, El Beheira governorate, Egypt
Sponsors and Collaborators
Gynuity Health Projects
Ministry of Health and Population, Egypt
El Galaa Teaching Hospital
Alexandria University
Investigators
Principal Investigator: Mohamed Cherine Ramadan, MD El Galaa Teaching Hospital
Principal Investigator: Nevine Hassanein, MD Consultant
Principal Investigator: Emad Darwish, MD Alexandria University Faculy of Medicine
Principal Investigator: Emad Ezzat, MD Ministry of Health and Population
Principal Investigator: Rasha Dabash, MPH Gynuity Health Projects
  More Information

Additional Information:
No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01619072     History of Changes
Other Study ID Numbers: 3001
Study First Received: June 12, 2012
Last Updated: November 21, 2013
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Gynuity Health Projects:
postpartum hemorrhage
treatment
misoprostol
home births

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 28, 2014