Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02226588
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : February 15, 2016
Sponsor:
Collaborators:
Ministry of Health and Population, Egypt
University of Alexandria
El Galaa Teaching Hospital
Information provided by (Responsible Party):
Gynuity Health Projects

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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2827 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Secondary prevention
Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment
Drug: Misoprostol
Active Comparator: Universal prophylaxis
Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby
Drug: Misoprostol



Primary Outcome Measures :
  1. Mean drop in pre- to post-delivery hemoglobin level [ Time Frame: 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. ]
    Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.


Secondary Outcome Measures :
  1. Proportion of women transferred to higher level care [ Time Frame: Following delivery to postpartum visit (2 to 4 days after delivery) ]
    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.

  2. Proportion of women diagnosed with PPH [ Time Frame: After delivery of the baby up to 24 hours postpartum ]
    PPH will be diagnosed using the standard practices of PHU staff

  3. Proportion of women receiving additional interventions for PPH [ Time Frame: Following delivery to postpartum visit (2 to 4 days after delivery) ]
    An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.

  4. Proportion of women who experience side effects [ Time Frame: From time of delivery to 2 hours postpartum ]
    Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed

  5. Proportion of women who find the intervention acceptable [ Time Frame: Measured at postpartum visit (2 to 4 days after delivery) ]
    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.

  6. Proportion of women who receive intervention per protocol [ Time Frame: within 2 hours of delivery ]
    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).

  7. Proportion of women experiencing a serious adverse event [ Time Frame: Within 2 to 4 days after delivery ]
    Serious adverse events include hysterectomy, blood transfusion, maternal death



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226588


Locations
Layout table for location information
Egypt
Primary Health Care Units
Damanhour, El Beheira, Egypt
Primary Health Care Units
Kafr El Dawar, El Beheira, Egypt
Sponsors and Collaborators
Gynuity Health Projects
Ministry of Health and Population, Egypt
University of Alexandria
El Galaa Teaching Hospital
Investigators
Layout table for investigator information
Principal Investigator: Nevine Hassanein, MD Consultant
Principal Investigator: Emad Darwish, MD Alexandria University
Principal Investigator: Mohamed Cherine, MD El Galaa Teaching Hospital
Principal Investigator: Rasha Dabash, MPH Gynuity Health Projects
Principal Investigator: Holly Anger, MPH Gynuity Health Projects

Additional Information:
Layout table for additonal information
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02226588     History of Changes
Other Study ID Numbers: 3004
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016

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