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Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

This study has been completed.
Sponsor:
Collaborators:
Aga Khan University
The Aga Khan Health Services, Pakistan
The Aga Khan Foundation, Aiglemont, France
Family Care International
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00120237
First received: July 7, 2005
Last updated: March 17, 2009
Last verified: March 2009
History of Changes
  Purpose

This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.


Condition Intervention
Postpartum Hemorrhage
Anemia
 Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan

Resource links provided by NLM:

Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Postpartum hemorrhage (blood loss >or= 500 mL) [ Time Frame: Measured at 1 hour postpartum or until active bleeding has stopped ] [ Designated as safety issue: Yes ]
  • Drop in hemoglobin > 2 g/dL from pre to post-delivery [ Time Frame: Hemoblobin (Hb) level measured 3-5 days after delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL) [ Time Frame: Blood loss measured at 1 hr postpartum or until active bleeding stopped ] [ Designated as safety issue: Yes ]
  • Mean blood loss [ Time Frame: blood loss measured at 1 hr postpartum or until active bleeding stopped ] [ Designated as safety issue: Yes ]
  • Side effects experienced among recently delivered mothers [ Time Frame: Interviews conducted 1 day post-delivery ] [ Designated as safety issue: Yes ]
  • Anemia (<9 g/dL and <11 g/dL) [ Time Frame: Postpartum hemoglobin assessed 3 days post-delivery ] [ Designated as safety issue: Yes ]

Enrollment: 1600
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Misoprostol
    600 mcg oral misoprostol administered during third stage of labor
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women in general good health, home delivery
  • Must live in one of 78 study villages

Exclusion Criteria:

  • Hypertension
  • Non-cephalic presentation
  • Polyhydramnios
  • Previous cesarean section
  • Suspected multiple pregnancy
  • Suspected still birth
  • Antepartum hemorrhage
  • Previous complication in 3rd trimester
  • Anemia of <8 g/dl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120237

Locations
Pakistan
Home delivery setting
Chitral, Chitral District, Pakistan
Sponsors and Collaborators
Gynuity Health Projects
Aga Khan University
The Aga Khan Health Services, Pakistan
The Aga Khan Foundation, Aiglemont, France
Family Care International
Investigators
Principal Investigator: Gijs Walraven, MD Aga Khan University
Principal Investigator: Juanita Hatcher, PhD Aga Khan University
Study Director: Naushaba Mobeen, MD Aga Khan University
Study Director: Jennifer Blum, MPH Gynuity Health Projects
Study Director: Zafar Ahmad, MD Aga Khan University
Study Director: Nadeem Zuberi, MD Aga Khan University
Study Director: Jill Durocher Gynuity Health Projects
  More Information

Additional Information:
Gynuity Health Projects  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00120237     History of Changes
Other Study ID Numbers: 2.4.4
Study First Received: July 7, 2005
Last Updated: March 17, 2009
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Gynuity Health Projects:
Postpartum hemorrhage
Misoprostol
Maternal morbidity
Developing countries
Traditional birth attendants

Additional relevant MeSH terms:
Anemia
Hemorrhage
Postpartum Hemorrhage
Hematologic Diseases
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 May 16, 2013