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Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

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ClinicalTrials.gov Identifier: NCT00120237
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : March 19, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Postpartum Hemorrhage Anemia Drug: Misoprostol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : July 2005
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Intervention Details:
    Drug: Misoprostol
    600 mcg oral misoprostol administered during third stage of labor

Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]
  2. Mean blood loss [ Time Frame: blood loss measured at 1 hr postpartum or until active bleeding stopped ]
  3. Side effects experienced among recently delivered mothers [ Time Frame: Interviews conducted 1 day post-delivery ]
  4. Anemia (<9 g/dL and <11 g/dL) [ Time Frame: Postpartum hemoglobin assessed 3 days post-delivery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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): NCT00120237

Home delivery setting
Chitral, Chitral District, Pakistan
Sponsors and Collaborators
Gynuity Health Projects
Aga Khan University
Aga Khan Health Services
The Aga Khan Foundation
Family Care International
Principal Investigator: Gijs Walraven, MD Aga Khan Health Services
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 Health Services
Study Director: Nadeem Zuberi, MD Aga Khan University
Study Director: Jill Durocher Gynuity Health Projects
More Information

Additional Information:
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00120237     History of Changes
Other Study ID Numbers: 2.4.4
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

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

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