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Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120237
First Posted: July 15, 2005
Last Update Posted: March 19, 2009
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.
Collaborators:
Aga Khan University
Aga Khan Health Services
The Aga Khan Foundation
Family Care International
Information provided by:
Gynuity Health Projects
  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
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

Resource links provided by NLM:


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

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

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
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
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


Locations
Pakistan
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
Investigators
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 Submitted: July 7, 2005
First Posted: July 15, 2005
Last Update Posted: March 19, 2009
Last Verified: March 2009

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

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