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Completed

NCT Number: NCT00120237

Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

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.

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Key information

Conditions

Postpartum Hemorrhage Anemia Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Home delivery setting

Chitral, Chitral District, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

600 mcg oral misoprostol administered during third stage of labor

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Aga Khan Health Services
  • Aga Khan University
  • Family Care International
  • The Aga Khan Foundation

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 15, 2005
Registry last updated
Mar 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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