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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

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

Primary Measures

• Postpartum hemorrhage (blood loss >or= 500 mL)
  • Time Frame: Measured at 1 hour postpartum or until active bleeding has stopped
    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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Gijs Walraven, MD Principal Investigator Aga Khan University  

Overall Contact: Jill Durocher, BA 212-448-1230 jdurocher@gynuity.org

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00120237

Study ID Number: 2.4.4

ClinicalTrials.gov Identifier: NCT00120237

Health Authority: Pakistan: Research Ethics Committee

Gynuity Health Projects