Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120237
• Other study ID #: 2.4.4
• Status: Completed
• Phase: N/A
• First received: July 7, 2005
• Last updated: March 17, 2009
• Start date: July 2005
• Est. completion date: July 2008

Study information

• Verified date: March 2009
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Pakistan	Home delivery setting	Chitral	Chitral District

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	Aga Khan Health Services, Aga Khan University, Family Care International, The Aga Khan Foundation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum hemorrhage (blood loss >or= 500 mL)		Measured at 1 hour postpartum or until active bleeding has stopped	Yes
Primary	Drop in hemoglobin > 2 g/dL from pre to post-delivery		Hemoblobin (Hb) level measured 3-5 days after delivery	Yes
Secondary	Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)		Blood loss measured at 1 hr postpartum or until active bleeding stopped	Yes
Secondary	Mean blood loss		blood loss measured at 1 hr postpartum or until active bleeding stopped	Yes
Secondary	Side effects experienced among recently delivered mothers		Interviews conducted 1 day post-delivery	Yes
Secondary	Anemia (<9 g/dL and <11 g/dL)		Postpartum hemoglobin assessed 3 days post-delivery	Yes

External Links

•   Gynuity Health Projects