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Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

Primary Purpose

Postpartum Hemorrhage, Anemia

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Misoprostol

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Postpartum hemorrhage, Misoprostol, Maternal morbidity, Developing countries, Traditional birth attendants

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Home delivery setting

Outcomes

Primary Outcome Measures

Postpartum hemorrhage (blood loss >or= 500 mL)

Drop in hemoglobin > 2 g/dL from pre to post-delivery

Secondary Outcome Measures

Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)

Mean blood loss

Side effects experienced among recently delivered mothers

Anemia (<9 g/dL and <11 g/dL)

Full Information

NCT ID

NCT00120237

First Posted

July 7, 2005

Last Updated

March 17, 2009

Sponsor

Gynuity Health Projects

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00120237

Brief Title

Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

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 Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Gynuity Health Projects

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hemorrhage, Anemia

Keywords

Postpartum hemorrhage, Misoprostol, Maternal morbidity, Developing countries, Traditional birth attendants

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1600 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Intervention Description

600 mcg oral misoprostol administered during third stage of labor

Primary Outcome Measure Information:

Title

Postpartum hemorrhage (blood loss >or= 500 mL)

Time Frame

Measured at 1 hour postpartum or until active bleeding has stopped

Title

Drop in hemoglobin > 2 g/dL from pre to post-delivery

Time Frame

Hemoblobin (Hb) level measured 3-5 days after delivery

Secondary Outcome Measure Information:

Title

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

Title

Mean blood loss

Time Frame

blood loss measured at 1 hr postpartum or until active bleeding stopped

Title

Side effects experienced among recently delivered mothers

Time Frame

Interviews conducted 1 day post-delivery

Title

Anemia (<9 g/dL and <11 g/dL)

Time Frame

Postpartum hemoglobin assessed 3 days post-delivery

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: