Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan

A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120237

Enrollment

1600

Registered

2005-07-15

Start date

2005-07-31

Completion date

2008-07-31

Last updated

2009-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Postpartum Hemorrhage

Keywords

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

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.

Interventions

DRUGMisoprostol

600 mcg oral misoprostol administered during third stage of labor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Postpartum hemorrhage (blood loss >or= 500 mL)	Measured at 1 hour postpartum or until active bleeding has stopped
Drop in hemoglobin > 2 g/dL from pre to post-delivery	Hemoblobin (Hb) level measured 3-5 days after delivery

Secondary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026