Status:
COMPLETED
RCT of Misoprostol for Postpartum Hemorrhage in India
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborating Sponsors:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
Conditions:
Postpartum Hemorrhage
Pregnancy
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of m...
Detailed Description
Despite existing knowledge of ways to effectively treat postpartum hemorrhage (PPH), lack of resources in rural India has impeded improvement in rates of maternal mortality and morbidity. Most births ...
Eligibility Criteria
Inclusion
- Gestational age equal to or greater than 28 weeks pregnant
- Planning to deliver at home or at a sub-center in the Belgaum District, Karnataka India
- Anticipating a spontaneous vaginal delivery
- Ability and willingness to provide informed consent
Exclusion
- Previous caesarian section
- Scheduled for caesarian section
- Hemoglobin level less than 8 Gms%
- Episodes of antepartum bleeding during the current pregnancy
- Blood pressure more than 140 mm of Hg systolic and 90 mm of Hg diastolic
- In active labor and not previously screened, recruited, and consented
- Absence of fetal heart sounds
- Multiple pregnancy
- Known history of bronchial asthma
- Prior enrollment in this study during a previous pregnancy
- History of complications (ante/postpartum hemorrhage/retained placenta/ acute inversion of uterus) during a previous pregnancy
- High risk conditions including: diabetes, cardiac ailments, seizures, placenta previa or anticipated breech delivery.
- Receiving injectable medicine at time of delivery
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2005
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00097123
Start Date
September 1 2002
End Date
December 1 2005
Last Update
July 31 2014
Active Locations (1)
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1
KLE Society's Jawaharlal Nehru Medical College
Belagavi, Karnataka, India, 590 010