Status:
COMPLETED
Chlorhexidine Vaginal and Infant Wash in Pakistan
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:
Sepsis
Pregnancy
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief Summary
Infection is a major health problem during birth in Pakistan. This study will look at the possibility of using a septic wash to help improve health during birth in Karachi, Pakistan.
Detailed Description
Sepsis in mother and infant is a major cause of perinatal morbidity and mortality in low-resource settings. Several studies have investigated the likelihood that an anti-bacterial agent, chlorhexidine...
Eligibility Criteria
Inclusion
- Gravidas with living fetus delivering at home in the care of identified study birth attendant (community) or admitted to the identified hospital (Civil Hospital Karachi) for delivery
Exclusion
- Contraindications to cervical exam (e.g., placenta previa)
- Active genital herpes or vulvovaginal ulceration
- Known or suspected allergy to chlorhexidine
- Fetus with face presentation
- Fetal death
- Unwilling/unable to give informed consent
- Less than 16 years of age
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
5008 Patients enrolled
Trial Details
Trial ID
NCT00121394
Start Date
June 1 2005
End Date
June 1 2008
Last Update
July 31 2014
Active Locations (1)
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1
Civil Hospital Karachi
Karachi, Pakistan