Status:
UNKNOWN
Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Conditions:
Infant, Newborn, Diseases
Sepsis
Eligibility:
FEMALE
15+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacte...
Detailed Description
We are conducting a randomized, controlled clinical trial in Soweto, South Africa to evaluate the efficacy of 0.5% chlorhexidine wipes of the birth canal during labour and of the infant at birth in re...
Eligibility Criteria
Inclusion
- Pregnant
- Plan to deliver at Chris Hani Baragwanath Hospital or one of its satellite clinics
- Plan to remain in Soweto for at least two months after delivery
- Are able to understand and give informed consent
- Are at least 15 years old at time of registration
Exclusion
- Planned delivery by caesarean section
- Antenatal ultrasound revealing major fetal congenital anomalies
- Have known or suspected condition in which vaginal exams are contraindicated, e.g. placenta previa
- Have a history of allergic reaction to any topical antiseptic solution
- Present to labour ward with infant born before arrival
- Present to labour ward with significant vaginal bleeding during labour
- Present with known intrauterine fetal death prior to randomization
- Subject noted to be in full cervical dilatation or have baby's head on perineum
- Infant noted to be in face presentation on first vaginal examination
- Noted to have genital ulcers present on first vaginal examination
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
8000 Patients enrolled
Trial Details
Trial ID
NCT00136370
Start Date
April 1 2004
End Date
November 1 2007
Last Update
September 24 2007
Active Locations (1)
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1
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa