Overview
Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
Status:
Unknown status
Unknown status
Trial end date:
2007-11-01
2007-11-01
Target enrollment:
0
0
Participant gender:
Female
Female
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 bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.Phase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Centers for Disease Control and PreventionCollaborators:
Bill and Melinda Gates Foundation
National Vaccine Program Office
United States Agency for International Development (USAID)Treatments:
Chlorhexidine
Chlorhexidine gluconate
Criteria
Inclusion Criteria:- 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 Criteria:
- 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