Overview

Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn

Status:
Unknown status
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
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