Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn (NCT00136370) | Clinical Trial Compass
UnknownPhase 3
Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
South Africa8,000 participantsStarted 2004-04
Plain-language 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.
Who can participate
Age range
15 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
2
Rate of vertical transmission of colonization with group B streptococcus (GBS)