Infant, Newborn, Diseases, Puerperal Infection, Sepsis
Conditions
Keywords
Chlorhexidine, Prevention, Neonatal sepsis, Peripartum infections
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 bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.
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 reducing 1) vertical transmission of leading pathogenic bacteria from mother to child during labour and delivery, and 2) incidence of neonatal sepsis and maternal peripartum infection, in comparison to external genitalia sterile water wipes. In conjunction with this, we will compare vaginal carriage of bacteria commonly associated with neonatal sepsis and maternal peripartum infection among HIV-infected and non-infected pregnant women who deliver at the only public hospital in Soweto, and will characterize the burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in this population by conducting active prospective surveillance.
Interventions
DRUGChlorhexidine
PROCEDUREBirth canal wipe
PROCEDUREsterile water external genital wipe
Sponsors
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
National Vaccine Program Office
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life | — |
| Rate of vertical transmission of colonization with group B streptococcus (GBS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of neonatal hospitalization, < 3 days of life | — |
| Rates of neonatal hospitalization, < 28 days of life | — |
| Rates of culture-confirmed or clinical neonatal sepsis (non-nosocomial), 3 to 28 days of life | — |
| Rate of vertical transmission of colonization with E. coli or Klebsiella species | — |
| Rates of neonatal hospitalization, suspected sepsis | — |
| Rates of serious maternal per partum infections including: endometritis, culture-confirmed post-partum sepsis, and post-partum perineal wound infection | — |
Countries
South Africa
Contacts
Primary ContactClare Cutland, BSc, MBBCh
Backup ContactShabir Madhi, MD, PhD
Outcome results
None listed