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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
8,000
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa
RECRUITINGRates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
Rate of vertical transmission of colonization with group B streptococcus (GBS)
Rates of culture-confirmed or clinical neonatal sepsis (non-nosocomial), 3 to 28 days of life
Rates of serious maternal per partum infections including: endometritis, culture-confirmed post-partum sepsis, and post-partum perineal wound infection
Rates of neonatal hospitalization, < 3 days of life
Rates of neonatal hospitalization, < 28 days of life
Rates of neonatal hospitalization, suspected sepsis
Rate of vertical transmission of colonization with E. coli or Klebsiella species
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