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

2014-08-27 03:52:14 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Infant, Newborn, Diseases

Intervention

Chlorhexidine, Birth canal wipe, sterile water external genital wipe

Location

Chris Hani Baragwanath Hospital
Soweto
Gauteng
South Africa

Status

Recruiting

Source

Centers for Disease Control and Prevention

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:52:14-0400

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