NCT00136370

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

Preventing Serious Neonatal and Maternal Peripartum Infections in Developing Country Settings With a High Prevalence of HIV Infection: Assessment of the Disease Burden and Evaluation of an Affordable Intervention in Soweto, South Africa

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,000 (estimated)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infant, Newborn, Diseases
• Sepsis
• Puerperal Infection

Interventions

Type	Name	Description
DRUG	Chlorhexidine
PROCEDURE	Birth canal wipe
PROCEDURE	sterile water external genital wipe

Timeline

• Start date: 2004-04-01
• Completion: 2007-11-01
• First posted: 2005-08-29
• Last updated: 2007-09-24

Locations

1 site across 1 country: South Africa