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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

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 Summary: 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.
Sponsor: Centers for Disease Control and Prevention

Current Primary Outcome:

  • Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
  • Rate of vertical transmission of colonization with group B streptococcus (GBS)


Original Primary Outcome:

  • Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
  • Rate of vertical transmission of colonization with GBS


Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Centers for Disease Control and Prevention

Dates:
Date Received: August 25, 2005
Date Started: April 2004
Date Completion: November 2007
Last Updated: September 21, 2007
Last Verified: September 2007