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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Centers for Disease Control and Prevention.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
National Vaccine Program Office
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00136370
First received: August 25, 2005
Last updated: September 21, 2007
Last verified: September 2007

August 25, 2005
September 21, 2007
April 2004
Not Provided
  • Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
  • Rate of vertical transmission of colonization with group B streptococcus (GBS)
Same as current
Complete list of historical versions of study NCT00136370 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Infant, Newborn, Diseases
  • Sepsis
  • Puerperal Infection
  • Drug: Chlorhexidine
  • Procedure: Birth canal wipe
  • Procedure: sterile water external genital wipe
  • Experimental: 1
    Chlorhexidine Vaginal Wipe
    Interventions:
    • Drug: Chlorhexidine
    • Procedure: Birth canal wipe
  • Placebo Comparator: 2
    Sterile water external genital wipe
    Intervention: Procedure: sterile water external genital wipe

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8000
November 2007
Not Provided

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
Female
15 Years and older
Yes
Contact: Clare Cutland, BSc, MBBCh +27-11-989-9894 cutlandc@hivsa.com
Contact: Shabir Madhi, MD, PhD +27-11-989-9894 madhis@hivsa.com
South Africa
 
NCT00136370
CDC-NCID-3842, #U50 CCU021960, 02075, RFA CI05-059
Yes
Not Provided
Centers for Disease Control and Prevention
  • Bill and Melinda Gates Foundation
  • United States Agency for International Development (USAID)
  • National Vaccine Program Office
Principal Investigator: Stephanie Schrag, DPhil Centers for Disease Control and Prevention
Principal Investigator: Shabir Madhi, MD, PhD Respiratory and Meningeal Pathogens Research Unit
Centers for Disease Control and Prevention
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP