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
  Purpose

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.


Condition Intervention Phase
Infant, Newborn, Diseases
Sepsis
Puerperal Infection
Drug: Chlorhexidine
Procedure: Birth canal wipe
Procedure: sterile water external genital wipe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Intervention in Soweto, South Africa

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 8000
Study Start Date: April 2004
Estimated Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1
Chlorhexidine Vaginal Wipe
Drug: Chlorhexidine Procedure: Birth canal wipe
Placebo Comparator: 2
Sterile water external genital wipe
Procedure: sterile water external genital wipe

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136370

Contacts
Contact: Clare Cutland, BSc, MBBCh +27-11-989-9894 cutlandc@hivsa.com
Contact: Shabir Madhi, MD, PhD +27-11-989-9894 madhis@hivsa.com

Locations
South Africa
Chris Hani Baragwanath Hospital Recruiting
Soweto, Gauteng, South Africa
Contact: Shabir Madhi, MD, PhD    +27-11-989-9894    madhis@hivsa.com   
Contact: Clare Cutland, BSc, MBBCh    +27-11-989-9894    cutlandc@hivsa.com   
Principal Investigator: Shabir Madhi, MD, PhD         
Sub-Investigator: Clare Cutland, BSc, MBBCh         
Sub-Investigator: Sithembiso Velaphi, MB         
Sponsors and Collaborators
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
National Vaccine Program Office
Investigators
Principal Investigator: Stephanie Schrag, DPhil Centers for Disease Control and Prevention
Principal Investigator: Shabir Madhi, MD, PhD Respiratory and Meningeal Pathogens Research Unit
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00136370     History of Changes
Other Study ID Numbers: CDC-NCID-3842, #U50 CCU021960, 02075, RFA CI05-059
Study First Received: August 25, 2005
Last Updated: September 21, 2007
Health Authority: United States: Federal Government
South Africa: University of Witwatersrand Human Research Ethics Committee (Medical)

Keywords provided by Centers for Disease Control and Prevention:
Chlorhexidine
Prevention
Neonatal sepsis
Peripartum infections

Additional relevant MeSH terms:
Communicable Diseases
Infant, Newborn, Diseases
Infection
Puerperal Infection
Sepsis
Toxemia
Inflammation
Pathologic Processes
Pregnancy Complications
Pregnancy Complications, Infectious
Puerperal Disorders
Systemic Inflammatory Response Syndrome
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014