Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
Recruitment status was Recruiting
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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 |
- Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
- Rate of vertical transmission of colonization with group B streptococcus (GBS)
- 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.
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Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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
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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 | |
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 |
Principal Investigator: | Stephanie Schrag, DPhil | Centers for Disease Control and Prevention |
Principal Investigator: | Shabir Madhi, MD, PhD | Respiratory and Meningeal Pathogens Research Unit |
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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:
Infant, Newborn, Diseases Puerperal Infection Sepsis Toxemia Pregnancy Complications, Infectious Infection Pregnancy Complications Puerperal Disorders Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on March 14, 2013