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

Centers for Disease Control and Prevention (CDC)

Status and phase: Unknown; Phase 3

Conditions: Infant, Newborn, Diseases; Puerperal Infection; Sepsis

Treatments: Procedure: Birth canal wipe; Procedure: sterile water external genital wipe; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00136370

CDC-NCID-3842

#U50 CCU021960, 02075

RFA CI05-059

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8,000 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Chlorhexidine Vaginal Wipe

Treatment:

Drug: Chlorhexidine

Procedure: Birth canal wipe

2

Placebo Comparator group

Description:

Sterile water external genital wipe

Treatment:

Procedure: sterile water external genital wipe