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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Infant, Newborn, Diseases, Sepsis, Puerperal Infection

Intervention / Treatment
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* Drug: Chlorhexidine
* Procedure: Birth canal wipe
* Procedure: sterile water external genital wipe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Chlorhexidine Vaginal Wipe | Drug: Chlorhexidine<br> <br> Procedure: Birth canal wipe<br> <br> |
| Placebo Comparator: 2<br>Sterile water external genital wipe | Procedure: sterile water external genital wipe<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, Prevention, Neonatal sepsis, Peripartum infections