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
试验速览
- 阶段
- 3 期
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Chlorhexidine Vaginal Wipe
干预措施: Chlorhexidine (Drug)
1
Chlorhexidine Vaginal Wipe
干预措施: Birth canal wipe (Procedure)
2
Sterile water external genital wipe
干预措施: sterile water external genital wipe (Procedure)
结局指标
主要结局
Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
Rate of vertical transmission of colonization with group B streptococcus (GBS)
次要结局
- 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