A Multicenter Randomized Controlled Trial Comparing Routine Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline to Decrease Maternal and Neonatal Infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,500
- 主要终点
- A composite of endometritis, wound infection, or other infection
研究概览
简要总结
Maternal infection during pregnancy is one of the leading causes of maternal mortality, accounting for 10.7% of maternal deaths worldwide (~37,000 annually). Majority of maternal infection occurs during intrapartum (36%) and postpartum (47%) period, of which the genital tract is the source of infection in 89% of intrapartum and 54% of postpartum sepsis.
Introduction of skin flora into the genital tract during vaginal examination in women with rupture of membranes or active labour may cause intrapartum and puerperal sepsis. We hypothesize intrapartum vulval and perineal cleansing before vaginal examination could reduce the chance of peripartum infection caused by introducing the skin flora to intrauterine environment.
We plan to carry out a randomized controlled trial of intrapartum vulval and perineal cleansing using chlorhexidine, compared sterile water, prior to vaginal examination during labour and its effect on maternal and neonatal sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women age ≥ 18 years old
- •Live singleton pregnancy
- •Planned vaginal delivery
- •Term in labour (after 37+0 weeks of gestation)
- •Availability of GBS result at 35-37 weeks
排除标准
- •Preterm delivery (between 24+0 to 36+6 weeks of gestation)
- •Multiple pregnancy
- •Presence of fever before onset of labour
- •History of antibiotics use 7 days before onset of labour
- •History of adverse reaction to chlorhexidine
- •Planned Caesarean delivery
- •Planned delivery in other units
- •Women with autoimmune disease, immunodeficiency, human immunodeficiency virus or on long term steroids
- •Stillbirth
- •Known genital herpes
- •Genital wart during pregnancy
结局指标
主要结局
A composite of endometritis, wound infection, or other infection
时间窗: delivery to within six weeks of delivery
endometritis, wound infection, or other infection
次要结局
未报告次要终点