跳至主要内容
临床试验/NCT06072352
NCT06072352尚未招募不适用

A Multicenter Randomized Controlled Trial Comparing Routine Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline to Decrease Maternal and Neonatal Infection

The University of Hong Kong0 个研究点目标入组 3,500 人开始时间: 2023年10月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

相似试验