NCT03442218已完成不适用
Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.
Saint Thomas Hospital, Panama1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Number of cases of endometritis after cesarean section
研究概览
简要总结
To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with gestation between 34 and 41 6/7 weeks.
- •Premature rupture of membranes (> 6 hours).
- •Use of prophylactic antibiotic 1 hour previous to cesarean section.
排除标准
- •Any source of infection diagnosed previous to surgery.
- •Fever of unknown origin previous to surgery.
研究组 & 干预措施
Clorhexidine
Experimental
Vaginal wash with clorhexidine solution
干预措施: Clorhexidine (Drug)
Saline solution
Placebo Comparator
Vaginal wash with saline solution
干预措施: Saline solution (Drug)
结局指标
主要结局
Number of cases of endometritis after cesarean section
时间窗: 15 days
Endometritis
次要结局
- Number of cases of fever (38°C or above) in the puerperium(15 days)
- Number of cases of cesarean site infection(15 days)
研究者
Osvaldo A. Reyes T.
Head - Research Department
Saint Thomas Hospital, Panama
研究点 (1)
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