Myometrial Biopsy for the Detection of Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Postoperative infection following rupture of amniotic membranes
研究概览
简要总结
This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.
详细描述
The infection is a dynamic process probably beginning shortly after the onset of labor. This process continues and is enhanced during active uterine contractions, which result in bacteria from the vagina being drawn up into the uterine cavity. During labor, bacterial colonization of the amniotic fluid, the decidua, and even the fetus can occur, resulting in infection of the mother and the fetus.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients must be afebrile throughout labor.
- •Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
- •Patients undergoing an elective cesarean section.
- •Patients who have labored with intact or ruptured amniotic membranes.
排除标准
- •Patient with a temperature of ≥ 100.4o F.
- •White blood cell count ≥ 24,
- •Suspicion of chorioamnionitis.
- •Suspicion of a urinary tract infection.
- •Presence of diarrhea (defined > 4 liquid stools in a 24 hour period).
- •Patient currently taking therapeutic antibiotics.
研究组 & 干预措施
Group 1
Patients who have labored and subsequently delivered by cesarean section
干预措施: Biopsy (Procedure)
2
Patients who electively select cesarean section
干预措施: Biopsy (Procedure)
结局指标
主要结局
Postoperative infection following rupture of amniotic membranes
时间窗: Amount of time it takes to obtain culture result
次要结局
未报告次要终点