NCT03064672Unknown不适用
Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- adverse neonatal outcomes
研究概览
简要总结
This prospective cohort study aims to determine whether maternal and neonatal outcomes are affected by GBS carrier status in women undergoing transcervical balloon catheter insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •During the study period and in the absence of contraindications, women anticipating induction of labor with unripe cervix will be screened for eligibility.
- •Inclusion criteria are singleton gestation with confirmed cephalic presentation
- •Gestational age between 37+0/7 and 41+6/7 weeks'
- •Intact membranes
- •Reactive non-stress test and Bishop's score < 6.
排除标准
- •Women less than 18 years, with multiple gestation pregnancies, pregnancies with major fetal anomalies, vaginal infection, intrauterine fetal death and those who were not candidates for vaginal delivery (placenta previa, non-cephalic presentation, planned cesarean delivery).
结局指标
主要结局
adverse neonatal outcomes
时间窗: 2-3 days
the incidence of composite adverse neonatal outcomes based on the NICE criteria for early detection of neonatal sepsis
次要结局
- composite adverse maternal outcomes(2-3 days)
研究者
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