Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.
研究概览
简要总结
When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.
The study will be a prospective randomised trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy
- •normal pregnancy, well dated, at term
- •un ripened cervix
排除标准
- •previous cesarean section
- •multiple pregnancy
- •intra uterine growth restricted fetus
研究组 & 干预措施
double balloon catheter
Cervical ripening by double balloon catheter
干预措施: double balloon catheter (Device)
prostaglandins E2
cervical ripening using prostaglandins E2
干预措施: prostaglandins E2 (Drug)
结局指标
主要结局
Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.
时间窗: during induction of labor, delivery and early post partum
次要结局
- patients satisfaction(induction of labor, delivery and early postpartum)