Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening in Postdate Primigravidae
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Cervical Ripening by using Foley's Catheter
研究概览
简要总结
Cervical ripening should be present before labor induction, which can generally be divided into two categories: pharmacological and mechanical
详细描述
With appropriate decision and timely intervention, labor induction decreases the risk of fetal and maternal morbidity and mortality. The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanicalwith a minimal increase in risk of cesarean section.
The single balloon catheter (i.e. Foley catheter [FC]) and Cook cervical ripening balloon have been the most commonly used mechanical method.
The FC applies pressure on lower uterine segment and cervix in the direction from the uterus to the vagina.
The Cook cervical ripening balloon is composed of a cervicovaginal balloon and a uterine balloon. Its mechanism is similar to that of the Foley balloon, but it can apply pressure in two directions simultaneously, on both the external and internal os.
Although many studies have shown that the Cook cervical ripening balloon and FC have similar efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age from 18 to 34 years old
- •Postdate Primigravida
- •Single viable fetus.
- •Cephalic presentation.
- •Normal biophysical .
- •Bishop score of four or less.
- •RH positive women.
排除标准
- •Premature rupture of membranes (PROM).
- •Oligo or Polyhydramnios
- •Antepartum hemorrhage and placenta praevia.
- •Current cervical cerclage.
- •Invasive cervical carcinoma.
- •Known fetal anomaly.
- •Previous uterine scar due to myomectomy or metroplasty.
- •Cephalopelvic disproportion due to pelvic contraction or Macrosomic baby.
- •Active genital Herpes infection.
- •Chronic maternal illness.
结局指标
主要结局
Cervical Ripening by using Foley's Catheter
时间窗: from 0 hours to 4 hours after induction of labour
To compare the efficacy of two mechanical devices as single and double Foley's catheter for pre-induction of labor by making cervical ripening in primigravidae whom delayed on the expected date of delivery
次要结局
未报告次要终点