跳至主要内容
临床试验/NCT05253690
NCT05253690Unknown不适用

Comparing Two Methods for Inserting a Balloon Catheter : View-guided Approach Using a Speculum Versus Manual Guided Approach at Cervical Examination - a Prospective Randomized Trail

Western Galilee Hospital-Nahariya1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
induction to delivery duration

研究概览

简要总结

Induction of labor is a common obstetric procedure. Foley catheter is recommended by WHO for cervical ripening. Insertion is typically speculum guided but digital insertion has been reported to be faster, better tolerated and with similar insertion success rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluated the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score<6.

详细描述

Globally, there has been an increase in birth-induced labor from 9.5% to 29% in the last 3 decades. Circumstances requiring induction include gestational age of 41 weeks or more, hypertension, fetal growth disorder, gestational diabetes and others.

There are different methods of induction, the choice of the best method depends on the bishop score, an estimate based on cervical related data like opening (cm), deletion (%) and other parameters, also the choice of induction method depends on the obstetric history of the mother. Bishop score less than 6, indicates an immature cervix, and therefore increases the chance of induction failure.

The mechanism by which the catheter works includes a mechanical effect that causes the cervix to dilate, but in addition the direct stress on the inner surface of the cervix tissue and lower segment of the uterus indirectly causes local secretion of prostoglandins which help softening the cervix and may induce contractions.

Inserting a single or double balloon catheter, is traditionally performed in a lithotomy position, and after inserting a speculum, disinfecting with polydine, identifying the external os of the cervix and then inserting the catheter, inflating the balloon with saline up to 30-80 ml while looking at the position of the balloon.

Insertion of the catheter is typically speculum guided, but digital insertion has been reported to be faster, better tolerated and with similar insertion success and infections rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluate the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score<6.

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
Single (Outcomes Assessor)

盲法说明

The obstetrician evaluating labor progress is blinded for type of intervention

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Singelton parous women Term pregnancy Vertex position

排除标准

  • •Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly

研究组 & 干预措施

speculum guided

Active Comparator

view-guided approach using a speculum

干预措施: balloon catheter insertion approach for labor induction (Procedure)

manual guided

Experimental

manual guided approach at cervical examination

干预措施: balloon catheter insertion approach for labor induction (Procedure)

结局指标

主要结局

induction to delivery duration

时间窗: through study completion, an average of 1 year

hours

Maternal pain sensation during the procedure

时间窗: during the procedure

VAS (visual analog scale) SCORE scale 0-10 0-better outcome 10-worse outcome

次要结局

  • catheter insertion duration(during the procedure)
  • chorioamnionitis- fever during labor(during labor up to 48 hours)
  • maternal satisfaction- questionnaire(during one hour after the procedure)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Maya Wolf

Director of fetal maternal unit

Western Galilee Hospital-Nahariya

研究点 (1)

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