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临床试验/NCT04216628
NCT04216628终止不适用

Early Versus Late Amniotomy Following EAB Cervical Ripening - Does Parity Matter?

Assuta Ashdod Hospital1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2020年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
146
试验地点
1
主要终点
Delivery within 24 hours

研究概览

简要总结

The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.

详细描述

Induction of labor is a common obstetric procedure with a reported rate of 23.3% in 2012 in the United State. It has been recently reported that Induction of labor at full term in uncomplicated singleton gestations is not associated with increased risk of cesarean delivery and overall has similar outcomes compared to expectant management.

Induction of labor in women with an unripened cervix is comprised of two stages, cervical ripening followed by augmentation of labor.

Extra amniotic balloon inflation is a widespread mechanical method of cervical ripening that commonly results in a ripened cervix open to 3-4 cm without significant uterine contractions. At this point the clinician may opt to perform artificial rupture of membranes or rather first begin oxytocin infusion delaying amniotomy to later stages of labor. A retrospective cohort showed early amniotomy after Foley balloon catheter removal was associated with shorter duration of labor induction among nulliparous women.In accordance, an RCT investigating the efficacy of early amniotomy in nulliparous women showed this practice resulted in labor shortening without increasing the rate of cesarean section, yet these women were treated by different methods for cervical ripening. Contradicting results were shown in a randomized controlled trial addressing the very question of early versus late amoniotomy after balloon ripening, concluding that postponing amniotomy until active labor commences results in a reduction of dystocia indicated cesarean section. However no distinction was made in this study between nulliparous and multiparous parturients. Since these comprise different groups with distinct labor curves, the question remains whether one should consider parity when deciding to perform early vs late amniotomy following balloon expulsion.

Both Amniotomy and Oxytocine infusion are part of the routine protocol and necessary procedures for induction of labor. Adverse outcome of amniotomy includes fetal heart rate changes, cord prolapse and intrapartum fever when labor is prolonged. Adverse outcome of oxytocine include hypertonus and fetal heart rate changes requiring cessation of oxytocine infusion (as in routine protocol) and intrapartum fever if labor is prolonged (not due to oxytocine infusion per se). Most of the patients admitted for induction of labor will need both amniotomy and oxytocine, however the role of the order of these two procedures is unclear ,as well as whether the order of these procedures affect the rate of adverse outcome.

The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age 37-42 weeks
  • Singleton pregnancy
  • Vertex presentation
  • Medical indication for induction of labor
  • Need for cervical ripening (Bishop score <=6)
  • Consent to participate in the study
  • Women age at or >18 years

排除标准

  • Multiple pregnancies
  • Preterm pregnancy
  • Previous cesarean section
  • Uterine malformation
  • Withdrawal of consent.

结局指标

主要结局

Delivery within 24 hours

时间窗: Up to 96 Hours

The proportion of women that delivered within 24 hours of induction

Time to delivery

时间窗: Up to 96 Hours

The time from induction defined as the primary intervention following balloon expulsion to delivery.

次要结局

  • Operative delivery(Up to 96 Hours)
  • Intrapartum fever(Up to 96 Hours)
  • Cesarean delivery(Up to 96 Hours)
  • Post partum hemorrhage(Up to 7 days)
  • Neonatal outcomes- Apgar(10 minutes)
  • Postpartum fever during the postpartum hospital stay(Up to 7 days)
  • Neonatal outcomes- infection(Up to 30 days)
  • Neonatal outcomes - PH umbilical(10 minutes)
  • Neonatal outcomes- NICU admission(Up to 30 days)

研究者

发起方
Assuta Ashdod Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eran Brazilay, MD PhD

Senior physician, OBGYN department

Assuta Ashdod Hospital

研究点 (1)

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