跳至主要内容
临床试验/NCT01605474
NCT01605474Unknown不适用

Safety, Efficacy, and Patient Satisfaction of Cervical Ripening With Transcervical Use of the Foley Catheter in an Outpatient Setting

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
800
试验地点
2
主要终点
Cesarean section rate

研究概览

简要总结

This study examines whether outpatient pre-induction cervical ripening improves patient satisfaction and is safe and effective.

详细描述

Objective:

To compare inpatient versus outpatient preinduction cervical ripening in order to evaluate differences between each setting with respect to patient safety, satisfaction and cesarean rate.

Background:

Many women who require induction of labor present with an unripe cervix. This has been associated with a longer duration of labor as well as higher rates of failed induction resulting in cesarean delivery. These patients are also at higher risk for postpartum hemorrhage, blood transfusion, and cesarean hysterectomy. Preinduction cervical ripening is thought to improve the likelihood of a successful induction in women with an unripe cervix. Prolonged inductions of labor do not only lead to patient dissatisfaction but also use valuable resources such as available labor and delivery bed and nursing staff. This in turn overburdens labor and delivery resources which are already taxed. These issues contribute to increasing costs as well as decreasing patient satisfaction.

Prior studies have shown that moving preinduction cervical ripening from an inpatient setting to an outpatient setting can decrease costs significantly. It is also thought that 50% of all patients requiring induction of labor may be eligible for outpatient cervical ripening. Many of these studies have looked at PGE two preparations which are no longer commonly used. However, a study by Scisione et al. from November 2001 looked at the use of Trent cervical Foley catheter for this purpose. They had previously shown that a mechanical method, the Foley catheter, had significant advantages over preparations such as prepidil. Scisione et al. had also previously shown that in a randomized trial comparing misoprostol and Foley catheter for preinduction cervical ripening both were found to be equally effective. However, in the group who received the misoprostol, there was an increased risk of meconium passage in uterine contractile abnormalities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • term pregnancy
  • singleton gestation
  • cephalic presentation
  • scheduled for an induction of labor (acceptable conditions include gestational diabetes, chronic hypertension)
  • Exclusion criteria include the following:
  • placenta previa and/or accreta
  • low lying placenta
  • undiagnosed vaginal bleeding
  • preeclampsia
  • fetal anomaly
  • intrauterine growth restriction
  • RH isoimmunization
  • fetal demise
  • rupture of membranes
  • maternal heart disease
  • known latex allergy
  • active genital herpes infection
  • previous uterine surgery
  • limited access to a telephone
  • excessive distance from the hospital, and/or
  • unreliable transportation

排除标准

  • 未提供

结局指标

主要结局

Cesarean section rate

时间窗: 2 years

Cesarean delivery rate between groups

次要结局

  • NICU admissions(2 years)
  • Patient satisfaction (Pain /discomfort)(2 year)
  • Apgar scores(2 years)

研究者

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

Gregory W. Lau, MD

Fellow, Maternal Fetal Medicine

Cedars-Sinai Medical Center

研究点 (2)

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