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临床试验/NCT00565383
NCT00565383已完成不适用

The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position

Northwestern University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2002年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Does combined spinal-epidural analgesia improve the success rate of external cephalic version?

研究概览

简要总结

We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of Cesarean delivery for malpresentation.

详细描述

At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. Cesarean delivery, the safer option for the baby, however, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. External cephalic version is a procedure commonly used to attempt to manually rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications.

Obstetricians perform versions after 36 weeks gestational age with a reportable success rate of 30-80%. The most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. Pain relief is most commonly provided in the form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia.

Although the use of neuraxial analgesia and anesthesia techniques improve maternal pain and satisfaction, there is conflicting evidence if they improve the success rate of version procedures. The American College of Obstetricians and Gynecologists (ACOG) has stated, "Currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ECV (external cephalic version) attempts."

We propose to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural analgesia on the success rate of external version for breech fetal position and the subsequent incidence of vaginal vs. Cesarean delivery as a secondary outcome.

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

入选标准

  • 18-55 years of age
  • Breech Presentation
  • Greater than 36 Weeks gestation
  • Version Procedure

排除标准

  • Under 18 or over 55 years of age

结局指标

主要结局

Does combined spinal-epidural analgesia improve the success rate of external cephalic version?

时间窗: Time between analgesia intervention for the version procedure and delivery

次要结局

  • Mode of delivery(At delivery)
  • Maternal satisfaction(Between analgesic intervention and the completion of the version procedure)
  • Maternal Pain(Between analgesic intervention and termination of the version procedure)

研究者

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

John Sullivan

John T. Sullivan M.D.

Northwestern University

研究点 (2)

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