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临床试验/NCT00380978
NCT00380978已完成不适用

Early Compared With Late Neuraxial Analgesia in Nulliparous Labor Induction

Northwestern University2 个研究点 分布在 1 个国家目标入组 1,026 人开始时间: 2001年10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
1,026
试验地点
2
主要终点
Delivered by Cesarean Section

研究概览

简要总结

The purpose of this study in nulliparous women undergoing induction of labor is to determine whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in labor (< 4 cm cervical dilation)affects the cesarean delivery rate.

详细描述

Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) injection). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, vomiting, and neonatal respiratory depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural versus IV/IM narcotic labor analgesia (not specifically in early labor)suggest that initiation of early neuraxial analgesia may be associated with higher Cesarean delivery rates. It has been hypothesized that epidural/spinal local anesthetics may induce pelvic musculature relaxation leading to failure of fetal descent and rotation. However, early pain may be a marker for other factors that increase the risk of Cesarean delivery, e.g., large or malpositioned baby, or dysfunctional labor. Whether or not early neuraxial analgesia (particularly if narcotic based, which would not cause pelvic muscle paralysis) compared to IV/IM narcotics, adversely affects the outcome of labor has not been studied in a randomized, prospective fashion. The purpose of this study is to compare Cesarean and forcep delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial versus IV/IM analgesia for early labor (cervical dilation < 4 cm).

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • induction of labor
  • nulliparity
  • >36 weeks gestation
  • singleton
  • vertex position
  • cervical dilation < 4 cm at first request for analgesia
  • desires neuraxial analgesia

排除标准

  • spontaneously laboring
  • multiparity
  • nonvertex presentation
  • at or >4cm at analgesia request
  • chronic opioid therapy
  • acute opioid therapy within 4 hours of analgesia request
  • allergy to study drugs (hydromorphone, fentanyl, bupivacaine, lidocaine)

结局指标

主要结局

Delivered by Cesarean Section

时间窗: Time form initiation of labor analgesia to delivery (up to 24 hours)

The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.

次要结局

  • Instrumented Vaginal Delivery(At time of decision for delivery)
  • Duration of Labor(Initiation of induction of labor to time of delivery)
  • Indication for Cesarean Delivery(At time of decision for delivery)
  • Analgesia Efficacy(At first and second analgesia requests)
  • Nausea(At second analgesia request)
  • Neonatal Outcome (APGAR Score < 7 at 5 Minutes)(APGAR score at 5 minutes)
  • Vomiting(Vomiting at second analgesia request)

研究者

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

Cynthia Wong

Professor of Anesthesiology

Northwestern University

研究点 (2)

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