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临床试验/NCT00098709
NCT00098709终止3 期

A Randomized Clinical Trial of Fetal Pulse Oximetry

The George Washington University Biostatistics Center25 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2002年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
终止
发起方
入组人数
10,000
试验地点
25
主要终点
cesarean delivery (any indication)

研究概览

简要总结

The purpose of this study is to determine if the information provided to the physician by a fetal pulse oximeter during labor will reduce the chances of a cesarean delivery.

详细描述

Information on fetal well-being during labor is of great importance to the managing physician. The current use of the fetal heart rate monitor provides some information on fetal condition, and is the primary tool used to determine if immediate operative delivery is required. The fetal pulse oximeter can provide additional information regarding fetal oxygen saturation.

Intervention: A fetal oxygen saturation sensor is placed in the uterus, between the fetal cheek or forehead and the uterine wall. In half of the patients, the managing physician will have access to fetal oxygen saturation and fetal heart rate monitoring. In the other half of the patients, labor will be monitored by fetal heart rate alone.

Study hypothesis: The additional information provided by the use of the fetal pulse oximeter will reduce the chances of a cesarean delivery. The primary outcome is cesarean section for any indication and secondary outcomes are cesarean delivery for non-reassuring fetal heart rate or dystocia, and neonatal morbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Nulliparous
  • Singleton, cephalic pregnancy
  • Gestational age at least 36 weeks, 0 days
  • Cervical dilatation >= 2 cm
  • Station -2 or below (5ths scale)
  • Ruptured membranes
  • Internal monitoring devices placed

排除标准

  • Need for immediate delivery
  • Planned cesarean delivery
  • Cervical dilatation > 6 cm
  • Known fetal anomaly or demise
  • Multifetal gestation
  • Maternal fever
  • Placenta previa
  • Previous uterine surgery
  • Active HSV infection
  • Known HIV or hepatitis infection
  • Diabetes requiring insulin
  • Heart disease requiring medication
  • Known chronic renal disease
  • Enrollment in another labor study

结局指标

主要结局

cesarean delivery (any indication)

次要结局

  • cesarean delivery for non-reassuring fetal heart rate
  • cesarean delivery for dystocia
  • neonatal morbidity

研究者

发起方
The George Washington University Biostatistics Center
申办方类型
Other
责任方
Sponsor

研究点 (25)

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