A Randomized Clinical Trial of Fetal Pulse Oximetry
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
- 是
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
