Evaluation of Continuous Maternal Feedback to Shorten Second Stage Labor
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Length of second stage labor in patients using the PushCoach device compared to patients blinded to the PushCoach device output
研究概览
简要总结
This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.
详细描述
The length of the second stage (pushing stage) of labor is highly correlated with the incidence of adverse outcomes for mother and neonate. More than 80% of laboring women in the US have epidurals for labor pain management. The length of second stage labor is increased in women receiving regional anesthesia for pain management during labor and delivery compared to women without anesthesia. This increased length of labor is largely due to lack of maternal sensation resulting in decreased physiologic feedback on the efficacy of maternal expulsive (pushing) efforts. Continuous maternal feedback regarding fetal decent during labor may result in more effective maternal expulsive efforts reducing the length of second stage and improving maternal and neonatal outcomes. This study will assess the ability for continuous electronic feedback to reduce the length of second stage labor and improve maternal and fetal outcomes.
The study device consists of a modification of the standard fetal scalp electrode and a separate apparatus designed to detect movement of the fetal head by detecting movement of the FSE. As the patient pushes, the amount of fetal movement will be measured and recorded. The movement will be recorded by a laptop computer which will provide optical and auditory feedback to the patient about descent of the fetal head with maternal expulsive efforts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Laboring nulliparous women who are > 36 0/7 weeks estimated gestational age undergoing epidural or combined spinal epidural (CSE) placement for labor pain management.
排除标准
- •Women with multiple gestations.
- •Women with contraindications to pushing during second stage labor.
- •Women with contraindications to Fetal Spiral Electrode (FSE) placement including women with a face or compound presentation, known HIV, Hepatitis B or Active Herpes.
- •Women who do not plan to initiate pushing immediately (those who plan to "rest and descend" prior to initiation of pushing).
研究组 & 干预措施
Patients receiving PushCoach feedback
Patients will receive continuous maternal feedback from the PushCoach device, which includes both audio and visual feedback of fetal head movement during the second stage of labor
干预措施: Continuous Maternal Feedback (Device)
Patients blinded to PushCoach feedback
Patients will not receive continuous maternal feedback from the PushCoach device (it will be in place and collect data), but will receive normal feedback from the clinician during the second stage of labor.
干预措施: Continuous Maternal Feedback (Device)
结局指标
主要结局
Length of second stage labor in patients using the PushCoach device compared to patients blinded to the PushCoach device output
时间窗: Second stage of labor begins once the patient's cervix is completely dilated and ends once the baby is delivered. This time will be compared between patients.
The primary objective of this study is to measure the ability of immediate, quantitatively precise, visual, and auditory and haptic maternal feedback on fetal descent to reduce the overall length of second stage labor compared to women receiving standard verbal and manual feedback during second stage labor and reduce the incidence of pushing for longer than 60 minutes.
次要结局
未报告次要终点