NL-OMON55415已完成不适用
Implementation of intrapartum non-invasive electrophysiological monitoring: a pilot study. - Intrapartum electrophysiological monitoring: pilot study.
Maxima Medisch Centrum0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Pregnant women with a gestational age between 36 and 42 weeks.
- •- Admission to the labor ward because of labor and indication for fetal
- •monitoring during labor.
- •- Singleton fetus in cephalic presentation.
- •- Oral and written informed consent is obtained.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Women under the age of 18 years.
- •- Language barrier (other language than Dutch or English)
- •- Women with a multiple pregnancy.
- •- Fetal cardiac arrhythmias (detected and confirmed during pregnancy by
- •ultrasound).
- •- Contraindications to abdominal patch placement (dermatologic diseases of the
- •abdomen precluding preparation of the abdomen with abrasive paper).
- •- Women in labor taking a bath (because the Bluetooth signal is disturbed and
- •monitoring is impossible). It is possible to take a shower.
- •- Women connected to external or implanted electrical stimulators, such as
- •Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of
- •disturbance of the electrophysiological signal we want to measure, not because
- •of danger for mother or child).
- •- Contraindications for monitoring using a FSE (coagulation disorders and
- •maternal infections like HIV or hepatitis)
研究者
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