跳至主要内容
临床试验/NL-OMON25234
NL-OMON25234
已完成
不适用

Implementation of intrapartum non-invasive electrophysiological monitoring: a pilot study

Máxima MC0 个研究点目标入组 50 人待定

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
未指定
发起方
Máxima MC
入组人数
50
状态
已完成
最后更新
2年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Observational non invasive

研究者

发起方
Máxima MC

入排标准

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 (Patient information folder is available in English and Dutch)
  • \- Women with a multiple pregnancy
  • \- Fetal cardiac arrhythmias (detected and confirmed during pregnancy by ultrasound)
  • \- Contraindications to abdominal patch placement (dermatological disease 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)

结局指标

主要结局

未指定

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