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

Máxima MC0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•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

•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)

发起方

Máxima MC