跳至主要内容
临床试验/NL-OMON56299
NL-OMON56299招募中不适用

Implementation of intrapartum non-invasive electrophysiological monitoring - NIEM-II study

Maxima Medisch Centrum0 个研究点目标入组 5,571 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,571

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria:
  • - Minimal age of 18 years old
  • - Pregnant women with a gestational age between 37+0 and 42+0 weeks and days
  • - Indication for fetal monitoring during labour
  • - Singleton fetus in cephalic position
  • - 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:
  • - Insufficient knowledge of Dutch or English language
  • - Women with a multiple pregnancy
  • - Fetal and/or maternal cardiac arrhythmias
  • - Contraindications to abdominal patch placement (dermatologic diseases of the
  • precluding preparation of the abdomen with abrasive paper)
  • - Women connected to an external or implanted electrical stimulator, such as
  • Transcutaneous
  • Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance
  • electrophysiological signal)
  • - Treatment plan (with intervention plan) already made before inclusion is
  • - Women who were included in the study, but when circumstances before
  • labour call for delivery
  • of the baby by unplanned caesarean section
  • - There is insufficient time for proper counselling
  • - Women admitted with a clinical diagnosis of sepsis with hypotension
  • (i.e. septic shock)

研究者

发起方
Maxima Medisch Centrum

相似试验