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Clinical Trials/NL-OMON56299
NL-OMON56299
Recruiting
Not Applicable

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

Maxima Medisch Centrum0 sites5,571 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal and perinatal outcomes
Sponsor
Maxima Medisch Centrum
Enrollment
5571
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Maxima Medisch Centrum

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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