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.
Investigators
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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