Implementation of intrapartum non-invasive electrophysiological monitoring

Recruiting

• Conditions: Maternal and perinatal outcomes; 10010273

• Registration Number: NL-OMON56299
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 5571

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
abdomen
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
of the
electrophysiological signal)
- Treatment plan (with intervention plan) already made before inclusion is
completed
- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of operative interventions during labour; caesarean section or<br /><br>instrumental vaginal deliveries. </p><br>