Status:
RECRUITING
Intrapartum Non-invasive Electrophysiological Monitoring
Lead Sponsor:
Maxima Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Fetal Monitoring
Non-invasive
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Conventional cardiotocography (CTG) has been used extensively for more than 50 years to monitor the fetal condition during labour, but since the rate of operative deliveries keeps rising, its ability ...
Eligibility Criteria
Inclusion
- 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
- 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)
- Women who take a bath for multiple times during delivery and/or who take a bath for \> 1 hour during the first stage of labour and/or who take a bath in the second stage of labour. eCTG monitoring is impossible in bath because the Bluetooth signal is disturbed. In bath, monitoring will be performed by conventional CTG monitoring. However, it is possible to take a shower with eCTG monitoring
- 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).
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2026
Estimated Enrollment :
3471 Patients enrolled
Trial Details
Trial ID
NCT06135961
Start Date
November 20 2023
End Date
February 15 2026
Last Update
December 15 2023
Active Locations (1)
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1
Maxima MC
Veldhoven, North Brabant, Netherlands, 5504 DB