Last updated: December 8, 2023
Sponsor: Maxima Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Labor/delivery
Treatment
eCTG monitoring with the NFMS
Clinical Study ID
NCT06135961
NL82822.015.22
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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
Exclusion Criteria:
- 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 abdomenprecluding preparation of the abdomen with abrasive paper)
- Women connected to an external or implanted electrical stimulator, such asTranscutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbanceof 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 oflabour. eCTG monitoring is impossible in bath because the Bluetooth signal isdisturbed. 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 fordelivery 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. septicshock).
Study Design
Total Participants: 3471
Treatment Group(s): 1
Primary Treatment: eCTG monitoring with the NFMS
Phase:
Study Start date:
November 20, 2023
Estimated Completion Date:
February 15, 2026
Connect with a study center
Maxima MC
Veldhoven, Noord-Brabant 5504 DB
NetherlandsActive - Recruiting
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