Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT06135961
Eligibility Criteria:
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 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 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).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06135961
Study Brief:
Protocol Section:
NCT06135961