Non-invasive monitoring of fetal health during labor
Implementation of Intrapartum Non-invasive Electrophysiological Monitoring
This study is testing a new way to monitor a baby's health during labor to see if it works better than the usual method, especially for women with higher body weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3471 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maxima Medical Center Academic / other |
| Locations | 1 site (Veldhoven, Noord-Brabant) |
| Trial ID | NCT06135961 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new non-invasive electrophysiological monitoring method, known as eCTG, compared to traditional cardiotocography (CTG) for monitoring fetal health during labor. The eCTG method measures fetal heart rate and uterine activity more accurately and reliably, particularly in cases where maternal body mass index may affect results. The study will assess outcomes related to delivery mode, maternal and perinatal health, costs, and perspectives from both patients and healthcare professionals. Participants will include pregnant women with a singleton fetus in cephalic position who require fetal monitoring during labor.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older, with a singleton fetus in cephalic position, and a gestational age between 37 and 42 weeks.
Not a fit: Patients with multiple pregnancies, fetal or maternal cardiac arrhythmias, or those who cannot comply with the study's monitoring requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved fetal monitoring and better neonatal outcomes during labor.
How similar studies have performed: While traditional CTG has been widely used, the eCTG approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Veldhoven, Noord-Brabant
- Maxima MC — Veldhoven, Noord-Brabant, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.