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 to improve neonatal outcomes is unsatisfactory. A transabdominal non-invasive and wireless alternative which overcomes the shortcomings of conventional methods is electrophysiological CTG (eCTG) monitoring. In eCTG the fetal heart rate (FHR) is measured by fetal electrocardiography (NI-fECG) and uterine activity (UA) by electrohysterography (EHG). Both NI-fECG and EHG have been proven more accurate and reliable than conventional non-invasive methods and are less affected by maternal body mass index (BMI).
This study aims to evaluate the mode of delivery, maternal and perinatal outcomes, costs and patient and healthcare professionals perspectives on eCTG monitoring versus the conventional CTG during labour at term with a singleton fetus in cephalic position.
The eCTG provides a more accurate assessment of the fetus and the UA, compared to the conventional CTG. This allows for optimization of the contraction pattern during high-risk deliveries. We hypothesize that this will reduce the number of operative interventions and improves perinatal outcome. There are three reasons why an improvement in the contraction pattern by the eCTG can influence our outcomes:
1. EHG can detect excessive UA more accurately. Increased UA is a major risk for fetal distress. In this case, stimulation with oxytocin should be reduced or stopped. More adequate interpretation of FHR, reduced tachysystole and reduced hypertonia is expected to result in fewer instrumented vaginal deliveries and a reduction of caesarean sections due to fetal distress.
2. EHG can demonstrate unorganized UA that needs to be corrected with a higher dose of oxytocin to enhance contraction frequency and efficiency. This can result in a less exhausted uterine muscle, shorter time to delivery, less vacuum deliveries and caesarean sections due to failure of progress. A shorter time to delivery will also result in a reduction of infections and blood loss.
3. Accurate registration of the relation between the contraction and decelerations of FHR, is expected to result in more reliable assessment of the fetal condition. This can result in fewer unnecessary operative deliveries and less unpredictable poor perinatal outcomes.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hypoten…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring the number of operative interventions like caesarean sections during labor — can you explain how adding non-invasive electrophysiological monitoring alongside standard cardiotocography might affect decisions about whether I need a C-section or other interventions during my labor?
2The recruitment status for this trial is listed as unknown, which means it's unclear whether it's still actively enrolling — do you know if this study is currently accepting participants, and would it even be an option for me to consider?
3Since this study involves placing additional monitoring electrodes on me during labor on top of the usual fetal monitoring, can you walk me through exactly what that would involve physically and whether it would change how I experience labor or limit my movement?
4How does the fetal heart rate information from this non-invasive electrophysiological approach compare to what's already captured by the standard cardiotocography I'd receive anyway, and would being in this trial give me any monitoring I wouldn't otherwise get?
5Given that this is labeled as a monitoring study rather than a treatment trial, is there any meaningful risk to me or my baby from participating, or would my care otherwise be the same as if I weren't enrolled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of operative interventions during labor