Intrapartum Non-invasive Electrophysiological Monitoring

NCT ID: NCT06135961

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3471 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2026-02-15

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 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.

Conditions

Fetal Monitoring; Non-invasive; Cardiotocography; Electrocardiography; Caesarean Section

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

eCTG monitoring

eCTG monitoring with the Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands).

The NFMS consists of a wireless and beltless electrode patch on the maternal abdomen. It monitors fetal heart rate by fetal electrocardiography, maternal heart rate by maternal electrocardiography and the electrical activity of the uterine muscle by electrohysterography.

The advantage of the NFMS is that it is a safe method that can be used in all situations that are contraindicated for invasive monitoring. Furthermore, it can be used when the membranes are not ruptured and the patch does not have to be repetitively repositioned during labor. Because the NFMS is wireless, it gives women more freedom of movement during labor.

Group Type: ACTIVE_COMPARATOR

eCTG monitoring with the NFMS

Intervention Type: DEVICE

Device: Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands)

Conventional CTG monitoring

Philips Avalon FM 30 (Philips Healthcare, Eindhoven, the Netherlands).

The fetal heart rate is measured non-invasively by doppler ultrasound or invasively by fetal scalp electrode. The uterine activity and maternal heart rate is measured by tocodynamometry.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eCTG monitoring with the NFMS

Device: Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands)

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Maxima Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Phebe Berben

Medical doctor, PhD Candidate, Coordinating Investigator NIEM-II study

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maxima MC

Veldhoven, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Phebe Berben, Medical Doctor, PhD Candidate

Role: primary

References

Berben PBQ, de Klerk ND, van der Ven M, Fransen AF, Niemarkt HJ, van den Heuvel ER, van der Hout-van der Jagt MB, Oei SG, van Laar JOEH. Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study). BMJ Open. 2025 Jul 22;15(7):e102901. doi: 10.1136/bmjopen-2025-102901.

Reference Type: DERIVED

PMID: 40701589 (View on PubMed)

Other Identifiers

NL82822.015.22

Identifier Type: -

Identifier Source: org_study_id