Women with high-risk pregnancies (eg, pre-eclampsia, imminent preterm birth) are often hospitalised due to the need for foetal and maternal monitoring. They are monitored for 30–45 min up to three times a day with conventional cardiotocography (CTG). In the meantime, they reside at the hospital, but the foetal status is not monitored. Continuous foetal monitoring is currently not recommended using CTG, due to the potential temperature rise from consistent exposure to ultrasound waves. For safe 24/7 monitoring, newly developed devices using non-invasive electrophysiological cardiotocography (eCTG) instead of conventional CTG offer a promising alternative. Previous research into eCTG has shown favourable results in monitoring foetal heart rate throughout both pregnancy and labour. This study aims to investigate the effect of implementing continuous antepartum eCTG monitoring in hospitalised high-risk pregnancies on perinatal and maternal outcome.

In this single centre prospective cohort intervention random sampling study, eligible women will be included on the Obstetric High Care of Máxima MC Veldhoven, the Netherlands. In total, 511 pregnant women with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalisation will be recruited. Eligible women will be prospectively included in the cohort receiving standard treatment: intermittent CTG monitoring. From these women, a random sample of the prospective cohort will be offered a new monitoring method: 24/7 eCTG monitoring. For the eCTG monitoring, a wireless abdominal electrode patch, the Nemo Foetal Monitoring System will be used. Additional data from a historical cohort (2014–2019) of 1400 women receiving standard treatment will be included. Perinatal and maternal outcome, along with satisfaction levels of both patient and caregivers, will be compared between groups.

The study is registered on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22) via https://www.toetsingonline.nl/to/ccmo_monitor.nsf/conceptabr?OpenForm and approved by the Medical Ethics Committee of Máxima MC (W22.070) on 7 November 2023. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

NCT06151613.

Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.

This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.

This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

NCT06135961.