Intrapartum non-invasive electrophysiological monitoring: F2-study.

Rationale: Since there is much debate about the poor specificity of the cardiotocogram (CTG), additional techniques for fetal surveillance during labour have been developed. The disadvantage of these techniques, such as fetal blood sampling (FBS) and ST-analysis of the fetal electrocardiogram (ECG; STAN), is that they are invasive and can only be performed when membranes have ruptured. Non-invasive fetal ECG (NI-fECG) monitoring can overcome these disadvantages, by providing both an accurate fetal heart rate (FHR) and information on the fetal ECG morphology, both in a non-invasive way.

Objective: This study aims to validate NI-fECG monitoring as an accurate and reliable monitoring technique for fetal surveillance during labour. The aim of this validation is to work towards clinical implementation of NI-fECG monitoring.

Study design: This study is designed as a cross-sectional observational study, with a prospective nature.

Study population: Pregnant women who are in labour, carrying a healthy, singleton fetus in cephalic presentation, with a gestational age between 37 and 42 weeks. We aim to include 100 patients.

Intervention (if applicable): In addition to standard intrapartum monitoring by fetal scalp electrode (FSE) with tocodynamometer, eligible patients will also receive a transabdominal, non-invasive fECG patch, from the moment of start of fetal monitoring until the end of delivery. Also, at several moments during labour fetal position will be checked by short ultrasound measurements.

Main study parameters/endpoints: The main endpoint of this study is to assess the accuracy and reliability of the NI-fECG monitorings for FHR and MHR. This will be compared to the accuracy of the gold standard FSE monitoring and pulse oximetry, respectively. Electrohysterogram (EHG) signals retrieved by the non-invasive fECG patch will be analysed and compared with the tocodynamometer/intrauterine pressure catheter (IUPC). Furthermore, fECG waveform details will be analysed and relevant information will be correlated to several clinical maternal and fetal parameters..

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in this validation study will cause no risk for the patient. There is a very small chance that participating patients experience skin irritation or a minor allergic (local) reaction to the skin electrodes from the NI-fECG patch.

Since there is much debate about the poor specificity of the cardiotocogram (CTG), additional techniques for fetal
surveillance during labour have been developed. The disadvantage of these techniques, such as fetal blood
sampling (FBS) and ST-analysis of the fetal electrocardiogram (ECG; STAN), is that they are invasive and can
only be performed when membranes have ruptured. Non-invasive fetal ECG (NI-fECG) monitoring can overcome
these disadvantages, by providing both an accurate fetal heart rate (FHR) and information on the fetal ECG
morphology, both in a non-invasive way.

During labour.

In addition to standard intrapartum monitoring by fetal scalp electrode (FSE) with tocodynamometer, eligible patients will also receive a transabdominal, non-invasive fECG patch, from the moment of start of fetal monitoring until the end of delivery. Also, at several moments during labour fetal position will be checked by short ultrasound measurements.