COntinuous fetal heart rate Monitoring using non-invasive Fetal electrocardiographY 3 (COMFY 3)

The Kali Monitoring System is a new device that is able to detect fetal heart rate, maternal heart rate and uterine activity using non-invasive electrocardiogram (ECG) technology. In this study we seek to evaluate the reliability, safety and user experience of the Kali Monitoring System for monitoring fetal heart rate, maternal heart rate and uterine activity. We plan to recruit a total of 100 women. Participants will also receive a questionnaire about fetal monitoring prior to having the Kali Monitoring System applied and their experience with participation at the conclusion. Antenatal participants will also be asked to complete The State Trait Anxiety Inventory and a System Usability Scale. Midwives will take notes on usability issues encountered during use. Once the informed consent is signed, participants are asked to sit on a reclined chair or lie on a hospital bed for application of the Kali Monitoring System and CTG (cardiotocography - the current clinical standard-of-care). The researcher prepares the patient's skin by cleaning it and by using skin preparation gel. The researcher proceeds with setting up the Kali Monitoring System including connection to the Kali Cloud and Kali Application on a smart phone, in parallel with setting up the standard of care CTG. With this setup, data is collected with both devices, while the Kali Monitoring System performs an electrode connection and signal quality check (screening test). This step may take up to 5 minutes. If the electrode connection check fails or the CTG does not capture the maternal heart rate or fetal heart rate signals, the measurement setup is adjusted as needed (up to three attempts are allowed). A participant is considered included for data analysis when the electrode connection and signal quality screening test gives a successful result (performed automatically by the Kali Monitoring System) and at least 30 minutes of data is collected from both the Kali Monitoring System and standard-of-care CTG. Recordings will be taken from both the Kali Monitoring System and CTG for at least 30mins or the duration of the CTG in pregnancy and/or labour and birth. For participants recruited in labour application and insertion of a fetal scalp electrode and intrauterine pressure catheter will be required (if not contraindicated). If a potential labour participant does not consent or has contraindications to the fetal scalp electrode and/or intrauterine pressure catheter they will be excluded from participation in the trial. A participant will only be recruited once over the duration of the study.