COntinuous fetal heart rate Monitoring using non-invasive Fetal electrocardiographY 2 (COMFY 2)

We have developed a new device to detect the fetal heart beat, a fetal electrocardiogram (ECG) device. We will assess the accuracy of our fetal ECG in this study. This will involve recruiting 90 women from three gestational age ranges (24-30, 30-36 and more than 36 weeks gestation) for the duration of their in-clinic cardiotocography (CTG) monitoring to ensure we are accurately detecting the fetal heart rate. We will also recruit 90 women during labour to determine the device’s ability to detect the fetal heart and uterine contractions during labour. This will allow us to ensure the fetal ECG device is comfortable and we will be able to optimize its output. Next we will recruit 90 women from across the same 3 gestational ages and assess the fetal ECG over a 24 hour period. Finally, we will perform a cross over study where we will recruit 60 women at term and assess the output from our fetal ECG device over 24 hours then assess the output of the Monica AN24 device (an existing fetal ECG device available for research) to see whether our device more accurately detects the fetal ECG. Our novel device differs compared to the Monica device as our device has one sheet of electrodes and we are using updated algorithms to extract the fetal heart rate. The Monica device has multiple electrodes that are positioned all over the mother's abdomen and uses different algorithms to extract the fetal heartbeat. No additional training is required to position our device or the Monica device. The sensor is placed on the abdomen and the monitor is switched on. We will also replicate these studies in women with twins. This study will occur over 5 years.