WOMB: Wearable device to Observe Movements of your Baby study
Research type
Research Study
Full title
WOMB: Wearable device to Observe Movements of your Baby (WOMB) study. An observational study to investigate the effectiveness and acceptability of a wearable smart garment to independently detect foetal movements in pregnant women
IRAS ID
288119
Contact name
Suzanna Dunkerton
Contact email
Sponsor organisation
KYMIRA Ltd
Clinicaltrials.gov Identifier
2021-002341-15, EudraCT
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Fetal movements are reassuring for fetal health. It can be difficult for some woman to appreciate fetal movements and this can lead to unnecessary medical intervention. We propose to test a thin, flexible textile-like sensor (which is conformable, breathable, and washable) embedded within a wearable garment, KYMIRA will create a solution that is easier and more comfortable for longer term monitoring. Moreover, the wearable will be fully washable, enabling better hygiene and potentially allow 24 hour monitoring.
We aim to correlate objectively measured fetal movements with those detected by the device via real-time imaging of the moving fetus using ultrasound. The study intervention will involve four ultrasound scans lasting 20 mins during which fetal movements will be recorded by the scan operator. The fabric device will also be worn on the mother’s abdomen and will also be recording movement. The mother will also have a button to press when she feels movements. The four scans will happen at 2 week intervals from 32 weeks of pregnancy.
Other studies have looked into various devices. Often these are bulky, non-washable and require hospital visits. Some use methods, such as picking up the acoustics of fetal movement (Lai J, 2018)). Our device works by using a piezoelectric fabric which essentially generates a tiny voltage when the material is bent or stretched. These studies have also looked at a 20-30min scan period and have shown this is sufficient time to notice movements (Melendez TD, 1992)).REC name
HSC REC A
REC reference
21/NI/0115
Date of REC Opinion
14 Jul 2021
REC opinion
Further Information Favourable Opinion