Validation of Sensors for Long-term Non-Invasive Fetal Monitoring

Launched by UNIVERSITY OF MANCHESTER · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new sensor designed to monitor the heartbeats and movements of babies during late pregnancy. The goal is to see if this sensor can provide accurate information about the health of the baby, particularly to identify if the baby is not getting enough oxygen. The sensor is non-invasive, meaning it can be placed on the mother's skin without any sticky attachments, which may allow for longer monitoring times. The trial involves two parts: the first will fine-tune the sensor with up to 24 women to ensure it works well without interference from movement or other devices, and the second will include up to 45 women to compare the sensor’s readings with current methods.

To participate, women must be at least 16 years old and have a healthy, single pregnancy after 28 weeks, with the baby’s weight being between the 10th and 90th percentiles. Unfortunately, those with certain fetal conditions, multiple pregnancies, or who cannot understand English will not be eligible. Participants can expect to wear the sensor for monitoring during their pregnancy, and their involvement will help in developing a new device for better fetal monitoring in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Participants will be included if they have a non-anomalous singleton pregnancy after 28 weeks' gestation with an estimated fetal weight \>10th centile \< 90th centile. Participants will be 16 years or over in order that they can give independent consent.
• Exclusion Criteria:
• • Participants will be excluded if there are fetal anomalies (as defined by the NHS Fetal Anomaly Screening Programme - https://www.gov.uk/guidance/fetal-anomaly-screening-programme-overview), it is a multiple pregnancy, there is evidence of Fetal Growth Restriction (Estimated Fetal Weight \<10th centile) or if participants cannot speak or do not understand fluent English. Participants will not be able to participate if they are unable to give informed consent. Participants \<16 years of age will be excluded from this study.