New sensor for monitoring fetal health during late pregnancy
Measurement and Validation of Fetal Heart and Fetal Movement Signals Detected Via Non-adhesive Sensors
This study is testing a new non-adhesive sensor to see if it can accurately monitor the heart rates of pregnant women and their babies during late pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Manchester Academic / other |
| Locations | 1 site (Manchester) |
| Trial ID | NCT06952777 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a non-adhesive sensor designed to monitor the heart rates of mothers and their babies during late pregnancy. A multidisciplinary team will test the sensor's ability to consistently detect fetal heart signals while minimizing interference from external electrical noise. Up to 24 pregnant women will participate, wearing the sensor in three different late pregnancy time frames to assess its reliability and accuracy compared to current monitoring techniques. The study will also involve basic assessments of the participants' health and the baby's well-being before sensor application.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 16 years old with a singleton pregnancy between 28 and 40 weeks gestation and an estimated fetal weight between the 10th and 90th centiles.
Not a fit: Patients with fetal anomalies, multiple pregnancies, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this sensor could provide a reliable method for long-term monitoring of fetal health, potentially identifying distress earlier and improving outcomes.
How similar studies have performed: While similar approaches to fetal monitoring exist, this specific sensor technology is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manchester
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alexander Heazell, PhD — University of Manchester
- Study coordinator: Alexander Heazell, PhD
- Email: alexander.heazell@manchester.ac.uk
- Phone: +441612766484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.