New sensor for monitoring fetal health during late pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.