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

NCT06952777 | Recruiting

• 1 other identifier: 107586
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

A multidisciplinary team of a doctor and engineers have developed a new sensor that will be able to detect mothers' and babies' heartbeat and babies movements in late pregnancy. This sensor can be placed in contact with the mothers' skin over the pregnant uterus without having to be stuck down. We anticipate that this sensor would allow us to monitor babies for longer periods of time which might help us to better identify babies who are being deprived of oxygen during pregnancy. We need to test these sensors on women in late pregnancy for two reasons. Firstly, we need to ensure they reliably measure mother and babies heart rates without interference from movement or other electrical equipment. Secondly we need to ensure that the information they provide is accurate (compared to current measurement techniques). We will carry out two related studies. The first will include up to 24 women to develop the sensors to ensure that they can obtain consistent signals from mothers' and babies' heartbeats without interference from movement and other electronic devices. We will adjust the electronics in the sensors to ensure they give the best signal. The second will include up to 45 women to see whether the information detected by the sensors is comparable to existing technologies. This information will help us to see whether these sensors can be organised into a new device for fetal monitoring which can then be tested.

Conditions

Fetal Distress With Antenatal Problem; Fetal Growth Retardation

Keywords

Fetal monitoring; Fetal heart rate monitoring

Outcome Measures

Primary Outcomes (1)

• Recording quality of non-adherent sensors

  Proportion of recording time that non-adherent sensors record fetal heart rate

  0-60 minutes recording during

Secondary Outcomes (2)

• Maternal comfort

  Immediately after the recording period

• Maternal anxiety

  Immediately prior to or after the recording period

Study Arms (1)

Women using sensors

EXPERIMENTAL

Participants will be asked to complete a short baseline questionnaire before commencing the monitoring process. Participants will be asked to lie on an examination couch for up to 60 minutes at 45 degrees while the electronic sensor(s) are gently held in contact with the maternal abdomen by an elastic belt. In addition to the new sensors the fetal and maternal heart rate will be recorded using the MONICA AN24 device and fetal movements will be recorded with ultrasound (for 20 minutes of the 60). If participants are uncomfortable they will be able to sit or stand to relieve their discomfort. Basic information including body mass index, stage of pregnancy and estimated fetal weight will be recorded on a proforma. In addition, participants will be asked to complete a questionnaire about anxiety and wearing the device after the monitoring process.

Other: Non-adhesive capacitively-coupled sensors

Interventions

Non-adhesive capacitively-coupled sensors OTHER

Non-adhesive capacitively-coupled sensors which can detect signals of the magnitude of the fetal heart rate and information about fetal movements.

Women using sensors

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Heazell, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Heazell, PhD

CONTACT

+441612766484; alexander.heazell@manchester.ac.uk

Emma Tomlinson, RM

CONTACT

+441617016965; emma.tomlinson@mft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking of participant or investigator
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm study comparing sensor output with existing methods of detecting fetal heart rate.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)