Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

NCT07124325 | Recruiting

• 1 other identifier: 27-6-194
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this research proposal is to explore the feasibility and acceptability of home antenatal maternal-fetal monitoring technology within a high-risk pregnancy group. The investigators hypothesise that home monitoring is feasible and acceptable to both pregnant women and HCPs. 50 women from a single site will be recruited to use a home cardiotocography (CTG) device alongside routine antenatal care. Participants will use this device once a week, for an hour at a time, for up to 6 weeks or until delivery. The primary outcome is 20 minutes of continuous monitoring. Additional outcomes assess acceptability, adherence and safety.

Conditions

Pregnancy; High Risk; Telemonitoring; Telemedicine; Cardiotocography

Outcome Measures

Primary Outcomes (1)

• The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring.

  Completion of an at least 20 minutes of uninterrupted interpretable fetal heart recording which has computerised capability. This will be defined as a percentage derived from the number of monitoring episodes achieving the primary outcome divided by the total number of monitoring episodes.

  Through study completion, an average of 9 months

Secondary Outcomes (12)

• The number of participants completing the full schedule of home maternal-fetal monitoring episodes.

  Through study completion, an average of 9 months

• The number of women approached who agreed to participate within the study.

  Pre-intervention

• What are the emotions of participants using home maternal-fetal monitoring.

  Pre-intervention

• What are the emotions of participants using home maternal-fetal monitoring and is there an impact before and after a singular monitoring episode?

  Through study completion, an average of 9 months

• What are the emotions of participants using home maternal-fetal monitoring and was there any change from the beginning of the study.

  Immediately after the intervention

Study Arms (1)

Home antenatal CTG monitoring

EXPERIMENTAL

Participants will be asked to use the remote monitoring devices one a week for a 1 hour each time for up to 6 weeks or until delivery. Participants are eligible if they are aged 18 over over, 32+0 gestation onwards, singleton pregnancy, able to speak English and have at least one of 6 high-risk pregnancy conditions.

Device: Pregnabit Pro device and PregnaOne platform

Interventions

Pregnabit Pro device and PregnaOne platform DEVICE

Remote CTG device and online dashboard for remote pregnancy care

Home antenatal CTG monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18 years
• Gestational age 32+0 weeks onwards.
• Singleton pregnancy.
• Able to speak English
• Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 6 index conditions (hypertensive disease in pregnancy, reduced fetal growth (small for gestational age and fetal growth restriction) obstetric cholestasis, PPROM, previous history of stillbirth and recurrent reduced fetal movements )
• Able to give written informed consent.
• Willing to attend hospital immediately in the event of an unexpected finding whilst using the home devices.

You may not qualify if:

• Multiple pregnancy.
• Fetal abnormalities or a non-viable fetus.
• Body mass index (BMI) ≥35
• Women with internal cardiac devices such as pacemaker and implantable cardioverter defibrillator.
• History of allergic reaction to skin adhesives and/or latex.
• Acute or chronic skin lesions and wounds in areas in contact with the device.

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead

Study Sites (1)

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, B152TG, United Kingdom

RECRUITING

Study Officials

• Jack Hamer, MBChB

  Birmingham Women's and Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Hamer, MBChB

CONTACT

0121 472 1377; jack.hamer1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research fellow

Model Details: 50 participants split in one arm using the home CTG device. To detect a 20% difference in the mean anxiety scores pre- and post-study a sample size with a power of 90% (α =0.05), a sample size of 42 is required. 50 recruited women will allow for a 10% drop out rate.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 15, 2025
• Study Start: June 11, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)