Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07124325

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

Led by Birmingham Women's NHS Foundation Trust · Updated on 2025-08-15

50

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, United Kingdom, B152TG

Actively Recruiting

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Research Team

J

Jack Hamer, MBChB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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