Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy High Risk Telemonitoring Telemedicine Cardiotocography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Home antenatal CTG monitoring

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.

Group Type EXPERIMENTAL

Pregnabit Pro device and PregnaOne platform

Intervention Type DEVICE

Remote CTG device and online dashboard for remote pregnancy care

Interventions

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Pregnabit Pro device and PregnaOne platform

Remote CTG device and online dashboard for remote pregnancy care

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes