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Recruiting NCT07124325

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

No phase Interventional Pregnancy High Risk Telemonitoring Telemedicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pregnabit Pro device and PregnaOne platform.
Who it may be relevant to
Registry conditions: Pregnancy, High Risk, Telemonitoring, Telemedicine. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.

Overview

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.

Interventions

  • Device Pregnabit Pro device and PregnaOne platform
    Remote CTG device and online dashboard for remote pregnancy care

Primary outcome measures

  • The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring. [Time frame: Through study completion, an average of 9 months]
Secondary outcome measures (12)
  • The number of participants completing the full schedule of home maternal-fetal monitoring episodes. [Time frame: Through study completion, an average of 9 months]
  • The number of women approached who agreed to participate within the study. [Time frame: Pre-intervention]
  • What are the emotions of participants using home maternal-fetal monitoring. [Time frame: 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? [Time frame: 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. [Time frame: Immediately after the intervention]
  • The usability of the remote monitoring device. [Time frame: Immediately after the end of the intervention]
  • The number of participants with unexpected clinical outcomes detected whilst using home monitoring devices, which warrants patients to attend maternity triage for assessment and/or modification of ones antenatal care. [Time frame: Through study completion, an average of 9 months]
  • What are the views of participants regarding acceptability of home maternal-fetal monitoring. [Time frame: Pre-intervention]
  • What are the views of participants regarding acceptability of home maternal-fetal monitoring. [Time frame: Immediately after the intervention]
  • The influence of participant demographics on achieving the primary outcome. [Time frame: Through study completion, an average of 9 months]
  • Determining participant adherence to commencing the monitoring episodes [Time frame: Through study completion, an average of 9 months]
  • The influence of fetal movements on achieving the primary outcome [Time frame: Through study completion, an average of 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • Birmingham Women's and Children's NHS Foundation Trust — Birmingham

Identifiers

NCT: NCT07124325 · 27-6-194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗