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NCT Number: NCT07124325

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

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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Key information

Conditions

Pregnancy Cardiotocography High Risk Telemedicine Telemonitoring

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, B152TG, United Kingdom

Location status: Recruiting

Location contact

Jack Hamer

CONTACT

[email protected]

0121 472 1377

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregnabit Pro device and PregnaOne platform

Device

Remote CTG device and online dashboard for remote pregnancy care

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: Through study completion, an average of 9 months

    Determined as the median number of monitoring episodes completed.

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

    Time frame: Pre-intervention

    Number participants agreeing out of total women approached

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

    Time frame: Pre-intervention

    Pre-intervention questionnaire using the accredited STAI anxiety questionnaire.

  4. 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

    Questionnaire using the accredited STAI anxiety questionnaire at several time points whilst using the home monitoring device. Results compared pre and post monitoring episode to determine a if there is a discriminative impact on anxiety scores whilst using the home monitoring device. Results will be displayed graphically and compared using P value.

  5. 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

    Post-intervention questionnaire using the accredited STAI anxiety questionnaire. Results compared to the scores at the beginning of the study and demonstrated graphically and with a P value.

  6. The usability of the remote monitoring device.

    Time frame: Immediately after the end of the intervention

    Assessed post study using the validated system usability scale scoring questionnaire.

  7. 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

    Number of unexpected outcomes requiring attendance to triage out of total number of monitoring episodes, presented as a percentage.

  8. What are the views of participants regarding acceptability of home maternal-fetal monitoring.

    Time frame: Pre-intervention

    Pre-intervention questionnaire using a 5 point Likert Scale (range from Strongly agree on the left, to strongly disagree on the right). No total score, each question individual and a tick box.

  9. What are the views of participants regarding acceptability of home maternal-fetal monitoring.

    Time frame: Immediately after the intervention

    Post-intervention questionnaire using a 5 point Likert Scale (range from Strongly agree on the left, to strongly disagree on the right). No total score, each question individual and a tick box.

  10. The influence of participant demographics on achieving the primary outcome.

    Time frame: Through study completion, an average of 9 months

    Analysis of factors which may influence achievement of the primary outcome. This includes ethnicity, education level, fetal presentation, parity. Presented as event numbers to calculated odds ratio's.

  11. Determining participant adherence to commencing the monitoring episodes

    Time frame: Through study completion, an average of 9 months

    Defined as the median time between when the participant commencing the monitoring episode and the time originally agreed to commence the monitoring episode previously jointly agreed between the researchers and participant.

  12. The influence of fetal movements on achieving the primary outcome

    Time frame: Through study completion, an average of 9 months

    Analysis of fetal movements during a monitoring episode and its influence on the primary outcome. Number of movements in the group achieving primary outcome compared to the group not achieving the primary outcome will be compared using the student T test.

Study contacts

Contact information is provided by the study sponsor or research team.

Jack Hamer, MBChB

CONTACT

[email protected]

0121 472 1377

Sponsors and collaborators

Lead sponsor

Birmingham Women's NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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