An interventional study of Pregnabit Pro device and PregnaOne platform in Pregnancy, High Risk and Telemonitoring, sponsored by Birmingham Women's NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Birmingham Women's NHS Foundation Trust · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
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
Remote CTG device and online dashboard for remote pregnancy care
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.
Time frame: Through study completion, an average of 9 months
The number of participants completing the full schedule of home maternal-fetal monitoring episodes.
Determined as the median number of monitoring episodes completed.
Time frame: Through study completion, an average of 9 months
The number of women approached who agreed to participate within the study.
Number participants agreeing out of total women approached
Time frame: Pre-intervention
What are the emotions of participants using home maternal-fetal monitoring.
Pre-intervention questionnaire using the accredited STAI anxiety questionnaire.
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?
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.
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.
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.
Time frame: Immediately after the intervention
The usability of the remote monitoring device.
Assessed post study using the validated system usability scale scoring questionnaire.
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.
Number of unexpected outcomes requiring attendance to triage out of total number of monitoring episodes, presented as a percentage.
Time frame: Through study completion, an average of 9 months
What are the views of participants regarding acceptability of home maternal-fetal monitoring.
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.
Time frame: Pre-intervention
What are the views of participants regarding acceptability of home maternal-fetal monitoring.
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.
Time frame: Immediately after the intervention
The influence of participant demographics on achieving the primary outcome.
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.
Time frame: Through study completion, an average of 9 months
Determining participant adherence to commencing the monitoring episodes
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.
Time frame: Through study completion, an average of 9 months
The influence of fetal movements on achieving the primary outcome
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.
Time frame: Through study completion, an average of 9 months
Plan to share: No
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Birmingham Women's NHS Foundation Trust