An interventional study of Pregnabit Pro device and PregnaOne platform and Pulsenmore device in Pregnancy, High Risk, Telemonitoring and Telemedicine, sponsored by Birmingham Women's NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Birmingham Women's NHS Foundation Trust · Not applicable, Interventional, and Device feasibility
During pregnancy, certain conditions may arise that mean regular monitoring of both mother and baby are needed to ensure timely interventions and avoid the need for further treatments. These situations include problems with high blood pressure, obstetric cholestasis (characterised by liver-related itchiness), preterm premature rupture of membranes (PPROM), and a history of stillbirth. Monitoring typically involves assessing the mother's blood pressure and urine, recording the baby's heart rate over a specific duration, and conducting regular ultrasound scans. Such monitoring can require frequent hospital visits, often multiple times a week, which can be very time consuming. More recently, new technology has emerged, enabling remote monitoring of mother and baby outside of the hospital setting, such as their own home. However, research on these technologies is still very limited.
Our study aims to address this research gap by inviting women with the above conditions to volunteer for home-based monitoring, alongside their routine hospital care. Participants will be divided into three groups: one group will use transducers, attached to the mothers tummy, to capture the baby's heartbeat; another group will use a handheld ultrasound device connected to their mobile phones, allowing them to observe the baby; and a third group will use both devices. All device information will be transmitted securely to the healthcare professional for analysis. The investigators aim to assess the feasibility of conducting remote monitoring of mother and baby, whilst understanding how acceptable the technology is received.
Importantly, the data collected will only be evaluated by the research team and will not be intended to influence patient's current planned antenatal care. Women will receive comprehensive training on the devices. The study will additionally gather feedback from participating women through questionnaires, both at the study's outset and its conclusion, regarding their experiences and emotions related to the research.
The primary 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 pregnant women.
Pregnant women from 32+0 weeks' gestation onwards receiving regular outpatient antenatal care including routine ultrasound and CTG monitoring on the Day Assessment Unit (DAU) at the Birmingham Women's hospital (BWH). They will continue their regular antenatal care whilst using the devices.
Following consent, participants will be provided with the home monitoring equipment including a face-to-face education session on their usage. A schedule for home monitoring will be agreed. Participants will be asked to complete a short questionnaire about their views and expectations of home telemetry, including some basic patient characteristics.
The recordings will be uploaded automatically and wirelessly to the respective online clinical dashboards, whereby two members of the research team will securely review the images contemporaneously.
End of participation:
Upon completion, equipment will be collected, and participants will be asked to complete a short exit questionnaire about the usability, reassurance, feelings of control and overall feedback. Additionally, patients will repeat the GAD-7 anxiety questionnaire.
End of study:
All data will be formally collated and analysed with respect to the above study outcomes, enabling the research team to retrieve an overall determination as to whether these devices are feasible and acceptable for the pregnancy population.
Exclusion Criteria:
Participants will be asked to use the remote monitoring devices twice a week, on mutually agreed days for a minimum of 30 minutes each time. Ideally participants will use the home CTG monitor for at least a four-week period or until delivery.
Device: Pregnabit Pro device and PregnaOne platform
Participants will be asked to use the remote monitoring devices once a fortnight, on mutually agreed days for the duration by which the scan has been completed. Ideally participants will use the home ultrasound monitor for at least a 8-week period or until delivery.
Drug: Pulsenmore device
Follow both device plans above.
Device: Pregnabit Pro device and PregnaOne platform · Drug: Pulsenmore device
Remote CTG device for pregnancy care
Remote ultrasound device for pregnancy care
The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring.
Ultrasound scans will be assessed upon the criterion that the device is currently licensed for: fetal movements, fetal heartbeat and an objective assessment of the liquor volume.
Time frame: Through study completion, an average of 6 months
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.
Time frame: Through study completion, an average of 6 months
The number of participants completing the full schedule of home maternal-fetal monitoring episodes.
Number of monitoring episodes out of total episodes desired at study onset.
Time frame: Through study completion, an average of 6 months
To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home?
Questionnaires
Time frame: 6 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 views of participants and healthcare professionals 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 and healthcare professional 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
What are the emotions of participants prior to and following usage of home maternal-fetal monitoring.
Pre-intervention questionnaire using the accredited GAD-7 anxiety questionnaire. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Time frame: Pre-intervention
What are the emotions of participants prior to and following usage of home maternal-fetal monitoring.
Post-intervention questionnaire using the accredited GAD-7 anxiety questionnaire. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Time frame: Immediately after 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 out of total number of monitoring episodes
Time frame: Through study completion, an average of 6 months
Plan to share: No
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Birmingham Women's NHS Foundation Trust