Pregnancy, High RiskNCT06366711
Remote Telemedicine Fetal Monitoring Feasibility Study
A study testing Pregnabit Pro device and PregnaOne platform and Pulsenmore device in people with Pregnancy, High Risk and Telemonitoring, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk, Telemonitoring, Telemedicine
- What is being tested?
- Pregnabit Pro device and PregnaOne platform and Pulsenmore device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged ≥18 years
- Gestational age 32+0 weeks onwards.
- Singleton pregnancy.
- Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 4 index conditions (pregnancy induced hypertension (PIH), obstetric cholestasis, PPROM and previous history of stillbirth)
- Able to give written informed consent.
- Willing to attend hospital immediately in the event of an unexpected finding whilst using the home devices.
Who cannot join
- 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.
- Medical or midwifery concerns regarding maternal and/or fetal conditions such that inpatient care is recommended.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Antenatal Maternal-fetal Telemedicine Monitoring in High-risk Pregnancies: a Feasibility and Acceptability Study
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.
Read the detailed description
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.
- Home antenatal CTG monitoring using the Pregnabit Pro device and PregnaOne platform only - 5 participants.
- Home antenatal ultrasound monitoring using the Pulsenmore device only - 5 participants.
- Usage of both home antenatal ultrasound and CTG monitoring devices - 5 participants.
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.
- Home CTG monitoring - Pregnabit Pro device and PregnaOne platform: 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 device for at least a four-week period or until delivery.
- Home ultrasound monitoring - Pulsenmore: Participants will be asked to use the remote monitoring devices fortnightly, on mutually agreed days . Ideally participants will use the home ultrasound device for at least a eight-week period or until delivery.
- Both home CTG and ultrasound monitoring: Participants will follow both above device plans as noted above
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.
- Conditions
- Pregnancy, High Risk, Telemonitoring, Telemedicine, Ultrasound, Cardiotocography
- Being tested
- Pregnabit Pro device and PregnaOne platform, Pulsenmore device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnabit Pro device and PregnaOne platformDevice
Remote CTG device for pregnancy care
Pulsenmore deviceDrug
Remote ultrasound device for pregnancy care
| Study group | Role | What they receive |
|---|---|---|
| Home antenatal CTG monitoring | Experimental | 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. Receives: Device: Pregnabit Pro device and PregnaOne platform |
| Home antenatal ultrasound monitoring | Experimental | 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. Receives: Drug: Pulsenmore device |
| Usage of both home antenatal ultrasound and CTG monitoring devices | Experimental | Follow both device plans above. Receives: Device: Pregnabit Pro device and PregnaOne platform; Drug: Pulsenmore device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (8)
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.
Measured: 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
Measured: 6 months
The number of women approached who agreed to participate within the study.
Number participants agreeing out of total women approached
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start20 Jun 2024
- Primary completion1 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 15 participants split in to three arms. The sample size has been determined as a pragmatic sample taking into consideration the needs of the feasibility study to meet the stated objectives as well as being achievable within the time and cost constraints of the study. 15 participants will ensure a thorough assessment of the stated objectives.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- GE Healthcare, Nestmedic Spolka Akcyjna
- Responsible party
- Principal investigator, Jack Hamer, Birmingham Women's NHS Foundation Trust
- Investigators
- Leo Gurney, Study director, Birmingham Women's and Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366711
- Sponsor's protocol ID
- 23/BW/MAT/NO/754
- Status last verified
- Feb 2025
- First submitted
- 28 Mar 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Vance J, Emms A, Hodgetts Morton V, Morris RK, Gurney L. Remote maternal-fetal telemedicine monitoring for high-risk pregnancy care: A feasibility study. PLoS One. 2025 Nov 14;20(11):e0336797. doi: 10.1371/journal.pone.0336797. eCollection 2025.
PubMed 41237146
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Antenatal Maternal-fetal Telemedicine Monitoring in High-risk Pregnancies: a Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT06366711
- Acronym / sponsor ID
- 23/BW/MAT/NO/754
- Conditions
- Pregnancy, High Risk, Telemonitoring, Telemedicine, Ultrasound, Cardiotocography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Collaborators
- GE Healthcare, Nestmedic Spolka Akcyjna
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Home antenatal CTG monitoring using the Pregnabit Pro device and PregnaOne platform only - 5 participants.
- Home antenatal ultrasound monitoring using the Pulsenmore device only - 5 participants.
- Usage of both home antenatal ultrasound and CTG monitoring devices - 5 participants.
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.
- Home CTG monitoring - Pregnabit Pro device and PregnaOne platform: 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 device for at least a four-week period or until delivery.
- Home ultrasound monitoring - Pulsenmore: Participants will be asked to use the remote monitoring devices fortnightly, on mutually agreed days . Ideally participants will use the home ultrasound device for at least a eight-week period or until delivery.
- Both home CTG and ultrasound monitoring: Participants will follow both above device plans as noted above
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 15 participants split in to three arms. The sample size has been determined as a pragmatic sample taking into consideration the needs of the feasibility study to meet the stated objectives as well as being achievable within the time and cost constraints of the study. 15 participants will ensure a thorough assessment of the stated objectives.
| Arm | Type | Receives |
|---|---|---|
| Home antenatal CTG monitoring | Experimental | Device: Pregnabit Pro device and PregnaOne platformParticipants 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. |
| Home antenatal ultrasound monitoring | Experimental | Drug: Pulsenmore deviceParticipants 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. |
| Usage of both home antenatal ultrasound and CTG monitoring devices | Experimental | Device: Pregnabit Pro device and PregnaOne platform, Drug: Pulsenmore deviceFollow both device plans above. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged ≥18 years
- Gestational age 32+0 weeks onwards.
- Singleton pregnancy.
- Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 4 index conditions (pregnancy induced hypertension (PIH), obstetric cholestasis, PPROM and previous history of stillbirth)
- Able to give written informed consent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnabit Pro device and PregnaOne platformRemote CTG device for pregnancy care | Device | Home antenatal CTG monitoring, Usage of both home antenatal ultrasound and CTG monitoring devices |
| Pulsenmore deviceRemote ultrasound device for pregnancy care | Drug | Home antenatal ultrasound monitoring, Usage of both home antenatal ultrasound and CTG monitoring devices |
Primary outcome
The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring.
Time frame: Through study completion, an average of 6 months
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.
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 6 months
Completion of an at least 20 minutes of uninterrupted interpretable fetal heart recording which has computerised capability.
8 secondary outcomes
The number of participants completing the full schedule of home maternal-fetal monitoring episodes.
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?
Time frame: 6 months
The number of women approached who agreed to participate within the study.
Time frame: Pre-intervention
What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring.
Time frame: Pre-intervention
What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring.
Time frame: Immediately after the intervention
What are the emotions of participants prior to and following usage of home maternal-fetal monitoring.
Time frame: Pre-intervention
What are the emotions of participants prior to and following usage of home maternal-fetal monitoring.
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.
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 41237146Le Vance J, Emms A, Hodgetts Morton V, Morris RK, Gurney L. Remote maternal-fetal telemedicine monitoring for high-risk pregnancy care: A feasibility study. PLoS One. 2025 Nov 14;20(11):e0336797. doi: 10.1371/journal.pone.0336797. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leo Gurney study director
Birmingham Women's and Children's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnabit Pro device and PregnaOne platform and Pulsenmore device in people with Pregnancy, High Risk and Telemonitoring, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring. (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.