PregnancyNCT07124325
Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care
A study testing Pregnabit Pro device and PregnaOne platform in people with Pregnancy and High Risk, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk, Telemonitoring
- What is being tested?
- Pregnabit Pro device and PregnaOne platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, B152TG
Jack Hamer, 0121 472 1377, jack.hamer1@nhs.net
About this study
Official title: The Use of 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.
- Conditions
- Pregnancy, High Risk, Telemonitoring, Telemedicine, Cardiotocography
- Being tested
- Pregnabit Pro device and PregnaOne platform
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 and online dashboard for remote pregnancy care
| Study group | Role | What they receive |
|---|---|---|
| Home antenatal CTG monitoring | Experimental | 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. Receives: Device: Pregnabit Pro device and PregnaOne platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 9 months
Secondary outcomes (12)
The number of participants completing the full schedule of home maternal-fetal monitoring episodes.
Determined as the median number of monitoring episodes completed.
Measured: 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
Measured: Pre-intervention
What are the emotions of participants using home maternal-fetal monitoring.
Pre-intervention questionnaire using the accredited STAI anxiety questionnaire.
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention
The usability of the remote monitoring device.
Assessed post study using the validated system usability scale scoring questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start11 Jun 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 50 participants split in one arm using the home CTG device. To detect a 20% difference in the mean anxiety scores pre- and post-study a sample size with a power of 90% (α =0.05), a sample size of 42 is required. 50 recruited women will allow for a 10% drop out rate.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jack Hamer, Birmingham Women's NHS Foundation Trust
- Investigators
- Jack Hamer, MBChB, Principal investigator, Birmingham Women's and Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124325
- Sponsor's protocol ID
- 27-6-194
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.
- ClinicalTrials.gov ID
- NCT07124325
- Acronym / sponsor ID
- 27-6-194
- Conditions
- Pregnancy, High Risk, Telemonitoring, Telemedicine, Cardiotocography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Aug 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 50 participants split in one arm using the home CTG device. To detect a 20% difference in the mean anxiety scores pre- and post-study a sample size with a power of 90% (α =0.05), a sample size of 42 is required. 50 recruited women will allow for a 10% drop out rate.
| Arm | Type | Receives |
|---|---|---|
| Home antenatal CTG monitoring | Experimental | Device: Pregnabit Pro device and PregnaOne platformParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 )
Key exclusion criteria (6 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 and online dashboard for remote pregnancy care | Device | Home antenatal CTG monitoring |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 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.
Jack Hamer, MBChB principal investigator
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 in people with Pregnancy and High Risk, 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jack Hamer, MBChB (0121 472 1377, jack.hamer1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.