Pregnancy RelatedNCT06497205
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
An observational study of Pregnancy Related, run by Biorithm Pte Ltd at 1 site in United Kingdom.
Trial summary
This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely. The main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2024to 31 Aug 2025
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women booked for antenatal care at St. George's hospital or women under the care of the Fetal medicine unit at St. George's hospital will be invited to participate in this study.
Who may be able to join
- Singleton live pregnancy
- > 26 weeks gestational age
- Able to speak English or available NHS interpreter
Who cannot join
- Women below 18 years of age
- Women with an intellectual or mental impairment
- Women with a known allergy or hypersensitivity to ECG gel electrodes
- Known fetal cardiac or genetic abnormality.
- Patient with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
- Inability to access interpreter.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Georges University Hospital
London, Tooting, SW17 0QT
Claire Pegorie, MBBS, +447557803882, Claire.Pegorie00@stgeorges.nhs.uk
About this study
This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.
The main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.
Read the detailed description
The Femom device is a non-invasive fetal ECG (NIFECG) device which has been developed for self application and remote monitoring. Women from three different cohort groups (controls, FGR and insulin dependent diabetes) will be approached and asked to monitor their baby at home once a day. Women in the control group will be asked to do this once a day for one week, the FGR pregnancies until delivery and the insulin dependent diabetics just from 36 weeks until delivery.
The data will be collected and analysed retrospectively to assess compliance of the participants with the study protocol, signal quality and establish reference standards in relation to gestation within the control group. Heart rate variability measures in the FGR and diabetes arm will be compared to the reference standards in the control group. Outcomes of the pregnancy.
Feedback regarding the usability of the device will also be collected using a feedback questionnaire to assess the feasibility of home antenatal monitoring.
- Conditions
- Pregnancy Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | low risk ASPRE | |
| FGR Group | FGR according to definition of ISUOG | |
| Diabetic Group | insulin dependent diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
FHR
FHR agreement between Femom system and standard of care (CTG)
Measured: 60 minutes
MHR
MHR agreement between Femom system and standard of care (CTG)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start19 Mar 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
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 RelatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biorithm Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amarnath Bhide, MBBS, PHD, Principal investigator, St Georges University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497205
- Sponsor's protocol ID
- AMBER2
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pegorie C, Liu B, Thilaganathan B, Bhide A. Ambulatory foetal ECG monitoring in low and high-risk pregnancies (AMBER2): a prospective cohort study protocol. BMJ Open. 2025 Sep 28;15(9):e096123. doi: 10.1136/bmjopen-2024-096123.
PubMed 41022451
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
- ClinicalTrials.gov ID
- NCT06497205
- Acronym / sponsor ID
- AMBER2
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Biorithm Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 11 Jul 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.
This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.
The main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.
Detailed description
The Femom device is a non-invasive fetal ECG (NIFECG) device which has been developed for self application and remote monitoring. Women from three different cohort groups (controls, FGR and insulin dependent diabetes) will be approached and asked to monitor their baby at home once a day. Women in the control group will be asked to do this once a day for one week, the FGR pregnancies until delivery and the insulin dependent diabetics just from 36 weeks until delivery.
The data will be collected and analysed retrospectively to assess compliance of the participants with the study protocol, signal quality and establish reference standards in relation to gestation within the control group. Heart rate variability measures in the FGR and diabetes arm will be compared to the reference standards in the control group. Outcomes of the pregnancy.
Feedback regarding the usability of the device will also be collected using a feedback questionnaire to assess the feasibility of home antenatal monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –low risk ASPRE |
| FGR Group | – | –FGR according to definition of ISUOG |
| Diabetic Group | – | –insulin dependent diabetes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women booked for antenatal care at St. George's hospital or women under the care of the Fetal medicine unit at St. George's hospital will be invited to participate in this study.
Key inclusion criteria (3 listed)
- Singleton live pregnancy
- > 26 weeks gestational age
- Able to speak English or available NHS interpreter
Key exclusion criteria (6 listed)
- Women below 18 years of age
- Women with an intellectual or mental impairment
- Women with a known allergy or hypersensitivity to ECG gel electrodes
- Known fetal cardiac or genetic abnormality.
- Patient with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FHR
Time frame: 60 minutes
FHR agreement between Femom system and standard of care (CTG)
MHR
Time frame: 60 minutes
MHR agreement between Femom system and standard of care (CTG)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 41022451Pegorie C, Liu B, Thilaganathan B, Bhide A. Ambulatory foetal ECG monitoring in low and high-risk pregnancies (AMBER2): a prospective cohort study protocol. BMJ Open. 2025 Sep 28;15(9):e096123. doi: 10.1136/bmjopen-2024-096123.
- 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.
Amarnath Bhide, MBBS, PHD principal investigator
St Georges University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Biorithm Pte Ltd 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 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vilasini Nair (+659628109, vilanair@bio-rithm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FHR (time frame: 60 minutes). 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 NCT06497205, 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 11 Jul 2024.