PregnancyNCT04941534
This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.
An observational study of Pregnancy, run by Biorithm Pte Ltd at 1 site in United Kingdom.
Trial summary
This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2021to 30 Jul 2022
- 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
- Adult
Study population: Participants would be recruited at the Day Assessment Unit who require CTG monitoring and meet the inclusion criteria
Who may be able to join
- Have a singleton pregnancy
- Should be at and above 28 weeks of pregnancy
- Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy
- Able to speak English or have access to an interpreter and provide Informed Consent
Who cannot join
- Participants with an intellectual or mental impairment
- Participants with a known allergy or hypersensitivity to ECG gel electrodes
- Participants in pain, with contractions or in labour
- Known fetal cardiac or genetic abnormality
- Participant with a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AMBulatory Fetal ECG Monitoring in High Risk Pregnancies
This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.
Read the detailed description
The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.
- Conditions
- Pregnancy
- Keywords
- antepartum monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Heart Rate (FHR)
FHR agreement between Biorithm Research Kit and standard of care (CTG)
Measured: 60 minutes
Maternal Heart Rate (MHR)
MHR agreement between Biorithm Research Kit 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 posted28 Jun 2021
- Study start4 Jun 2021
- Primary completion22 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biorithm Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baskaran Thilaganathan, Principal investigator, St George's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941534
- Sponsor's protocol ID
- AMBER
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
Publications
Liu B, Marler E, Thilaganathan B, Bhide A. Ambulatory antenatal fetal electrocardiography in high-risk pregnancies (AMBER): protocol for a pilot prospective cohort study. BMJ Open. 2023 Apr 13;13(4):e062448. doi: 10.1136/bmjopen-2022-062448.
PubMed 37055213Liu B, Thilaganathan B, Bhide A. Effectiveness of ambulatory non-invasive fetal electrocardiography: impact of maternal and fetal characteristics. Acta Obstet Gynecol Scand. 2023 May;102(5):577-584. doi: 10.1111/aogs.14543. Epub 2023 Mar 21.
PubMed 36944583
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMBulatory Fetal ECG Monitoring in High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT04941534
- Acronym / sponsor ID
- AMBER
- Conditions
- Pregnancy
- Keywords
- antepartum monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Biorithm Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 28 Jun 2021 (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 clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.
Detailed description
The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Participants would be recruited at the Day Assessment Unit who require CTG monitoring and meet the inclusion criteria
Key inclusion criteria (4 listed)
- Have a singleton pregnancy
- Should be at and above 28 weeks of pregnancy
- Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy
- Able to speak English or have access to an interpreter and provide Informed Consent
Key exclusion criteria (5 listed)
- Participants with an intellectual or mental impairment
- Participants with a known allergy or hypersensitivity to ECG gel electrodes
- Participants in pain, with contractions or in labour
- Known fetal cardiac or genetic abnormality
- Participant with a pacemaker
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
Fetal Heart Rate (FHR)
Time frame: 60 minutes
FHR agreement between Biorithm Research Kit and standard of care (CTG)
Maternal Heart Rate (MHR)
Time frame: 60 minutes
MHR agreement between Biorithm Research Kit and standard of care (CTG)
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 8 Feb 2023.
- Derived from this study: PubMed 37055213Liu B, Marler E, Thilaganathan B, Bhide A. Ambulatory antenatal fetal electrocardiography in high-risk pregnancies (AMBER): protocol for a pilot prospective cohort study. BMJ Open. 2023 Apr 13;13(4):e062448. doi: 10.1136/bmjopen-2022-062448.
- Derived from this study: PubMed 36944583Liu B, Thilaganathan B, Bhide A. Effectiveness of ambulatory non-invasive fetal electrocardiography: impact of maternal and fetal characteristics. Acta Obstet Gynecol Scand. 2023 May;102(5):577-584. doi: 10.1111/aogs.14543. Epub 2023 Mar 21.
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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.
Baskaran Thilaganathan principal investigator
St George's University Hospital
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, 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 4 inclusion and 5 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 8 Feb 2023. 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?
Fetal Heart Rate (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 NCT04941534, which also lists 2 linked publications.
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 8 Feb 2023.