Pregnancy RelatedNCT06490471
Femom System Compared to the Standard of Care CTG
An observational study of Pregnancy Related, run by Biorithm Pte Ltd.
Trial summary
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation > 32+0 weeks of pregnancy. 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
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 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: Pregnant women with singleton gestation > 32+0 weeks of pregnancy
Who may be able to join
- Female age between 18-50-year-old
- Singleton pregnancy.
- Should be at and above 32+0 weeks of pregnancy.
- Able to speak and read English to understand and sign the Informed Consent.
Who cannot join
- Participants with an intellectual or mental impairment.
- Participants with a known allergy or hypersensitivity to ECG gel electrodes.
- Known fetal cardiac or genetic abnormality.
- Clinically unstable participants who require immediate medical care.
- Participants 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.
- Participants with implantable electronic devices such as pacemaker or ICD.
- Participants with medical skin condition in the abdominal area (such as wounds, cuts in the skin, skin rash, etc.)
About this study
Official title: A Clinical Study Evaluating the Safety and Performance of the Femom System Compared to the Standard of Care CTG for Antepartum Fetal Monitoring.
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation > 32+0 weeks of pregnancy. The main questions it aims to answer are to assess the agreement between femom data collection (FHR, MHR, UA), and values measured via the standard of care used for prenatal monitoring (i.e. CTG). The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces.
Participants will have the femom device and CTG attached to their abdomen. The femom device will be attached for about 30 minutes while they are wearing the device for the NST.
- Conditions
- Pregnancy Related
What is being measured
The primary outcome is the main question the study is designed to answer.
FHR
The 95% confidence limits for the 95% limits of agreement (LoA) for FHR are within
-10 and 10 bpm
Measured: From 32 weeks gestation to labour
MHR
The 95% confidence limits for the 95% limits of agreement (LoA) for MHR are within
-8 and 8 bpm
Measured: From 32 weeks gestation to labour
PPA
The positive percentage agreement (PPA) for UA using femom with respect to Tocodynamometry (TOCO).
Measured: From 32 weeks gestation to labour
Secondary outcomes (1)
Femom NST vs NST
To test concordance in clinical interpretability of femom NST traces and the standard of care CTG traces.
Measured: From 32 weeks gestation to labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biorithm Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490471
- Sponsor's protocol ID
- 202404OSU01
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Performance of the Femom System Compared to the Standard of Care CTG for Antepartum Fetal Monitoring.
- ClinicalTrials.gov ID
- NCT06490471
- Acronym / sponsor ID
- 202404OSU01
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Biorithm Pte LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 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.
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation > 32+0 weeks of pregnancy. The main questions it aims to answer are to assess the agreement between femom data collection (FHR, MHR, UA), and values measured via the standard of care used for prenatal monitoring (i.e. CTG). The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces.
Participants will have the femom device and CTG attached to their abdomen. The femom device will be attached for about 30 minutes while they are wearing the device for the NST.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with singleton gestation > 32+0 weeks of pregnancy
Key inclusion criteria (4 listed)
- Female age between 18-50-year-old
- Singleton pregnancy.
- Should be at and above 32+0 weeks of pregnancy.
- Able to speak and read English to understand and sign the Informed Consent.
Key exclusion criteria (7 listed)
- Participants with an intellectual or mental impairment.
- Participants with a known allergy or hypersensitivity to ECG gel electrodes.
- Known fetal cardiac or genetic abnormality.
- Clinically unstable participants who require immediate medical care.
- Participants 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: From 32 weeks gestation to labour
The 95% confidence limits for the 95% limits of agreement (LoA) for FHR are within -10 and 10 bpm
MHR
Time frame: From 32 weeks gestation to labour
The 95% confidence limits for the 95% limits of agreement (LoA) for MHR are within -8 and 8 bpm
PPA
Time frame: From 32 weeks gestation to labour
The positive percentage agreement (PPA) for UA using femom with respect to Tocodynamometry (TOCO).
1 secondary outcome
Femom NST vs NST
Time frame: From 32 weeks gestation to labour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Biorithm Pte Ltd.
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 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
FHR (time frame: From 32 weeks gestation to labour). The study lists 3 primary outcomes in all. 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 8 Jul 2024.