Femom System Compared to the Standard of Care CTG

NCT ID: NCT06490471

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Female age between 18-50-year-old
2. Singleton pregnancy.
3. Should be at and above 32+0 weeks of pregnancy.
4. Able to speak and read English to understand and sign the Informed Consent.

Exclusion Criteria

1. Participants with an intellectual or mental impairment.
2. Participants with a known allergy or hypersensitivity to ECG gel electrodes.
3. Known fetal cardiac or genetic abnormality.
4. Clinically unstable participants who require immediate medical care.
5. 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.
6. Participants with implantable electronic devices such as pacemaker or ICD.
7. Participants with medical skin condition in the abdominal area (such as wounds, cuts in the skin, skin rash, etc.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biorithm Pte Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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202404OSU01

Identifier Type: -

Identifier Source: org_study_id

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