Femom System Compared to the Standard of Care CTG

NCT06490471 | Not Yet Recruiting

• 1 other identifier: 202404OSU01
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• FHR

  The 95% confidence limits for the 95% limits of agreement (LoA) for FHR are within -10 and 10 bpm

  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

  From 32 weeks gestation to labour

• PPA

  The positive percentage agreement (PPA) for UA using femom with respect to Tocodynamometry (TOCO).

  From 32 weeks gestation to labour

Secondary Outcomes (1)

• Femom NST vs NST

  From 32 weeks gestation to labour

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with singleton gestation \> 32+0 weeks of pregnancy

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Biorithm Pte Ltd: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share