Femom System Compared to the Standard of Care CTG

Not yet recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT06490471
• Lead Sponsor: Biorithm Pte Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FHR	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	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	From 32 weeks gestation to labour	The positive percentage agreement (PPA) for UA using femom with respect to Tocodynamometry (TOCO).

Secondary Outcome Measures

Name	Time	Method
Femom NST vs NST	From 32 weeks gestation to labour	To test concordance in clinical interpretability of femom NST traces and the standard of care CTG traces.