Femom System Compared to the Standard of Care CTG

A Clinical Study Evaluating the Safety and Performance of the Femom System Compared to the Standard of Care CTG for Antepartum Fetal Monitoring.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06490471

Enrollment

120

Registered

2024-07-08

Start date

2024-07-31

Completion date

2025-07-31

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results