Femom System Compared to the Standard of Care CTG

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.)

Treatment and study plan

Primary outcomes

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).

Secondary outcomes

Femom NST vs NST

Time frame: From 32 weeks gestation to labour

To test concordance in clinical interpretability of femom NST traces and the standard of care CTG traces.

Sponsors and collaborators

Lead sponsor

Biorithm Pte Ltd

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 8, 2024
Registry last updated: Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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