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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related

• Study Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biorithm Pte Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202404OSU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No