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Safety and Performance of a Fetal Monitoring System

NCT05294211 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-23

Study results available
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Summary

The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.

Conditions

  • Pregnancy

Interventions

DEVICE

M•care™ System

The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)

DEVICE

Cardiotocography (CTG)

A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)

Sponsors & Collaborators

  • Marani Health

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-01-24
Completion
2023-01-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05294211 on ClinicalTrials.gov