Safety and Performance of a Fetal Monitoring System (M•CARE SE)

May 20, 2024 updated by: Marani Health

Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able to provide informed consent and follow study instructions
  • 18 years of age or older
  • Pregnant subjects ≥ 32 weeks' gestation
  • Singleton pregnancy
  • BMI ≥15, pre-pregnancy
  • BMI ≤45, pre-pregnancy
  • Belly circumference ≥80 cm and ≤ 130 cm

Exclusion Criteria:

  • Known major fetal malformation or chromosome abnormality
  • Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation
  • Participants with implanted electronic devices (pacemakers, defibrillator, etc.)
  • Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
  • Medical or obstetric problem that in the investigator's opinion would make the participant incapable of taking part in the study
  • In the investigator's opinion, the participant is not likely to be available for the minimum 60 minutes of the monitoring session
  • History of skin allergies to cosmetics and lotions
  • Known allergies to silver, nylon, or polyester

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M•care™ System + CTG
The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Heart Rate (FHR)
Time Frame: Up to 120 minutes
FHR as measured by the M•care System versus standard of care CTG device
Up to 120 minutes
Maternal Heart Rate (MHR)
Time Frame: Up to 120 minutes
MHR as measured by the M•care System versus standard of care CTG device
Up to 120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine Contractions (UC)
Time Frame: Up to 120 minutes
UC sensitivity as measured by the M•care System versus standard of care CTG device, where sensitivity is defined as the proportion of UC events identified by standard of care that are simultaneously identified by the M•care System (positive agreement).
Up to 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marani Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Actual)

January 24, 2023

Study Completion (Actual)

January 24, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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