Safety and Performance of a Fetal Monitoring System

NCT05294211 | Completed Results

• 1 other identifier: MH-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

antenatal monitoring; fetal monitoring

Outcome Measures

Primary Outcomes (2)

• Fetal Heart Rate (FHR)

  FHR as measured by the M•care System versus standard of care CTG device

  Up to 120 minutes

• Maternal Heart Rate (MHR)

  MHR as measured by the M•care System versus standard of care CTG device

  Up to 120 minutes

Secondary Outcomes (1)

• Uterine Contractions (UC)

  Up to 120 minutes

Study Arms (1)

M•care™ System + CTG

EXPERIMENTAL

The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring

Device: M•care™ System; Device: Cardiotocography (CTG)

Interventions

M•care™ System DEVICE

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

M•care™ System + CTG

Cardiotocography (CTG) DEVICE

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

M•care™ System + CTG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent and follow study instructions
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marani Health: lead

Study Sites (1)

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Interventions

Cardiotocography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Fetal Monitoring; Diagnostic Techniques, Obstetrical and Gynecological; Monitoring, Physiologic

Results Point of Contact

• Title: Vice President, Clinical Affairs
• Organization: Marani Health, Inc.

mindy@maranihealth.com

612-718-9699

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: August 31, 2022
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: May 23, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)