Safety and Performance of a Fetal Monitoring System

Completed

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

• Registration Number: NCT05294211
• Lead Sponsor: Marani Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2022-08-31
• Primary Completion: 2023-01-24
• Study Completion: 2023-01-24
• Status Verified: 2024-01
• Results First Submitted: 2024-01-12
• Results First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Results First Posted: 2024-05-23
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
M•care™ System + CTG	M•care™ System	The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
M•care™ System + CTG	Cardiotocography (CTG)	The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring

Primary Outcome Measures

Name	Time	Method
Fetal Heart Rate (FHR)	Up to 120 minutes	FHR as measured by the M•care System versus standard of care CTG device
Maternal Heart Rate (MHR)	Up to 120 minutes	MHR as measured by the M•care System versus standard of care CTG device

Secondary Outcome Measures

Name	Time	Method
Uterine Contractions (UC)	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).

Trial Locations

Locations (1)

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States