Safety and Performance of a Fetal Monitoring System

Pregnancy Clinical Trial

— M•CARE SE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294211
• Other study ID #: MH-001
• Status: Completed
• Start date: August 31, 2022
• Est. completion date: January 24, 2023

Study information

• Verified date: January 2024
• Source: Marani Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	NorthShore University Health System	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Marani Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Heart Rate (FHR)	FHR as measured by the M•care System versus standard of care CTG device	Up to 120 minutes
Primary	Maternal Heart Rate (MHR)	MHR as measured by the M•care System versus standard of care CTG device	Up to 120 minutes
Secondary	Uterine Contractions (UC)	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