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

Marani Health

Status

Completed

Conditions

Pregnancy

Treatments

Device: M•care™ System

Device: Cardiotocography (CTG)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05294211

MH-001

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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