Safety and Performance of a Fetal Monitoring System

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.

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