Status:
COMPLETED
Safety and Performance of a Fetal Monitoring System
Lead Sponsor:
Marani Health
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05294211
Start Date
August 31 2022
End Date
January 24 2023
Last Update
May 23 2024
Active Locations (1)
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1
NorthShore University Health System
Evanston, Illinois, United States, 60201