Pregnancy Clinical Trial
— M•CARE SEOfficial title:
Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study
NCT number | NCT05294211 |
Other study ID # | MH-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 31, 2022 |
Est. completion date | January 24, 2023 |
Verified date | January 2024 |
Source | Marani Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University Health System | Evanston | Illinois |
Lead Sponsor | Collaborator |
---|---|
Marani Health |
United States,
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 |
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