NCT05294211CompletedNot Applicable
Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study
Marani Health1 site in 1 country120 target enrollmentStarted: August 31, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Fetal Heart Rate (FHR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
M•care™ System + CTG
Experimental
The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
Intervention: M•care™ System (Device)
M•care™ System + CTG
Experimental
The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
Intervention: Cardiotocography (CTG) (Device)
Outcomes
Primary Outcomes
Fetal Heart Rate (FHR)
Time Frame: Up to 120 minutes
FHR as measured by the M•care System versus standard of care CTG device
Maternal Heart Rate (MHR)
Time Frame: Up to 120 minutes
MHR as measured by the M•care System versus standard of care CTG device
Secondary Outcomes
- Uterine Contractions (UC)(Up to 120 minutes)
Investigators
Study Sites (1)
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