Study Results
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View full resultsBasic Information
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COMPLETED
120 participants
INTERVENTIONAL
2022-08-31
2023-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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M•care™ System + CTG
The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
M•care™ System
The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Cardiotocography (CTG)
A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Interventions
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M•care™ System
The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Cardiotocography (CTG)
A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Marani Health
INDUSTRY
Responsible Party
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Locations
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NorthShore University Health System
Evanston, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MH-001
Identifier Type: -
Identifier Source: org_study_id
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