At a glance
ClinicalIndex Comparison RecordN/ACompleted· 120 enrolled
Drug / intervention
M•care™ System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study
In Brief
A clinical study evaluating M•care™ System and Cardiotocography (CTG) for Pregnancy. Completed, enrolled 120 participants across 1 site.
Detailed 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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartAug 2022
Primary CompletionJan 2023
TodayJul 2026
First PostedMar 24, 2022
Enrollment StartAug 31, 2022
Primary CompletionJan 24, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.3 years ago
Interventions
M•care™ Systemdevice
The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Cardiotocography (CTG)device
A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)