Trial Outcomes & Findings for Safety and Performance of a Fetal Monitoring System (NCT NCT05294211)

NCT ID: NCT05294211

Last Updated: 2024-05-23

Results Overview

FHR as measured by the M•care System versus standard of care CTG device

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

Up to 120 minutes

Results posted on

2024-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	M•Care™ System + CTG Single-arm study: All subjects were monitored with both the M•wrap and the CTG reference device simultaneously for fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UC) After enrollment, the presence of FHR and MHR was confirmed by completing a 5-minute monitoring session with the M•care System. If a valid signal was detected, a 30-minute session was initiated in which both systems (M•care and CTG) simultaneously recorded FHR, MHR, and UC data. Up to four monitoring sessions were completed depending on the availability of the subject.
Overall Study STARTED	120
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	M•Care™ System + CTG Single-arm study: All subjects were monitored with both the M•wrap and the CTG reference device simultaneously for fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UC) After enrollment, the presence of FHR and MHR was confirmed by completing a 5-minute monitoring session with the M•care System. If a valid signal was detected, a 30-minute session was initiated in which both systems (M•care and CTG) simultaneously recorded FHR, MHR, and UC data. Up to four monitoring sessions were completed depending on the availability of the subject.
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	2
Overall Study Progressed to active labor	1
Overall Study Did not complete 5-minute monitoring session	15
Overall Study Did not have ≥ 1 minute of concurrent data	19

Baseline Characteristics

Safety and Performance of a Fetal Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	M•Care™ System + CTG n=80 Participants 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31.7 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 120 minutes

Population: The performance evaluable population was defined as the population of subjects who had at least one minute of concurrent data collection with both devices (M•care and CTG) and did not have any major protocol violations. Of the 80 subjects in the performance evaluable population, no FHR data are available for one subject.

FHR as measured by the M•care System versus standard of care CTG device

Outcome measures

Outcome measures
Measure	M•Care™ System n=79 Participants The M•care System was applied for fetal and maternal monitoring	Cardiotocography (CTG) n=79 Participants A Philips Avalon FM30 or FM50 (CTG) was applied for fetal and maternal monitoring
Fetal Heart Rate (FHR)	140.1 BPM Standard Deviation 11.4	140.0 BPM Standard Deviation 10.7

PRIMARY outcome

Timeframe: Up to 120 minutes

MHR as measured by the M•care System versus standard of care CTG device

Outcome measures

Outcome measures
Measure	M•Care™ System n=79 Participants The M•care System was applied for fetal and maternal monitoring	Cardiotocography (CTG) n=79 Participants A Philips Avalon FM30 or FM50 (CTG) was applied for fetal and maternal monitoring
Maternal Heart Rate (MHR)	83.4 BPM Standard Deviation 12.0	83.1 BPM Standard Deviation 12.1

SECONDARY outcome

Timeframe: Up to 120 minutes

Population: Of the 80 subjects in the performance evaluable population, no uterine contraction (UC) data are available for two subjects. To compare sensitivity (positive agreement) in UC events between M•care and standard of care, bootstrap resampling techniques were used to account for the correlation among repeated UC measurements within subjects. Results for the M•care System and CTG are combined due to the outcome measure of UC sensitivity (positive agreement).

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).

Outcome measures

Outcome measures
Measure	M•Care™ System n=78 Participants The M•care System was applied for fetal and maternal monitoring	Cardiotocography (CTG) A Philips Avalon FM30 or FM50 (CTG) was applied for fetal and maternal monitoring
Uterine Contractions (UC)	0.57 proportion of true positives Interval 0.5 to 0.63	—

Adverse Events

M•Care™ System + CTG

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	M•Care™ System + CTG n=120 participants at risk 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)
Skin and subcutaneous tissue disorders erythema	0.83% 1/120 • Number of events 1 • 3 hours ISO 14155:2020 definitions of adverse event and serious adverse event were used.

Additional Information

Vice President, Clinical Affairs

Marani Health, Inc.

Phone: 612-718-9699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place