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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M•care™ System + CTG | Experimental | The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M•care™ System | Device | The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Heart Rate (FHR) | FHR as measured by the M•care System versus standard of care CTG device | Up to 120 minutes |
| Maternal Heart Rate (MHR) | MHR as measured by the M•care System versus standard of care CTG device | Up to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Performance evaluable population, as defined by 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fetal Heart Rate (FHR) | FHR as measured by the M•care System versus standard of care CTG device | 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. | Posted | Mean | Standard Deviation | BPM | Up to 120 minutes |
|
3 hours
ISO 14155:2020 definitions of adverse event and serious adverse event were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild erythema and skin irritation occurred after applying the exfoliating agent, prior to the use of the M•care System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Affairs | Marani Health, Inc. | 612-718-9699 | mindy@maranihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2022 | Jan 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015148 | Cardiotocography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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) |
|
| Did not complete 5-minute monitoring session |
|
| Did not have ≥ 1 minute of concurrent data |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Primary | Maternal Heart Rate (MHR) | MHR as measured by the M•care System versus standard of care CTG device | 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 MHR data are available for one subject. | Posted | Mean | Standard Deviation | BPM | 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). | 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). | Posted | Number | 95% Confidence Interval | proportion of true positives | Up to 120 minutes |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 1 |
| 120 |
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| D005323 | Fetal Monitoring |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D008991 | Monitoring, Physiologic |