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This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cheetah® non-invasive cardiac monitoring system | Experimental | Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum. |
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| Standard of care | Other | 24 hours of postpartum magnesium sulfate (current arbitrary standard of care) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cheetah® non-invasive cardiac monitoring system | Device | Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR)) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate. | up to 24 hours postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Postpartum Adverse Outcomes | any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as >160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maged Costantine, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cheetah® Non-invasive Cardiac Monitoring System | Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum. Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR)) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 31, 2022 |
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| Standard of care | Other | 24 hours of postpartum magnesium sulfate |
|
| up to 4 weeks after delivery |
| Evaluating Incidence of Need to Restart Magnesium Sulfate | up to 1 week postpartum |
| Evaluating Number of Participants With Hospital Readmission for Preeclampsia | up to 4 weeks postpartum |
| Use of Acute Anti-hypertensive Medications | Up to 5 days after delivery |
| Need for More Than 1 Dose of Anti-hypertensive Medication | Up to 5 days after delivery |
| FG001 | Standard of Care | 24 hours of postpartum magnesium sulfate (current arbitrary standard of care) Standard of care: 24 hours of postpartum magnesium sulfate |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cheetah® Non-invasive Cardiac Monitoring System | Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum. Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR)) |
| BG001 | Standard of Care | 24 hours of postpartum magnesium sulfate (current arbitrary standard of care) Standard of care: 24 hours of postpartum magnesium sulfate |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Nulliparity | Count of Participants | Participants |
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| BMI at delivery | Mean | Standard Deviation | Kg/m2 |
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| Gestational age at delivery | Median | Inter-Quartile Range | weeks |
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| 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 | Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate. | Posted | Mean | Standard Deviation | hours | up to 24 hours postpartum |
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| Secondary | Composite of Postpartum Adverse Outcomes | any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as >160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia | Posted | Count of Participants | Participants | up to 4 weeks after delivery |
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| Secondary | Evaluating Incidence of Need to Restart Magnesium Sulfate | Posted | Count of Participants | Participants | up to 1 week postpartum |
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| Secondary | Evaluating Number of Participants With Hospital Readmission for Preeclampsia | Posted | Count of Participants | Participants | up to 4 weeks postpartum |
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| Secondary | Use of Acute Anti-hypertensive Medications | Posted | Count of Participants | Participants | Up to 5 days after delivery |
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| Secondary | Need for More Than 1 Dose of Anti-hypertensive Medication | Posted | Count of Participants | Participants | Up to 5 days after delivery |
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After up to 4 weeks postpartum
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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 | Cheetah® Non-invasive Cardiac Monitoring System | Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum. Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR)) | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | Standard of Care | 24 hours of postpartum magnesium sulfate (current arbitrary standard of care) Standard of care: 24 hours of postpartum magnesium sulfate | 0 | 26 | 0 | 26 | 0 | 26 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maged Costantine, MD | The Ohio State University | 614-293-2222 | Maged.Costantine@osumc.edu |
| May 10, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| White race |
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| Hispanic ethnicity |
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| Participants |
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