An interventional study of Cheetah® non-invasive cardiac monitoring system and Standard of care in Preeclampsia With Severe Features, sponsored by Ohio State University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Ohio State University · Not applicable, Interventional, and Other
This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups:
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's enrollment of 53 is below the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Cheetah® non-invasive cardiac monitoring system
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Other: Standard of care
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))
24 hours of postpartum magnesium sulfate
Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
Time frame: up to 24 hours postpartum
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
Time frame: up to 4 weeks after delivery
Evaluating Incidence of Need to Restart Magnesium Sulfate
Time frame: up to 1 week postpartum
Evaluating Number of Participants With Hospital Readmission for Preeclampsia
Time frame: up to 4 weeks postpartum
Use of Acute Anti-hypertensive Medications
Time frame: Up to 5 days after delivery
Need for More Than 1 Dose of Anti-hypertensive Medication
Time frame: Up to 5 days after delivery
| Milestone | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care |
|---|---|---|
| Started | 21 | 26 |
| Completed | 21 | 26 |
| Not completed | 0 | 0 |
| hours | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care |
|---|---|---|
| Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate. | 21.6 ± 4.7 | 24 ± 0 |
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
| Participants | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care |
|---|---|---|
| Composite of Postpartum Adverse Outcomes | 6 | 7 |
| Participants | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care |
|---|---|---|
| Evaluating Incidence of Need to Restart Magnesium Sulfate | 0 | 0 |
| Participants | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care |
|---|---|---|
| Evaluating Number of Participants With Hospital Readmission for Preeclampsia | 0 | 1 |
| Participants | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care |
|---|---|---|
| Use of Acute Anti-hypertensive Medications | 6 | 7 |
| Participants | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care |
|---|---|---|
| Need for More Than 1 Dose of Anti-hypertensive Medication | 4 | 3 |
Collected over After up to 4 weeks postpartum. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cheetah® Non-invasive Cardiac Monitoring System | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Standard of Care | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Continuous(years) | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care | Total |
|---|---|---|---|
| Mean | 31 ± 5.5 | 30 ± 5.5 | 30.4 ± 5.46 |
| Sex: Female, Male(Participants) | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care | Total |
|---|---|---|---|
| Female | 21 | 26 | 47 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care | Total |
|---|---|---|---|
| Black race | 4 | 6 | 10 |
| White race | 17 | 20 | 37 |
| Hispanic ethnicity | 0 | 2 | 2 |
| Region of Enrollment(participants) | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care | Total |
|---|---|---|---|
| United States | 21 | 26 | 47 |
| Nulliparity(Participants) | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care | Total |
|---|---|---|---|
| Count of participants | 12 | 14 | 26 |
| BMI at delivery(Kg/m2) | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care | Total |
|---|---|---|---|
| Mean | 37.3 ± 7.7 | 39.1 ± 9.9 | 38.3 ± 8.9 |
| Gestational age at delivery(weeks) | Cheetah® Non-invasive Cardiac Monitoring System | Standard of Care | Total |
|---|---|---|---|
| Median | 36 (33 to 37) | 36 (34 to 38) | 36 (33.5 to 37.5) |
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Ohio State University