Trial Outcomes & Findings for Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia (NCT NCT04474704)
NCT ID: NCT04474704
Last Updated: 2023-06-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
up to 24 hours postpartum
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
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))
|
Standard of Care
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
26
|
|
Overall Study
COMPLETED
|
21
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
Baseline characteristics by cohort
| Measure |
Cheetah® Non-invasive Cardiac Monitoring System
n=21 Participants
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))
|
Standard of Care
n=26 Participants
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
30 years
STANDARD_DEVIATION 5.5 • n=107 Participants
|
30.4 years
STANDARD_DEVIATION 5.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black race
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White race
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
26 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Nulliparity
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
BMI at delivery
|
37.3 Kg/m2
STANDARD_DEVIATION 7.7 • n=99 Participants
|
39.1 Kg/m2
STANDARD_DEVIATION 9.9 • n=107 Participants
|
38.3 Kg/m2
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Gestational age at delivery
|
36 weeks
n=99 Participants
|
36 weeks
n=107 Participants
|
36 weeks
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours postpartumOutcome measures
| Measure |
Cheetah® Non-invasive Cardiac Monitoring System
n=21 Participants
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))
|
Standard of Care
n=26 Participants
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 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.
|
21.6 hours
Standard Deviation 4.7
|
24 hours
Standard Deviation 0
|
SECONDARY outcome
Timeframe: up to 4 weeks after deliveryany 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
Outcome measures
| Measure |
Cheetah® Non-invasive Cardiac Monitoring System
n=21 Participants
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))
|
Standard of Care
n=26 Participants
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate
|
|---|---|---|
|
Composite of Postpartum Adverse Outcomes
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 1 week postpartumOutcome measures
| Measure |
Cheetah® Non-invasive Cardiac Monitoring System
n=21 Participants
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))
|
Standard of Care
n=26 Participants
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate
|
|---|---|---|
|
Evaluating Incidence of Need to Restart Magnesium Sulfate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeks postpartumOutcome measures
| Measure |
Cheetah® Non-invasive Cardiac Monitoring System
n=21 Participants
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))
|
Standard of Care
n=26 Participants
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate
|
|---|---|---|
|
Evaluating Number of Participants With Hospital Readmission for Preeclampsia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days after deliveryOutcome measures
| Measure |
Cheetah® Non-invasive Cardiac Monitoring System
n=21 Participants
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))
|
Standard of Care
n=26 Participants
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate
|
|---|---|---|
|
Use of Acute Anti-hypertensive Medications
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days after deliveryOutcome measures
| Measure |
Cheetah® Non-invasive Cardiac Monitoring System
n=21 Participants
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))
|
Standard of Care
n=26 Participants
24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate
|
|---|---|---|
|
Need for More Than 1 Dose of Anti-hypertensive Medication
|
4 Participants
|
3 Participants
|
Adverse Events
Cheetah® Non-invasive Cardiac Monitoring System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place