Preeclampsia With Severe Features
Conditions
Keywords
preeclampsia with severe features, magnesium sulfate, Systemic Vascular Resistance, non-invasive cardiac monitoring
Brief summary
This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups: * 24 hours of postpartum magnesium sulfate (current arbitrary standard of care) * Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.
Interventions
DEVICECheetah® 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))
OTHERStandard of care
24 hours of postpartum magnesium sulfate
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Preeclampsia with severe features, diagnosed using the American Congress of Obstetricians and Gynecologists (ACOG) standard criteria 4 requiring magnesium sulfate * Females older than 18 years of age * Singleton pregnancy * Gestational age greater than 24 0/7 weeks * The patient is physically and mentally able to understand the informed consent and is willing to participate in this study * Able to speak English or Spanish
Exclusion criteria
* Multiple gestation * Prisoners * Patients with chronic renal insufficiency or epilepsy * Known cardiovascular disease * Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis) * Patients with eclampsia or HELLP syndrome * Contraindications for magnesium sulfate
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Postpartum Adverse Outcomes | up to 4 weeks after delivery | 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 |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)) | 21 |
| Standard of Care 24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
Standard of care: 24 hours of postpartum magnesium sulfate | 26 |
| Total | 47 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Cheetah® Non-invasive Cardiac Monitoring System |
|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 5.5 | 30.4 years STANDARD_DEVIATION 5.46 | 31 years STANDARD_DEVIATION 5.5 |
| BMI at delivery | 39.1 Kg/m2 STANDARD_DEVIATION 9.9 | 38.3 Kg/m2 STANDARD_DEVIATION 8.9 | 37.3 Kg/m2 STANDARD_DEVIATION 7.7 |
| Gestational age at delivery | 36 weeks | 36 weeks | 36 weeks |
| Nulliparity | 14 Participants | 26 Participants | 12 Participants |
| Race/Ethnicity, Customized Black race | 6 Participants | 10 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic ethnicity | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White race | 20 Participants | 37 Participants | 17 Participants |
| Region of Enrollment United States | 26 participants | 47 participants | 21 participants |
| Sex: Female, Male Female | 26 Participants | 47 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 26 |
| other Total, other adverse events | 0 / 21 | 0 / 26 |
| serious Total, serious adverse events | 0 / 21 | 0 / 26 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cheetah® Non-invasive Cardiac Monitoring System | 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 |
| 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. | 24 hours | Standard Deviation 0 |
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
Time frame: up to 4 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cheetah® Non-invasive Cardiac Monitoring System | Composite of Postpartum Adverse Outcomes | 6 Participants |
| Standard of Care | Composite of Postpartum Adverse Outcomes | 7 Participants |
Secondary
Evaluating Incidence of Need to Restart Magnesium Sulfate
Time frame: up to 1 week postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cheetah® Non-invasive Cardiac Monitoring System | Evaluating Incidence of Need to Restart Magnesium Sulfate | 0 Participants |
| Standard of Care | Evaluating Incidence of Need to Restart Magnesium Sulfate | 0 Participants |
Secondary
Evaluating Number of Participants With Hospital Readmission for Preeclampsia
Time frame: up to 4 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cheetah® Non-invasive Cardiac Monitoring System | Evaluating Number of Participants With Hospital Readmission for Preeclampsia | 0 Participants |
| Standard of Care | Evaluating Number of Participants With Hospital Readmission for Preeclampsia | 1 Participants |
Secondary
Need for More Than 1 Dose of Anti-hypertensive Medication
Time frame: Up to 5 days after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cheetah® Non-invasive Cardiac Monitoring System | Need for More Than 1 Dose of Anti-hypertensive Medication | 4 Participants |
| Standard of Care | Need for More Than 1 Dose of Anti-hypertensive Medication | 3 Participants |
Secondary
Use of Acute Anti-hypertensive Medications
Time frame: Up to 5 days after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cheetah® Non-invasive Cardiac Monitoring System | Use of Acute Anti-hypertensive Medications | 6 Participants |
| Standard of Care | Use of Acute Anti-hypertensive Medications | 7 Participants |