Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia

Study Overview
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Brief Summary
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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: 24 hours of postpartum magnesium sulfate (current arbitrary standard of care) Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.

Official Title
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Use of Cheetah® Non-invasive Cardiac Monitoring System to Guide Discontinuation of Postpartum Magnesium Sulfate in Women With Severe Preeclampsia: A Pilot Randomized Control Trial

Conditions
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Preeclampsia With Severe Features

Intervention / Treatment
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* Device: Cheetah® non-invasive cardiac monitoring system
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cheetah® non-invasive cardiac monitoring system<br>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<br>* 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))<br>|
| Other: Standard of care<br>24 hours of postpartum magnesium sulfate (current arbitrary standard of care) | Other: Standard of care<br>* 24 hours of postpartum magnesium sulfate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia with severe features, magnesium sulfate, Systemic Vascular Resistance, non-invasive cardiac monitoring