Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements

Study Overview
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Brief Summary
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The purpose of this study is to compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (NICOM; Cheetah Medical) and pulse wave analysis as assessed by finger cuff arterial pressure (ClearSite, Edwards Life Sciences) - compared to hemodynamic assessments by intermittent echocardiography in early onset preeclampsia.

Official Title
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Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Diagnostic Test: Echocardiogrpahy and non-invasive monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BP >160 or DBP >110 gestational age between 20-34 weeks singleton pregnancy Exclusion Criteria: prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy multi-fetal pregnancy

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart and vascular function<br>All study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff to determine the best method of monitoring heart and vascular function in preeclampsia. | Diagnostic Test: Echocardiogrpahy and non-invasive monitoring<br>* Study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring | Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | 
| Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring | Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsia | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | 
| Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring | Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | 
| Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring | Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsiaanalysis) monitoring | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | 
| Change in Cardiac output (L/min) as measured by transthoracic echocardiography | Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | 
| Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography | Systemic vascular resistance ranges 600-2000 dynes/sec*cm-5, higher values associated with more severe preeclampsia | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) |