Pre-Eclampsia
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTEchocardiogrpahy and non-invasive monitoring
Study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff.
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia |
| Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsia |
| Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia |
| Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsiaanalysis) monitoring |
| Change in Cardiac output (L/min) as measured by transthoracic echocardiography | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia |
| Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography | Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum) | Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsia |
Countries
United States
Outcome results
None listed