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

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Diagnostic test: Echocardiogrpahy and non-invasive monitoring

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with severe preeclampsia.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart and vascular function; 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; Study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 2000028142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes