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Completed

NCT Number: NCT05299229

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Yale University Hospital

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiogrpahy and non-invasive monitoring

Diagnostic Test

Study participants will have echocardiography and non-invasive monitoring by chest/back sensors and a finger cuff.

Primary outcomes

  1. Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring

    Time frame: 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

  2. Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring

    Time frame: 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

  3. Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring

    Time frame: 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

  4. Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring

    Time frame: 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

  5. Change in Cardiac output (L/min) as measured by transthoracic echocardiography

    Time frame: 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

  6. Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 28, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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