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Not yet recruiting NCT07430254

Finger Plethysmography to Predict Fluid Responsiveness in Healthy Pregnancy and Severe Preeclampsia

— Observational Pre-Eclampsia, Severe Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Noninvasive finger plethysmographic cardiac output monitoring, Standard transthoracic echocardiographic assessment.
Who it may be relevant to
Registry conditions: Pre-Eclampsia, Severe, Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Finger Plethysmographic Cardiac Output Monitoring to Predict Fluid Responsiveness in Healthy Pregnancy and Women Diagnosed With Preeclampsia and Severe Features

Overview

The goal of this observational study is to determine whether noninvasive finger plethysmographic cardiac output monitoring can help predict fluid responsiveness in pregnant women, including those with preeclampsia with severe features. The main questions it aims to answer are : * Can changes in cardiac output measured by finger plethysmography predict fluid responsiveness? * How does this method perform compared with standard echocardiographic assessment? Participants will provide consent and undergo noninvasive hemodynamic monitoring and a brief reversible physiological challenge.

Interventions

  • Diagnostic test Noninvasive finger plethysmographic cardiac output monitoring
    Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness
  • Diagnostic test Standard transthoracic echocardiographic assessment
    Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness

Primary outcome measures

  • Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness [Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising]
Secondary outcome measures (7)
  • Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness [Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising]
  • Prediction Accuracy for Change in Stroke Volume for Fluid Responsiveness [Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising]
  • Prediction accuracy for Pulsatility Index at Baseline [Time frame: Baseline (semi-recumbent)]
  • Prediction accuracy for Stroke Volume at Baseline [Time frame: Baseline (semi-recumbent)]
  • Prediction accuracy for Cardiac Output at Baseline [Time frame: Baseline (semi-recumbent)]
  • Optimal Diagnostic Cut-Off and Operating Characteristics for Device Parameters [Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising]
  • Inter-observer and Intra-observer Variability for Measurements [Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising]

Eligibility criteria

Inclusion criteria

  • Women diagnosed with preeclampsia with severe features following ACOG recommendations (systolic/diastolic BP >160/110 mmHg, proteinuria, or other severe features like headaches, visual disturbances, kidney/liver impairment, thrombocytopenia).
  • Healthy pregnant women at term (for comparison group, e.g., scheduled for elective Cesarean delivery).

Exclusion criteria

  • Patients who can not provide written consent to participate in the study
  • BMI greater than 40 kg/m²
  • Multiple pregnancy (twins, triplets, etc.)
  • Non-reassuring fetal heart tracing
  • ≤ 22 weeks gestation
  • History of chronic arterial hypertension
  • Chronic kidney disease
  • Congenital or known acquired heart disease
  • Chronic obstructive pulmonary disease
  • Diabetes
  • History of stroke
  • Not tolerating passive leg raising (unable to be placed in the required study position)
  • No TTE-windows
  • Withdrawing consent
  • Emergency cesarean delivery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Lucile Packard Children's Hospital — Palo Alto

Identifiers

NCT: NCT07430254 · IRB-84875

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗