Pre-Eclampsia, Severe, Pregnancy
Conditions
Keywords
Fluid responsiveness
Brief summary
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_TESTNoninvasive finger plethysmographic cardiac output monitoring
Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness
DIAGNOSTIC_TESTStandard transthoracic echocardiographic assessment
Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness | Baseline (semi-recumbent) and 1 minute after passive leg raising | Prediction accuracy (ROC-AUC) of percent change in cardiac output measured by noninvasive finger plethysmographic device during passive leg raising to identify fluid responsiveness (TTE reference) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness | Baseline (semi-recumbent) and 1 minute after passive leg raising | Prediction accuracy (ROC-AUC) of percent change in pulsatility index measured by noninvasive finger plethysmographic device during passive leg raising to identify fluid responsiveness (TTE reference) |
| Prediction Accuracy for Change in Stroke Volume for Fluid Responsiveness | Baseline (semi-recumbent) and 1 minute after passive leg raising | Prediction accuracy (ROC-AUC) of percent change in stroke volume measured by noninvasive finger plethysmographic device during passive leg raising to identify fluid responsiveness (TTE reference) |
| Prediction accuracy for Pulsatility Index at Baseline | Baseline (semi-recumbent) | Prediction accuracy (ROC-AUC) of baseline pulsatility index measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference) |
| Prediction accuracy for Stroke Volume at Baseline | Baseline (semi-recumbent) | Prediction accuracy (ROC-AUC) of baseline stroke volume measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference) |
| Prediction accuracy for Cardiac Output at Baseline | Baseline (semi-recumbent) | Prediction accuracy (ROC-AUC) of baseline cardiac output measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference) |
| Optimal Diagnostic Cut-Off and Operating Characteristics for Device Parameters | Baseline (semi-recumbent) and 1 minute after passive leg raising | Determination of optimal cut-off values and corresponding sensitivity, specificity, positive predictive value and negative predictive value for noninvasive finger plethysmographic device (TTE reference) |
| Inter-observer and Intra-observer Variability for Measurements | Baseline (semi-recumbent) and 1 minute after passive leg raising | Inter-observer and intra-observer variability metrics for noninvasive finger plethysmographic device and for TTE. |
Countries
United States
Contacts
CONTACTStudy Team
Outcome results
None listed