Finger Plethysmography to Predict Fluid Responsiveness in Healthy Pregnancy and Severe Preeclampsia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial population
The study will recruit pregnant people presenting to participating hospital. Two cohorts will be enrolled: healthy pregnant volunteers at term (without hypertensive disorders) and women with a clinical diagnosis of pre-eclampsia with severe features.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Noninvasive finger plethysmographic cardiac output monitoring
Diagnostic testNoninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness
Standard transthoracic echocardiographic assessment
Diagnostic testNoninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Healthy pregnant women2 interventions
Group B: Preeclampsia With Severe Features2 interventions
Trial outcomes
Primary outcomes
1
Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness
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)
Time frame
Baseline (semi-recumbent) and 1 minute after passive leg raisingSecondary outcomes
1
Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness
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)
Time frame
Baseline (semi-recumbent) and 1 minute after passive leg raising2
Prediction Accuracy for Change in Stroke Volume for Fluid Responsiveness
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)
Time frame
Baseline (semi-recumbent) and 1 minute after passive leg raising3
Prediction accuracy for Pulsatility Index at Baseline
Prediction accuracy (ROC-AUC) of baseline pulsatility index measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference)
Time frame
Baseline (semi-recumbent)4
Prediction accuracy for Stroke Volume at Baseline
Prediction accuracy (ROC-AUC) of baseline stroke volume measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference)
Time frame
Baseline (semi-recumbent)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: