Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy pregnant women | Pregnant participants without hypertensive disorders enrolled for brief, noninvasive hemodynamic assessments |
| |
| Preeclampsia With Severe Features | Women diagnosed with preeclampsia with severe features enrolled for brief, noninvasive hemodynamic assessments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive finger plethysmographic cardiac output monitoring | Diagnostic Test | Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (semi-recumbent) and 1 minute after passive leg raising |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (semi-recumbent) and 1 minute after passive leg raising |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | (650) 723-5403 | cortner@stanford.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Palo Alto | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard transthoracic echocardiographic assessment | Diagnostic Test | Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness |
|
| 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) | Baseline (semi-recumbent) and 1 minute after passive leg raising |
| 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) | Baseline (semi-recumbent) |
| 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) | Baseline (semi-recumbent) |
| Prediction accuracy for Cardiac Output at Baseline | Prediction accuracy (ROC-AUC) of baseline cardiac output measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference) | Baseline (semi-recumbent) |
| Optimal Diagnostic Cut-Off and Operating Characteristics for Device Parameters | Determination of optimal cut-off values and corresponding sensitivity, specificity, positive predictive value and negative predictive value for noninvasive finger plethysmographic device (TTE reference) | Baseline (semi-recumbent) and 1 minute after passive leg raising |
| Inter-observer and Intra-observer Variability for Measurements | Inter-observer and intra-observer variability metrics for noninvasive finger plethysmographic device and for TTE. | Baseline (semi-recumbent) and 1 minute after passive leg raising |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided