[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07430254":3,"trial-entities:NCT07430254":114,"trial-summary:NCT07430254":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":68,"minimum_age":69,"maximum_age":17,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":92,"locations":95,"central_contacts":105,"overall_officials":111,"references":112,"see_also_links":113},"NCT07430254","IRB-84875","Finger Plethysmography to Predict Fluid Responsiveness in Healthy Pregnancy and Severe Preeclampsia","Finger Plethysmographic Cardiac Output Monitoring to Predict Fluid Responsiveness in Healthy Pregnancy and Women Diagnosed With Preeclampsia and Severe Features","NOT_YET_RECRUITING","2028-07-01","2026-02","2026-02-24","2026-07-01","Stanford University","OTHER",false,"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.\n\nThe main questions it aims to answer are :\n\n* Can changes in cardiac output measured by finger plethysmography predict fluid responsiveness?\n* 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.",null,[19,20],"Pre-Eclampsia, Severe","Pregnancy",[22],"Fluid responsiveness","OBSERVATIONAL",[],{"count":26,"type":27},88,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIAGNOSTIC_TEST","Noninvasive finger plethysmographic cardiac output monitoring","Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness",[34,35],"Healthy pregnant women","Preeclampsia With Severe Features",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Standard transthoracic echocardiographic assessment","Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness",[34,35],[41],{"measure":42,"description":43,"timeFrame":44},"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",[46,49,52,56,59,62,65],{"measure":47,"description":48,"timeFrame":44},"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)",{"measure":50,"description":51,"timeFrame":44},"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)",{"measure":53,"description":54,"timeFrame":55},"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)",{"measure":57,"description":58,"timeFrame":55},"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)",{"measure":60,"description":61,"timeFrame":55},"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)",{"measure":63,"description":64,"timeFrame":44},"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)",{"measure":66,"description":67,"timeFrame":44},"Inter-observer and Intra-observer Variability for Measurements","Inter-observer and intra-observer variability metrics for noninvasive finger plethysmographic device and for TTE.","FEMALE","18 Years",true,{"inclusion":72,"exclusion":75,"raw_text":91},[73,74],"Women diagnosed with preeclampsia with severe features following ACOG recommendations (systolic\u002Fdiastolic BP \\>160\u002F110 mmHg, proteinuria, or other severe features like headaches, visual disturbances, kidney\u002Fliver impairment, thrombocytopenia).","Healthy pregnant women at term (for comparison group, e.g., scheduled for elective Cesarean delivery).",[76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"Patients who can not provide written consent to participate in the study","BMI greater than 40 kg\u002Fm²","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","Inclusion Criteria:\n\n* Women diagnosed with preeclampsia with severe features following ACOG recommendations (systolic\u002Fdiastolic BP \\>160\u002F110 mmHg, proteinuria, or other severe features like headaches, visual disturbances, kidney\u002Fliver impairment, thrombocytopenia).\n* Healthy pregnant women at term (for comparison group, e.g., scheduled for elective Cesarean delivery).\n\nExclusion Criteria:\n\n* Patients who can not provide written consent to participate in the study\n* BMI greater than 40 kg\u002Fm²\n* Multiple pregnancy (twins, triplets, etc.)\n* Non-reassuring fetal heart tracing\n* ≤ 22 weeks gestation\n* History of chronic arterial hypertension\n* Chronic kidney disease\n* Congenital or known acquired heart disease\n* Chronic obstructive pulmonary disease\n* Diabetes\n* History of stroke\n* Not tolerating passive leg raising (unable to be placed in the required study position)\n* No TTE-windows\n* Withdrawing consent\n* Emergency cesarean delivery",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":97,"city":98,"state":99,"zip":100,"country":101,"geoPoint":102},"Lucile Packard Children's Hospital","Palo Alto","California","94304","United States",{"lat":103,"lon":104},37.44188,-122.14302,[106],{"name":107,"role":108,"phone":109,"email":110},"Study Team","CONTACT","(650) 723-5403","cortner@stanford.edu",[],[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116,20],"Preeclampsia",[],{"nct_id":4,"found":70,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an observational study, meaning researchers will watch and record information without giving a specific treatment. It plans to include 88 participants.","completed","Finger Plethysmography for Fluid Responsiveness in Pregnancy","This observational study is looking at a noninvasive (no needles or surgery) way to predict how a pregnant woman's body will respond to fluids. Researchers are comparing two methods: noninvasive finger plethysmographic cardiac output monitoring and standard transthoracic echocardiographic assessment (an ultrasound of the heart). The goal is to see if finger plethysmography can accurately predict changes in cardiac output (how much blood your heart pumps) when a woman's legs are raised, which helps doctors understand fluid responsiveness. This study includes healthy pregnant women and those with severe preeclampsia (high blood pressure and other issues during pregnancy). The study aims to enroll 88 women.","Researchers will measure changes at baseline (when you're semi-reclined) and 1 minute after your legs are raised.",104,"You would provide consent, undergo noninvasive heart monitoring, and participate in a brief, reversible physical challenge (like raising your legs).","Not stated in the trial record.",[31,37],"v2"]