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

NCT07430254 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-84875
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia, Severe; Pregnancy

Keywords

Fluid responsiveness

Outcome Measures

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)

  Baseline (semi-recumbent) and 1 minute after passive leg raising

Secondary Outcomes (7)

• Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness

  Baseline (semi-recumbent) and 1 minute after passive leg raising

• Prediction Accuracy for Change in Stroke Volume for Fluid Responsiveness

  Baseline (semi-recumbent) and 1 minute after passive leg raising

• Prediction accuracy for Pulsatility Index at Baseline

  Baseline (semi-recumbent)

• Prediction accuracy for Stroke Volume at Baseline

  Baseline (semi-recumbent)

• Prediction accuracy for Cardiac Output at Baseline

  Baseline (semi-recumbent)

Study Arms (2)

Healthy pregnant women

Pregnant participants without hypertensive disorders enrolled for brief, noninvasive hemodynamic assessments

Diagnostic Test: Noninvasive finger plethysmographic cardiac output monitoring; Diagnostic Test: Standard transthoracic echocardiographic assessment

Preeclampsia With Severe Features

Women diagnosed with preeclampsia with severe features enrolled for brief, noninvasive hemodynamic assessments

Diagnostic Test: Noninvasive finger plethysmographic cardiac output monitoring; Diagnostic Test: Standard transthoracic echocardiographic assessment

Interventions

Noninvasive finger plethysmographic cardiac output monitoring DIAGNOSTIC_TEST

Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness

Healthy pregnant women; Preeclampsia With Severe Features

Standard transthoracic echocardiographic assessment DIAGNOSTIC_TEST

Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness

Healthy pregnant women; Preeclampsia With Severe Features

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Study Team

CONTACT

(650) 723-5403; cortner@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)