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

February 18, 2026 updated by: Clemens Ortner, Stanford University

Finger Plethysmographic Cardiac Output Monitoring to Predict Fluid Responsiveness in Healthy Pregnancy and Women Diagnosed With Preeclampsia and Severe Features

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy pregnant women
Pregnant participants without hypertensive disorders enrolled for brief, noninvasive hemodynamic assessments
Diagnostic test: Noninvasive finger plethysmographic cardiac output monitoring
Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness
Diagnostic test: Standard transthoracic echocardiographic assessment
Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness
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
Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness
Diagnostic test: Standard transthoracic echocardiographic assessment
Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness
Time Frame: 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)
Baseline (semi-recumbent) and 1 minute after passive leg raising

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness
Time Frame: 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)
Baseline (semi-recumbent) and 1 minute after passive leg raising
Prediction Accuracy for Change in Stroke Volume for Fluid Responsiveness
Time Frame: 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)
Baseline (semi-recumbent) and 1 minute after passive leg raising
Prediction accuracy for Pulsatility Index at Baseline
Time Frame: Baseline (semi-recumbent)
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
Time Frame: Baseline (semi-recumbent)
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
Time Frame: Baseline (semi-recumbent)
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
Time Frame: 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)
Baseline (semi-recumbent) and 1 minute after passive leg raising
Inter-observer and Intra-observer Variability for Measurements
Time Frame: 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.
Baseline (semi-recumbent) and 1 minute after passive leg raising

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-84875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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