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NCT Number: NCT07430254

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

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.

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Key information

Conditions

Pre-Eclampsia, Severe Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive finger plethysmographic cardiac output monitoring

Diagnostic Test

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

Standard transthoracic echocardiographic assessment

Diagnostic Test

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team

CONTACT

[email protected]

(650) 723-5403

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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