Pre-Eclampsia, SevereNCT07430254
Finger Plethysmography to Predict Fluid Responsiveness in Healthy Pregnancy and Severe Preeclampsia
An observational study of Pre-Eclampsia, Severe and Pregnancy, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Severe, Pregnancy
- What is being tested?
- Noninvasive finger plethysmographic cardiac output monitoring and Standard transthoracic echocardiographic assessment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: 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.
- Conditions
- Pre-Eclampsia, Severe, Pregnancy
- Being tested
- Noninvasive finger plethysmographic cardiac output monitoring, Standard transthoracic echocardiographic assessment
- Keywords
- Fluid responsiveness
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive finger plethysmographic cardiac output monitoringDiagnostic test
Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness
Standard transthoracic echocardiographic assessmentDiagnostic test
Noninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women | Pregnant participants without hypertensive disorders enrolled for brief, noninvasive hemodynamic assessments Receives: 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 Receives: Diagnostic Test: Noninvasive finger plethysmographic cardiac output monitoring; Diagnostic Test: Standard transthoracic echocardiographic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (semi-recumbent) and 1 minute after passive leg raising
Secondary outcomes (7)
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)
Measured: Baseline (semi-recumbent) and 1 minute after passive leg raising
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Baseline (semi-recumbent) and 1 minute after passive leg raising
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Eclampsia, SevereStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Ortner, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430254
- Sponsor's protocol ID
- IRB-84875
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finger Plethysmographic Cardiac Output Monitoring to Predict Fluid Responsiveness in Healthy Pregnancy and Women Diagnosed With Preeclampsia and Severe Features
- ClinicalTrials.gov ID
- NCT07430254
- Acronym / sponsor ID
- IRB-84875
- Conditions
- Pre-Eclampsia, Severe, Pregnancy
- Keywords
- Fluid responsiveness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | – | Diagnostic Test: Noninvasive finger plethysmographic cardiac output monitoring, Diagnostic Test: Standard transthoracic echocardiographic assessmentPregnant participants without hypertensive disorders enrolled for brief, noninvasive hemodynamic assessments |
| Preeclampsia With Severe Features | – | Diagnostic Test: Noninvasive finger plethysmographic cardiac output monitoring, Diagnostic Test: Standard transthoracic echocardiographic assessmentWomen diagnosed with preeclampsia with severe features enrolled for brief, noninvasive hemodynamic assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive finger plethysmographic cardiac output monitoringNoninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness | Diagnostic test | Healthy pregnant women, Preeclampsia With Severe Features |
| Standard transthoracic echocardiographic assessmentNoninvasive hemodynamic monitoring (echocardiography) used to assess changes in cardiac output for prediction of fluid responsiveness | Diagnostic test | Healthy pregnant women, Preeclampsia With Severe Features |
Primary outcome
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)
7 secondary outcomes
Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness
Time frame: 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 for Pulsatility Index at Baseline
Time frame: Baseline (semi-recumbent)
Prediction accuracy for Stroke Volume at Baseline
Time frame: Baseline (semi-recumbent)
Prediction accuracy for Cardiac Output at Baseline
Time frame: 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
Inter-observer and Intra-observer Variability for Measurements
Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, Severe and Pregnancy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Team ((650) 723-5403, cortner@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness (time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.