Passive Leg Raising in Term Pregnancy on Hemodynamic Monitoring - Validating With Transthoracic E… (NCT07253818) | Clinical Trial Compass
WithdrawnNot Applicable
Passive Leg Raising in Term Pregnancy on Hemodynamic Monitoring - Validating With Transthoracic ECHO (LG-ECHO)
Stopped: The study was withdrawned because of lack of relevant devices in the study center
United States0Started 2026-01-01
Plain-language summary
This prospective observational validation study aims to evaluate the agreement and diagnostic accuracy of ClearSight™ compared with transthoracic echocardiography (TTE) during PLR in term pregnant women.
The ultimate goal is to determine whether ClearSight™ can reliably identify preload responsiveness in term pregnant women compared with the echocardiographic gold standard. The clinical implication is that, if validated, ClearSight™ may reduce unnecessary or harmful fluid administration by accurately detecting preload reserve, and improve maternal safety in peripartum care by providing obstetric anesthesiologists with reliable bedside monitoring tools.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Term pregnant patients
* Singleton pregnancy at ≥37+0 weeks of gestation.
* Maternal age between 18 and 45 years.
* Hemodynamically stable and in sinus rhythm.
* Ability to provide verbal and written informed consent.
Exclusion Criteria:
* Hypertensive disorders of pregnancy, significant valvular or congenital heart disease, cardiomyopathy, or persistent arrhythmias.
* Multiple gestation (i.e., Twin pregnancy and above)
* Endocrine or hematologic conditions likely to affect hemodynamics, including diabetes with or without autonomic neuropathy, thyroid storm, or severe anemia (hemoglobin \<8 g/dL).
* Active labor with pain or current infusion of uterotonic or vasoactive agents.
* Ruptured membranes with frequent contractions or indications for emergent delivery.
* Inadequate transthoracic echocardiographic imaging windows at screening.
* Emergency or STAT (statim) Cesarean Deliveries
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has a status of 'withdrawn,' meaning it never enrolled participants — can you tell me if there's a similar study currently recruiting that looks at hemodynamic monitoring during labor and delivery that might be relevant to my care?
2Since this study was focused on measuring how blood flow changes during pregnancy using a passive leg raising test, is non-invasive hemodynamic monitoring something that might already be used as part of my labor and delivery care, without needing a trial?
3The trial was comparing two monitoring tools — a finger-cuff device called ClearSight™ and an ultrasound of the heart — to see if they agree with each other; is either of these tools something my care team uses or recommends for monitoring my heart function during labor?
4If I have concerns about blood pressure or circulation changes during labor, what monitoring approaches does your team currently use, and are there any active research studies you'd suggest I look into instead of this withdrawn trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR.