Maternity(LG-ECHO)NCT07253818

Passive Leg Raising in Term Pregnancy on Hemodynamic Monitoring - Validating With Transthoracic ECHO (LG-ECHO)

An observational study of Maternity and Pregnancy, run by Ayse Zeynep Turan Civraz at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Maternity, Pregnancy, Labor and Delivery
What is being tested?: ClearSight™ System, Transthoracic Echocardiography and Passive Leg Raising (PLR) Maneuver
Type of treatment: Medical device, Surgery or procedure
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2026to 30 Jul 2026
How long will I take part?: 1 Day
Phase: Observational
Are there results?: None posted in the registry

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 to 45 years
Women only
Healthy volunteers accepted
Adult

Study population: Patients will be enrolled when they come to the OB clinic for evaluation and the consents will be obtained. Patients are instructed during consent to abstain from caffeine/nicotine (≥4h) and heavy meals (≥6h). This is feasible as women are already required to fast preoperatively.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UF Health Jacksonville (Shands Hospital)
Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: Transthoracic Echocardiography as the Reference for Validating Non-invasive Hemodynamic Monitoring During Passive Leg Raising in Term Pregnancy

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.

Read the detailed description

Background Pregnancy is characterized by profound hemodynamic changes, which complicate perioperative monitoring and fluid therapy. Non-invasive cardiac output monitoring device, ClearSight™ system, provides continuous stroke volume estimates, but their reliability in pregnant women remains uncertain. Passive leg raising (PLR) is a reversible preload test that can elucidate fluid responsiveness without fluid administration. To date, no study has simultaneously validated ClearSight™ against echocardiographic reference standards during PLR in term pregnant women.

Methods This is a prospective, single-centre, method-comparison and diagnostic accuracy study in term pregnant women (≥37 weeks). Simultaneous ClearSight™ and transthoracic echocardiography (TTE) measurements will be obtained at baseline, during PLR, and during recovery. The primary outcome is agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR. Secondary outcomes include trending ability and diagnostic accuracy of ClearSight™ Δ%SVI for detecting PLR responders. Four-quadrant and polar plot analyses are the parameters for advanced hemodynamic monitoring methods used in echocardiography to assess fluid responsiveness and cardiac output (CO) trending Sample size: 60 participants, providing at least 180 paired observations.

Conclusions This study will establish whether ClearSight™ can reliably detect preload responsiveness in term pregnant women. Findings could support safer, real-time, non-invasive hemodynamic management during obstetric anaesthesia and maternal critical care.

Conditions: Maternity, Pregnancy, Labor and Delivery, Hemodynamic Changes
Being tested: ClearSight™ System, Transthoracic Echocardiography, Passive Leg Raising (PLR) Maneuver
Keywords: hemodynamic changes, pregnancy, clearsight, transthoracic echocardiography, Passive Leg Raising Maneuver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClearSight™ SystemDevice
ClearSight™ is FDA 510(k) cleared for non-invasive measurement of blood pressure and derived hemodynamic parameters in adults (≥18 years) and pediatric patients ≥12 years when used with EV1000 or HemoSphere Baseline, during passive leg raising (PLR) and after PLR measurements will be acquired. Data will be continuously recorded for 5 minutes at 60-second intervals using a dedicated monitor (EV1000™).
Transthoracic EchocardiographyDevice
This study uses transthoracic echocardiography (TTE), which is a non-invasive imaging modality All measurements will be obtained with participants in the 15° left tilt position in order to minimize inferior vena cava compression from the gravid uterus and to avoid haemodynamic fluctuations associated with positional changes Initially, the left ventricular outflow tract (LVOT) diameter will be obtained at end-expiration in the parasternal long-axis view, measured from the inner edge to inner edge of the aortic annulus. Subsequently, the LVOT velocity-time integral (LVOT-VTI) will be assessed using pulsed-wave Doppler, with the sampling volume positioned at the centre of the LVOT in the apical five-chamber view. LVOT diameter will be measured from the parasternal long-axis view (inner-edge to inner-edge, mid-systole), with the average of two measurements recorded.
Measurements will be recorded at three timepoints: baseline at the end of PLR, after PLR
Passive Leg Raising (PLR) ManeuverProcedure or surgery
This manoeuvre acts as a rapid, transient, and reversible "auto-fluid challenge" by mobilizing blood from the venous reservoir of the lower extremities into the central circulation. The resulting temporary increase in preload can augment cardiac output in preload-responsive patients through the Frank-Starling mechanism .
An electronically adjustable bed, capable of altering position without requiring active movement from the participant, will be utilized in the study. Baseline hemodynamic recordings will be taken following 5 minutes of rest in supine position with 15° left tilt, and the head of the bed elevated to 45°. Subsequently, the head section of the bed will be swiftly returned to a flat position, while the leg section will be elevated to 45°, thereby achieving passive leg raising. Hemodynamic variables will be measured around 90 seconds after PLR will be compared with baseline values.

What is being measured

The primary outcome is the main question the study is designed to answer.

Agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR.
The primary outcome is agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR.
Measured: During PLR

Secondary outcomes (1)

Trending ability and diagnostic accuracy of ClearSight™ Δ%SVI for detecting PLR responders
Trending ability and diagnostic accuracy of ClearSight™ Δ%SVI for detecting PLR responders
Measured: During PLR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202630 Jul 2026

First posted28 Nov 2025
Study start1 Jan 2026 (estimated)
Primary completion30 May 2026 (estimated)
Study completion30 Jul 2026 (estimated)

Why it stopped: The study was withdrawned because of lack of relevant devices in the study center

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for MaternityStudies of the same condition, open and under way.
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: 0 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT07253818
Sponsor's protocol ID: AS-01-OBS
Acronym: (LG-ECHO)
Status last verified: Jan 2026
First submitted: 19 Nov 2025
Last updated: 29 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Vartun A, Flo K, Acharya G. Effect of passive leg raising on systemic hemodynamics of pregnant women: a dynamic assessment of maternal cardiovascular function at 22-24 weeks of gestation. PLoS One. 2014 Apr 14;9(4):e94629. doi: 10.1371/journal.pone.0094629. eCollection 2014.
PubMed 24732308
Quinones MA, Otto CM, Stoddard M, Waggoner A, Zoghbi WA; Doppler Quantification Task Force of the Nomenclature and Standards Committee of the American Society of Echocardiography. Recommendations for quantification of Doppler echocardiography: a report from the Doppler Quantification Task Force of the Nomenclature and Standards Committee of the American Society of Echocardiography. J Am Soc Echocardiogr. 2002 Feb;15(2):167-84. doi: 10.1067/mje.2002.120202. No abstract available.
PubMed 11836492
Duclos G, Granier S, Hili A, Blanc J, Einav S, Leone M, Zieleskiewicz L. Performance of non-invasive stroke volume variation during passive leg raising as a predictor of hypotension following induction of spinal anesthesia for elective cesarean delivery: a single cohort study. Int J Obstet Anesth. 2022 May;50:103251. doi: 10.1016/j.ijoa.2021.103251. Epub 2021 Dec 30.
PubMed 35074676
Duclos G, Hili A, Resseguier N, Kelway C, Haddam M, Bourgoin A, Carcopino X, Zieleskiewicz L, Leone M. Clearsight use for haemodynamic monitoring during the third trimester of pregnancy - a validation study. Int J Obstet Anesth. 2018 Nov;36:85-95. doi: 10.1016/j.ijoa.2018.04.009. Epub 2018 May 8.
PubMed 30392653
Marques NR, Martinello C, Kramer GC, Costantine MM, Vadhera RB, Saade GR, Hankins GD, Pacheco LD. Passive leg raising during pregnancy. Am J Perinatol. 2015 Mar;32(4):393-8. doi: 10.1055/s-0034-1389089. Epub 2014 Sep 21.
PubMed 25241109
Herrera S, Kuhlmann-Capek MJ, Rogan SC, Saad AF, Saade GR, Hankins GDV, Pacheco LD. Stroke Volume Recruitability during the Third Trimester of Pregnancy. Am J Perinatol. 2018 Jul;35(8):737-740. doi: 10.1055/s-0037-1615788. Epub 2017 Dec 26.
PubMed 29278864
Vartun A, Flo K, Wilsgaard T, Acharya G. Maternal functional hemodynamics in the second half of pregnancy: a longitudinal study. PLoS One. 2015 Aug 10;10(8):e0135300. doi: 10.1371/journal.pone.0135300. eCollection 2015.
PubMed 26258418
Monnet X, Teboul JL. Prediction of fluid responsiveness in spontaneously breathing patients. Ann Transl Med. 2020 Jun;8(12):790. doi: 10.21037/atm-2020-hdm-18.
PubMed 32647715
Helmer P, Helf D, Sammeth M, Winkler B, Hottenrott S, Meybohm P, Kranke P. The Use of Non-Invasive Continuous Blood Pressure Measuring (ClearSight(R)) during Central Neuraxial Anaesthesia for Caesarean Section-A Retrospective Validation Study. J Clin Med. 2022 Aug 2;11(15):4498. doi: 10.3390/jcm11154498.
PubMed 35956113
Akkermans J, Diepeveen M, Ganzevoort W, van Montfrans GA, Westerhof BE, Wolf H. Continuous non-invasive blood pressure monitoring, a validation study of Nexfin in a pregnant population. Hypertens Pregnancy. 2009 May;28(2):230-42. doi: 10.1080/10641950802601260.
PubMed 19437233
Lihme F, Basit S, Persson LG, Larsen MO, Lauridsen KH, Lykke JA, Andersen AS, Halse K, Thorsen-Meyer A, Melbye M, Wohlfahrt J, Boyd HA. Reference ranges for third-trimester maternal cardiovascular function parameters measured in normotensive pregnant women using a non-invasive cardiac output monitor: A study based on data from the prospective PEACH cohort study. BJOG. 2024 Mar;131(4):463-471. doi: 10.1111/1471-0528.17667. Epub 2023 Sep 21.
PubMed 37735094
McLaughlin K, Wright SP, Kingdom JCP, Parker JD. Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women. J Obstet Gynaecol Can. 2017 Nov;39(11):1008-1014. doi: 10.1016/j.jogc.2017.02.015. Epub 2017 Jul 18.
PubMed 28733057
Ling HZ, Gallardo-Arozena M, Company-Calabuig AM, Nicolaides KH, Kametas NA. Clinical validation of bioreactance for the measurement of cardiac output in pregnancy. Anaesthesia. 2020 Oct;75(10):1307-1313. doi: 10.1111/anae.15110. Epub 2020 May 29.
PubMed 32469423
Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
PubMed 29090733
Cornette J, Laker S, Jeffery B, Lombaard H, Alberts A, Rizopoulos D, Roos-Hesselink JW, Pattinson RC. Validation of maternal cardiac output assessed by transthoracic echocardiography against pulmonary artery catheterization in severely ill pregnant women: prospective comparative study and systematic review. Ultrasound Obstet Gynecol. 2017 Jan;49(1):25-31. doi: 10.1002/uog.16015. Epub 2016 Nov 28.
PubMed 27404397

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Maternity trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transthoracic Echocardiography as the Reference for Validating Non-invasive Hemodynamic Monitoring During Passive Leg Raising in Term Pregnancy
ClinicalTrials.gov ID: NCT07253818
Acronym / sponsor ID: (LG-ECHO) / AS-01-OBS
Conditions: Maternity, Pregnancy, Labor and Delivery, Hemodynamic Changes
Keywords: hemodynamic changes, pregnancy, clearsight, transthoracic echocardiography, Passive Leg Raising Maneuver
Study type: Observational
Recruitment status: WithdrawnReason stopped: The study was withdrawned because of lack of relevant devices in the study center
Enrolment: 0 participants (actual)
Lead sponsor: Ayse Zeynep Turan CivrazOther government
Study start: 1 Jan 2026 (estimated)
Primary completion: 30 May 2026 (estimated)
Study completion: 30 Jul 2026 (estimated)
First posted: 28 Nov 2025 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Day

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Patients will be enrolled when they come to the OB clinic for evaluation and the consents will be obtained. Patients are instructed during consent to abstain from caffeine/nicotine (≥4h) and heavy meals (≥6h). This is feasible as women are already required to fast preoperatively.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

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
ClearSight™ SystemClearSight™ is FDA 510(k) cleared for non-invasive measurement of blood pressure and derived hemodynamic parameters in adults (≥18 years) and pediatric patients ≥12 years when used with EV1000 or HemoSphere Baseline, during passive leg raising (PLR) and after PLR measurements will be acquired. Data will be continuously recorded for 5 minutes at 60-second intervals using a dedicated monitor (EV1000™).	Device	–
Transthoracic EchocardiographyThis study uses transthoracic echocardiography (TTE), which is a non-invasive imaging modality All measurements will be obtained with participants in the 15° left tilt position in order to minimize inferior vena cava compression from the gravid uterus and to avoid haemodynamic fluctuations associated with positional changes Initially, the left ventricular outflow tract (LVOT) diameter will be obtained at end-expiration in the parasternal long-axis view, measured from the inner edge to inner edge of the aortic annulus. Subsequently, the LVOT velocity-time integral (LVOT-VTI) will be assessed using pulsed-wave Doppler, with the sampling volume positioned at the centre of the LVOT in the apical five-chamber view. LVOT diameter will be measured from the parasternal long-axis view (inner-edge to inner-edge, mid-systole), with the average of two measurements recorded. Measurements will be recorded at three timepoints: baseline at the end of PLR, after PLR	Device	–
Passive Leg Raising (PLR) ManeuverThis manoeuvre acts as a rapid, transient, and reversible "auto-fluid challenge" by mobilizing blood from the venous reservoir of the lower extremities into the central circulation. The resulting temporary increase in preload can augment cardiac output in preload-responsive patients through the Frank-Starling mechanism . An electronically adjustable bed, capable of altering position without requiring active movement from the participant, will be utilized in the study. Baseline hemodynamic recordings will be taken following 5 minutes of rest in supine position with 15° left tilt, and the head of the bed elevated to 45°. Subsequently, the head section of the bed will be swiftly returned to a flat position, while the leg section will be elevated to 45°, thereby achieving passive leg raising. Hemodynamic variables will be measured around 90 seconds after PLR will be compared with baseline values.	Procedure or surgery	–

Primary outcome

Agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR.
Time frame: During PLR
The primary outcome is agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR.

1 secondary outcome

Trending ability and diagnostic accuracy of ClearSight™ Δ%SVI for detecting PLR responders
Time frame: During PLR

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
Background: PubMed 24732308Vartun A, Flo K, Acharya G. Effect of passive leg raising on systemic hemodynamics of pregnant women: a dynamic assessment of maternal cardiovascular function at 22-24 weeks of gestation. PLoS One. 2014 Apr 14;9(4):e94629. doi: 10.1371/journal.pone.0094629. eCollection 2014.
Background: PubMed 11836492Quinones MA, Otto CM, Stoddard M, Waggoner A, Zoghbi WA; Doppler Quantification Task Force of the Nomenclature and Standards Committee of the American Society of Echocardiography. Recommendations for quantification of Doppler echocardiography: a report from the Doppler Quantification Task Force of the Nomenclature and Standards Committee of the American Society of Echocardiography. J Am Soc Echocardiogr. 2002 Feb;15(2):167-84. doi: 10.1067/mje.2002.120202. No abstract available.
Background: PubMed 35074676Duclos G, Granier S, Hili A, Blanc J, Einav S, Leone M, Zieleskiewicz L. Performance of non-invasive stroke volume variation during passive leg raising as a predictor of hypotension following induction of spinal anesthesia for elective cesarean delivery: a single cohort study. Int J Obstet Anesth. 2022 May;50:103251. doi: 10.1016/j.ijoa.2021.103251. Epub 2021 Dec 30.
Background: PubMed 30392653Duclos G, Hili A, Resseguier N, Kelway C, Haddam M, Bourgoin A, Carcopino X, Zieleskiewicz L, Leone M. Clearsight use for haemodynamic monitoring during the third trimester of pregnancy - a validation study. Int J Obstet Anesth. 2018 Nov;36:85-95. doi: 10.1016/j.ijoa.2018.04.009. Epub 2018 May 8.
Background: PubMed 25241109Marques NR, Martinello C, Kramer GC, Costantine MM, Vadhera RB, Saade GR, Hankins GD, Pacheco LD. Passive leg raising during pregnancy. Am J Perinatol. 2015 Mar;32(4):393-8. doi: 10.1055/s-0034-1389089. Epub 2014 Sep 21.
Background: PubMed 29278864Herrera S, Kuhlmann-Capek MJ, Rogan SC, Saad AF, Saade GR, Hankins GDV, Pacheco LD. Stroke Volume Recruitability during the Third Trimester of Pregnancy. Am J Perinatol. 2018 Jul;35(8):737-740. doi: 10.1055/s-0037-1615788. Epub 2017 Dec 26.
Background: PubMed 26258418Vartun A, Flo K, Wilsgaard T, Acharya G. Maternal functional hemodynamics in the second half of pregnancy: a longitudinal study. PLoS One. 2015 Aug 10;10(8):e0135300. doi: 10.1371/journal.pone.0135300. eCollection 2015.
Background: PubMed 32647715Monnet X, Teboul JL. Prediction of fluid responsiveness in spontaneously breathing patients. Ann Transl Med. 2020 Jun;8(12):790. doi: 10.21037/atm-2020-hdm-18.
Background: PubMed 35956113Helmer P, Helf D, Sammeth M, Winkler B, Hottenrott S, Meybohm P, Kranke P. The Use of Non-Invasive Continuous Blood Pressure Measuring (ClearSight(R)) during Central Neuraxial Anaesthesia for Caesarean Section-A Retrospective Validation Study. J Clin Med. 2022 Aug 2;11(15):4498. doi: 10.3390/jcm11154498.
Background: PubMed 19437233Akkermans J, Diepeveen M, Ganzevoort W, van Montfrans GA, Westerhof BE, Wolf H. Continuous non-invasive blood pressure monitoring, a validation study of Nexfin in a pregnant population. Hypertens Pregnancy. 2009 May;28(2):230-42. doi: 10.1080/10641950802601260.
Background: PubMed 37735094Lihme F, Basit S, Persson LG, Larsen MO, Lauridsen KH, Lykke JA, Andersen AS, Halse K, Thorsen-Meyer A, Melbye M, Wohlfahrt J, Boyd HA. Reference ranges for third-trimester maternal cardiovascular function parameters measured in normotensive pregnant women using a non-invasive cardiac output monitor: A study based on data from the prospective PEACH cohort study. BJOG. 2024 Mar;131(4):463-471. doi: 10.1111/1471-0528.17667. Epub 2023 Sep 21.
Background: PubMed 28733057McLaughlin K, Wright SP, Kingdom JCP, Parker JD. Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women. J Obstet Gynaecol Can. 2017 Nov;39(11):1008-1014. doi: 10.1016/j.jogc.2017.02.015. Epub 2017 Jul 18.
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. This study is not recruiting at the moment.

Ayten Saracoglu, Prof. MD principal investigator

University of Florida

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 Maternity and Pregnancy, run by Ayse Zeynep Turan Civraz 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 29 Jan 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR. (time frame: During PLR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07253818, which also lists 16 linked publications.

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 29 Jan 2026.