Obstetric Anesthesia, Cardiac MonitoringLUDCONCT02283931
Cardiac Output Changes With Uterine Displacement
A study testing TTE / NICOM in people with Obstetric Anesthesia, Cardiac Monitoring, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
There is currently little information regarding the hemodynamic differences in uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anesthesia, Cardiac Monitoring
- What is being tested?
- TTE / NICOM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 30 Dec 2027
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy ASA physical status I-II
- Term parturient
Who cannot join
- Woman in labor
- Presence of maternal medical conditions affecting the cardiovascular system (including preeclampsia, gestational hypertension)
- Fetal anomaly or intrauterine growth restriction (< 25th percentile)
- Maternal renal or endocrine disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Assessement of Hemodynamic Changes Associated With Uterine Displacement Using Noninvasive Cardiac Output Monitoring and Transthoracic Echocardiography:
There is currently little information regarding the hemodynamic differences in uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine.
Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are becoming popular techniques in anesthesiology because they can provide noninvasive, valid, and precise hemodynamic data.There has been no study specifically examining the hemodynamic differences between the uterine displacement techniques using NICOM or TTE. While all three uterine displacement techniques are recommended, whether one technique may maximize maternal cardiac output is currently unknown.
Read the detailed description
Aortocaval compression is a well-recognized physiologic concern in pregnancy. The gravid uterus can compress the inferior vena cava, impeding venous return and thereby reducing stroke volume and cardiac output.
The 2014 Society for Obstetric Anesthesia and Perinatology consensus statement on the management of cardiac arrest in pregnancy, and the 2010 American Heart Association guideline on maternal cardiac arrest recommend relieving aortocaval compression during chest compressions by performing uterine displacement There is currently little information regarding the hemodynamic differences amongst the recommended uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine.
Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are becoming popular techniques in anesthesiology because they can provide noninvasive, valid, and precise hemodynamic data.There has been no study specifically examining the hemodynamic differences between the uterine displacement techniques using NICOM or TTE. While all three uterine displacement techniques are recommended, whether one technique may maximize maternal cardiac output is currently unknown.
- Conditions
- Obstetric Anesthesia, Cardiac Monitoring
- Being tested
- TTE / NICOM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTE / NICOMDevice
Also called Transthoracic Echocardiography / Noninvasive Cardiac Output Monitor
| Study group | Role | What they receive |
|---|---|---|
| One handed uterine displacement | Active comparator | Uterine displacement using one hand Receives: Device: TTE / NICOM |
| two handed uterine displacement | Active comparator | Uterine displacement using two hands Receives: Device: TTE / NICOM |
| 30 degrees uterine displacement | Active comparator | Uterine displacement using a 30 degrees wedge Receives: Device: TTE / NICOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study start1 Jan 2015
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: Awaiting New CoInvestigator with TTE Expertise
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstetric Anesthesia, Cardiac MonitoringStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Ching Tsen, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283931
- Sponsor's protocol ID
- 2014P002175
- Acronym
- LUDCO
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2014
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bieniarz J, Yoshida T, Romero-Salinas G, Curuchet E, Caldeyro-Barcia R, Crottogini JJ. Aortocaval compression by the uterus in late human pregnancy. IV. Circulatory homeostasis by preferential perfusion of the placenta. Am J Obstet Gynecol. 1969 Jan 1;103(1):19-31. doi: 10.1016/s0002-9378(16)34335-6. No abstract available.
PubMed 5761773Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003 Jul;97(1):256-8, table of contents. doi: 10.1213/01.ane.0000067400.79654.30.
PubMed 12818977Lewis JF, Kuo LC, Nelson JG, Limacher MC, Quinones MA. Pulsed Doppler echocardiographic determination of stroke volume and cardiac output: clinical validation of two new methods using the apical window. Circulation. 1984 Sep;70(3):425-31. doi: 10.1161/01.cir.70.3.425.
PubMed 6744546Dennis A, Stenson A. The use of transthoracic echocardiography in postpartum hypotension. Anesth Analg. 2012 Nov;115(5):1033-7. doi: 10.1213/ANE.0b013e31826cde5f. Epub 2012 Oct 9. No abstract available.
PubMed 23051881
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessement of Hemodynamic Changes Associated With Uterine Displacement Using Noninvasive Cardiac Output Monitoring and Transthoracic Echocardiography:
- ClinicalTrials.gov ID
- NCT02283931
- Acronym / sponsor ID
- LUDCO / 2014P002175
- Conditions
- Obstetric Anesthesia, Cardiac Monitoring
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Awaiting New CoInvestigator with TTE Expertise
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Nov 2014 (estimated)
- 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.
There is currently little information regarding the hemodynamic differences in uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine.
Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are becoming popular techniques in anesthesiology because they can provide noninvasive, valid, and precise hemodynamic data.There has been no study specifically examining the hemodynamic differences between the uterine displacement techniques using NICOM or TTE. While all three uterine displacement techniques are recommended, whether one technique may maximize maternal cardiac output is currently unknown.
Detailed description
Aortocaval compression is a well-recognized physiologic concern in pregnancy. The gravid uterus can compress the inferior vena cava, impeding venous return and thereby reducing stroke volume and cardiac output.
The 2014 Society for Obstetric Anesthesia and Perinatology consensus statement on the management of cardiac arrest in pregnancy, and the 2010 American Heart Association guideline on maternal cardiac arrest recommend relieving aortocaval compression during chest compressions by performing uterine displacement There is currently little information regarding the hemodynamic differences amongst the recommended uterine displacement techniques. Previous studies examining the hemodynamic effects of uterine displacement maneuvers have focused on incidence of hypotension and use of ephedrine.
Noninvasive cardiac output monitoring (NICOM) and transthoracic echocardiography (TTE) are becoming popular techniques in anesthesiology because they can provide noninvasive, valid, and precise hemodynamic data.There has been no study specifically examining the hemodynamic differences between the uterine displacement techniques using NICOM or TTE. While all three uterine displacement techniques are recommended, whether one technique may maximize maternal cardiac output is currently unknown.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One handed uterine displacement | Active comparator | Device: TTE / NICOMUterine displacement using one hand |
| two handed uterine displacement | Active comparator | Device: TTE / NICOMUterine displacement using two hands |
| 30 degrees uterine displacement | Active comparator | Device: TTE / NICOMUterine displacement using a 30 degrees wedge |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy ASA physical status I-II
- Term parturient
Key exclusion criteria (4 listed)
- Woman in labor
- Presence of maternal medical conditions affecting the cardiovascular system (including preeclampsia, gestational hypertension)
- Fetal anomaly or intrauterine growth restriction (< 25th percentile)
- Maternal renal or endocrine disease
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 |
|---|---|---|
| TTE / NICOMAlso: Transthoracic Echocardiography / Noninvasive Cardiac Output Monitor | Device | 30 degrees uterine displacement, One handed uterine displacement, two handed uterine displacement |
Primary outcome
Cardiac Output
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 5761773Bieniarz J, Yoshida T, Romero-Salinas G, Curuchet E, Caldeyro-Barcia R, Crottogini JJ. Aortocaval compression by the uterus in late human pregnancy. IV. Circulatory homeostasis by preferential perfusion of the placenta. Am J Obstet Gynecol. 1969 Jan 1;103(1):19-31. doi: 10.1016/s0002-9378(16)34335-6. No abstract available.
- Results publication: PubMed 12818977Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003 Jul;97(1):256-8, table of contents. doi: 10.1213/01.ane.0000067400.79654.30.
- Results publication: PubMed 6744546Lewis JF, Kuo LC, Nelson JG, Limacher MC, Quinones MA. Pulsed Doppler echocardiographic determination of stroke volume and cardiac output: clinical validation of two new methods using the apical window. Circulation. 1984 Sep;70(3):425-31. doi: 10.1161/01.cir.70.3.425.
- Results publication: PubMed 23051881Dennis A, Stenson A. The use of transthoracic echocardiography in postpartum hypotension. Anesth Analg. 2012 Nov;115(5):1033-7. doi: 10.1213/ANE.0b013e31826cde5f. Epub 2012 Oct 9. No abstract available.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTE / NICOM in people with Obstetric Anesthesia, Cardiac Monitoring, run by Brigham and Women's Hospital 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 4 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: paused, as of the sponsor's last update on 13 Jul 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?
Results are not available in the source record.
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?
Cardiac Output (time frame: 10 minutes). 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 NCT02283931, which also lists 4 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 13 Jul 2026.