Cardiac Output Changes With Uterine Displacement | NCT02283931

Studies
Cardiac Output Changes With Uterine Displacement

NCT02283931

Sponsor

Brigham and Women's Hospital

Status

Suspended

Last Update Posted

Aug 3, 2022Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Obstetric Anesthesia, Cardiac Monitoring

Interventions

TTE / NICOM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Awaiting New CoInvestigator with TTE Expertise

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Nov 3, 2014

First Submission Date that Met QC Criteria

Nov 3, 2014

First Posted Date

Nov 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lawrence Ching Tsen, Associate Professor, Harvard Medical School, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One handed uterine displacement	Active Comparator	Uterine displacement using one hand	Device: TTE / NICOM
two handed uterine displacement	Active Comparator	Uterine displacement using two hands	Device: TTE / NICOM
30 degrees uterine displacement	Active Comparator	Uterine displacement using a 30 degrees wedge	Device: TTE / NICOM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TTE / NICOM	Device		30 degrees uterine displacement One handed uterine displacement two handed uterine displacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac Output		10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy ASA physical status I-II
Term parturient

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
5761773	Result	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.
12818977

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis