Cardiac Output Changes With Uterine Displacement (LUDCO)

August 2, 2022 updated by: Lawrence Ching Tsen, Brigham and Women's Hospital

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Healthy ASA physical status I-II
  2. Term parturient

Exclusion Criteria:

  1. Woman in labor
  2. Presence of maternal medical conditions affecting the cardiovascular system (including preeclampsia, gestational hypertension)
  3. Fetal anomaly or intrauterine growth restriction (< 25th percentile)
  4. Maternal renal or endocrine disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: One handed uterine displacement
Uterine displacement using one hand
Device: TTE / NICOM
Other Names:
  • Transthoracic Echocardiography / Noninvasive Cardiac Output Monitor
ACTIVE_COMPARATOR: two handed uterine displacement
Uterine displacement using two hands
Device: TTE / NICOM
Other Names:
  • Transthoracic Echocardiography / Noninvasive Cardiac Output Monitor
ACTIVE_COMPARATOR: 30 degrees uterine displacement
Uterine displacement using a 30 degrees wedge
Device: TTE / NICOM
Other Names:
  • Transthoracic Echocardiography / Noninvasive Cardiac Output Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac Output
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (ESTIMATE)

November 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2014P002175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstetric Anesthesia, Cardiac Monitoring

Clinical Trials on TTE / NICOM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe