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Cardiac Flow Measurements in Pregnant Women by Non Invasive Techniques

NCT06114147 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-15

No results posted yet for this study

Summary

the goal of this clinical trial is to compare the measurement of cardiac output, systolic ejection volume and vascular filling in pregnant women with the new non-invasive measurement techniques of the Index of contractility monitor (ICON) and the Ultra Sonic Cardiac Output Monitor (USCOM) in pregnant women compared to trans-thoracic ultrasound as the gold standard of non-invasive techniques The Secondary objective is to evaluate patient comfort between the 3 techniques, examination time and examiner satisfaction.

The main question it aim to answer is the absence or a low difference in cardiac output measurement ( less than 30 %) between the non invasive measurement methods ( USCOM/ICON) and the trans thoracic cardiac echography in pregnant women in the first and third trimester.

Conditions

  • Pregnancy Related
  • Cardiac Output

Interventions

DEVICE

trans thoracic echocardiography measure

The trans thoracic echography would be carried out with cardiac classic sections to ensure the structural cardiac and valvular normality and then sections repeated 3 times over 10 minutes will be carried out to calculate the cardiac output.

DEVICE

ICON measure

The ICON will be placed at the beginning of the consultation and the measurements will be taken at the same time as the trans thoracic ultrasound in the left lateral decubitus position.

DEVICE

USCOM

Afterwards, measurements will be made with USCOM in left lateral position and 3 of the best spectra archived according to the Fremantle score.

Sponsors & Collaborators

  • University of Geneva, Switzerland

    lead OTHER

Principal Investigators

  • Bénédicte LE TINIER, MD · Hopitaux universitaires de Geneve

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2024-04-30
Completion
2024-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114147 on ClinicalTrials.gov