Cardiac Flow Measurements in Pregnant Women by Non Invasive Techniques

NCT06114147 | Unknown DMC

• 1 other identifier: 2022-D0100
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• difference in cardiac output

  Absence/low difference in cardiac output measurement (less than 30% difference) between the new non-invasive measurement methods (USCOM, ICON) and the trans thoracic echocardiography in pregnant women in the first and third trimester of pregnancy compared to the reference method which is trans thoracic echocardiography.

  18 month

Secondary Outcomes (5)

• stroke volume

  18 month

• systemic vascular resistance

  18 month

• patient satisfaction

  18 month

• user satisfaction

  18 month

• examination time

  18 month

Study Arms (1)

pregnant women

EXPERIMENTAL

pregnant women with eligibility criteria with gestational age from 12 to 16+6/7 WA and then from 32 to 36+6/7 WA.

Device: trans thoracic echocardiography measure; Device: ICON measure; Device: USCOM

Interventions

trans thoracic echocardiography measure DEVICE

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.

pregnant women

ICON measure DEVICE

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.

pregnant women

USCOM DEVICE

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

pregnant women

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any pregnant person over 16 years old followed at the prenatal consultation of the maternity ward of the Geneva University Hospitals.

You may not qualify if:

• Drug or alcohol abuse,
• Miscarriage or intra uterine demise before the first exam.
• Inability to follow the procedures of the investigation, e.g. due to psychological disorders, dementia, etc. of the subject,
• Inability to give an informed consent.
• preexisting or congenital cardiopathy
• Structural abnormalities of hearth or valves diagnosed in the first Trans Thoracic Echocardiography screening

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

Hopitaux Universitaires de Geneve

Geneva, 1205, Switzerland

RECRUITING

Study Officials

• Bénédicte LE TINIER, MD

  Hopitaux universitaires de Geneve

  PRINCIPAL INVESTIGATOR

Central Study Contacts

bénédicte LE TINIER, MD

CONTACT

0041795530127; benedictine.letinier@hcuge.ch

Begona Marinez De Tejada, PD

CONTACT

Begona.MartinezDeTejada@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor in medecine,assistant to the head of department in charge of the antenatal consultation unit, principal investigator

Model Details: prospective cross sectional study

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: March 9, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)