Non-invasive Haemodynamic Monitoring in Pregnancy

NCT03046784 | Completed

• 1 other identifier: darnord2017-01
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic

Conditions

Pregnancy Related; Cardiac Output, High; Haemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Cardiac output measure

  Cardiac output is measured with non-invasive digital Nexfin technology (ml/min) and compared with transthoracic echocardiographic measure of cardiac output (ml/min) used as reference. Echographic cardiac output (ml/min) is measured as the produce of cross sectional aera of left ventricular outflow track (cm²) multiplied by velocity time index (cm) multiplied by heart rate (beat/min)

  30 minutes

Study Arms (1)

Pregnant women in third trimester

Non-labouring pregnant women hospitalised during their third trimester of pregnancy has an haemodynamic evaluation with Nexfin technology and transthoracic cardiac ultrasonography. Evaluation is performed in two positions : dorsal decubitus and left lateral decubitus.

Other: haemodynamic evaluation

Interventions

haemodynamic evaluation OTHER

continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.

Pregnant women in third trimester

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: pregmant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-labouring term pregmant women in their third trimester

You may qualify if:

• third trimester of pregnancy
• Non-labouring pregnant women
• accepting study

You may not qualify if:

• refusal of study
• first or second trimester of pregnancy

Sponsors & Collaborators

• Hospital Nord: lead

Study Sites (1)

Departement anesthesie reanimation hopital nord

Marseille, 13015, France

Location

Related Publications (2)

• Montenij LJ, Buhre WF, Jansen JR, Kruitwagen CL, de Waal EE. Methodology of method comparison studies evaluating the validity of cardiac output monitors: a stepwise approach and checklist. Br J Anaesth. 2016 Jun;116(6):750-8. doi: 10.1093/bja/aew094.

  PMID: 27199309 BACKGROUND

• Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.

  PMID: 23059960 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, High

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director, Clinical Professor

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 8, 2017
• Study Start: January 1, 2017
• Primary Completion: March 31, 2017
• Study Completion: May 31, 2017
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)