Non-invasive Haemodynamic Monitoring in Pregnancy

NCT ID: NCT03046784

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-05-31

Brief Summary

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

Detailed Description

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Conditions

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Pregnancy Related Cardiac Output, High Haemodynamic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

haemodynamic evaluation

Intervention Type 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.

Interventions

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haemodynamic evaluation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* refusal of study
* first or second trimester of pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Nord

OTHER

Sponsor Role lead

Responsible Party

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marc LEONE

Study Director, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departement anesthesie reanimation hopital nord

Marseille, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 27199309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23059960 (View on PubMed)

Other Identifiers

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darnord2017-01

Identifier Type: -

Identifier Source: org_study_id

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