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NCT04943133: SFATI GROPE

Concordance Between the Systolic Foot-to-Apex Interval and the Auscultatory Method for Measuring Brachial Systolic Pressure in Pregnant Women With or Without Blood Pressure Disorders and Search for Markers of Arterial Stiffness in Pre-eclampsia.

Completed NA Last updated 28 September 2021
What this trial tests

NA trial testing Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis in Blood Pressure Disorders in 132 participants. Completed in 15 July 2021.

Timeline
22 January 2021
Primary endpoint
15 July 2021
15 July 2021

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Nīmes
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment132
Start date22 January 2021
Primary completion15 July 2021
Estimated completion15 July 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

18 and older, female only, with Blood Pressure Disorders or Pregnancy Induced Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method is an accurate means of measuring systolic blood pressure in pregnant women at a risk of pre-eclampsia. As the presence of arterial calcifications only changes the concordance between the SFATI method and the auscultatory reference method if calcifications are very severe, it should make it possible to identify, at an early stage, those women with a higher risk of developing pre-eclampsia. This is a transversal study with monocentric prospective recruitment to evaluate a non-CE (Conformité Européenne) -marked medical device in a diagnostic situation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Blood Pressure Disorders

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire de Nīmes trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04943133.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing