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.

Summary

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.

Conditions

• Blood Pressure Disorders
• Pregnancy Induced Hypertension

Interventions

DEVICE

Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis

Brachial systolic arterial blood pressure will be systematically taken with acquisition of the oscillometric curve for analysis and measurement with the SFATI system and simultaneous electronic recording of the Korotkoff sound (auscultatory method) and a search for SFATI arterial stiffness markers for all patients. Brachial systolic arterial blood pressure will be measured with the help of a cuff equipped with a Biopac SS30L electronic stethoscope and a MA-300 phonocardiographic microphone, placed side-by-side immediately downstream from the brachial occlusion cuff. The various signals (pneumatic cuff, oscillometric signal and Korotkoff sounds) will be digitalized by an MP35 system.

DEVICE

Blood pressure measurement with the usual equipment used in the department

Brachial systolic blood pressure will be taken via the conventional oscillometric method, only for hospitalized women. Blood pressure will be measured on the same arm with the help of a conventional Dinamap-type automat (GE), with at least 2 minutes between the end of the first measurement and the start of the second inflation.

DEVICE

systematic measurement of pulse wave velocity (aortic and brachial)

Carotid to femoral and carotid to radial pulse wave velocity (Complior) will be systematically determined for hospitalized women and offered to all women seen for consultation. Pulse wave velocity will be measured with the help of a Complior tonometric system (Alam Medical, Vincennes, France), with which the aorta and the arterial axes of the upper limb used to measure blood pressure can also be measured.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-22

Primary Completion

2021-07-15

Completion

2021-07-15

Countries

• France

Study Locations