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.

NCT04943133 | Completed

• 1 other identifier: IDIL/2020/APM-001
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Systolic blood pressure in pregnant women whatever the gestational age : Auscultatory method

  The brachial systolic blood pressure of pregnant women with or without hypertensive disorders will be measured by the standard auscultatory method based on the Korotkoff sounds, in mmHg.

  Inclusion visit, Day 0

• Systolic blood pressure in pregnant women whatever the gestational age : SFATI method.

  The brachial systolic blood pressure of pregnant women with or without hypertensive disorders will be measured by the SFATI (Systolic Foot-to-Apex Time Interval) method.

  Inclusion visit, Day 0

• Concordance between the auscultatory method and the SFATI method for measuring systolic blood pressure in pregnant women whatever the gestational age.

  Lin's concordance correlation coefficient will be used to compare the simultaneous recording of Korotkoff sound and the brachial systolic pressure using the SFATI method. Good if the lower limit of the 95% confidence interval is \>0.9 and ACCEPTABLE if the lower limit is \>0.8.

  Inclusion visit, Day 0

• Presence or not of hypertensive disorders revealed using the SFATI method.

  YES/NO

  Inclusion visit, Day 0

• Type of hypertensive disorders.

  If hypertensive disorders are revealed, these will be described along with the gestational age at which they were discovered.

  Inclusion visit, Day 0.

Secondary Outcomes (8)

• Systolic blood pressure in pregnant women whatever the gestational age : Oscillatory method (Dinamap).

  Inclusion visit, Day 0

• Concordance between the SFATI method and the conventional oscillatory method for blood pressure monitoring (Dinamap), in pregnant women with or without hypertensive disorders, whatever the gestational age.

  Inclusion visit, Day 0

• Concordance between the conventional oscillatory method (Dinamap), and the auscultatory method for blood pressure monitoring in pregnant women with or without hypertensive disorders, whatever the gestational age.

  Inclusion visit, Day 0

• Profile of the oscillometric curve processed by the SFATI algorithm. Last term of pregnancy in normal pregnancies.

  Inclusion visit, Day 0

• Profile of the oscillometric curve processed by the SFATI algorithm. Last term of pregnancy in women with hypertensive disorders or pre-eclampsia.

  Inclusion visit, Day 0

Study Arms (2)

3rd-term group: Pregnant women included in the last 3 months of pregnancy

ACTIVE COMPARATOR

Comparison of the profile of the curve according to whether there is presence or absence of blood pressure disorders.

Device: Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis; Device: Blood pressure measurement with the usual equipment used in the department; Device: systematic measurement of pulse wave velocity (aortic and brachial)

Before 20 weeks group. Pregnant women (normal blood pressure) included before 20 weeks of pregnancy.

ACTIVE COMPARATOR

Comparison of the profile of the curve according to the presence or absence of risk factors for pre-eclampsia

Device: Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis; Device: Blood pressure measurement with the usual equipment used in the department

Interventions

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

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.

3rd-term group: Pregnant women included in the last 3 months of pregnancy; Before 20 weeks group. Pregnant women (normal blood pressure) included before 20 weeks of pregnancy.

Blood pressure measurement with the usual equipment used in the department DEVICE

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.

3rd-term group: Pregnant women included in the last 3 months of pregnancy; Before 20 weeks group. Pregnant women (normal blood pressure) included before 20 weeks of pregnancy.

systematic measurement of pulse wave velocity (aortic and brachial) DEVICE

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.

3rd-term group: Pregnant women included in the last 3 months of pregnancy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient monitored for a single pregnancy in consultation or hospitalized in the department of Gynecology-Obstetrics at Nîmes University Hospital.
• Patient has given written informed consent.
• Patient has signed the consent form.
• Patient is covered by a health insurance scheme.
• Patient is aged over 18.

You may not qualify if:

• Multiple pregnancy.
• Patient is taking part in a category 1 research study.
• Patient is under legal protection or curatorship.
• Patient is in no condition to express her consent.
• Patient for whom it is impossible to give clear information.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: June 29, 2021
• Study Start: January 22, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

FR (1)