Nîmes University Hospital
Nîmes, Gard, 30029, France
NCT Number: NCT04943133
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Nîmes, Gard, 30029, France
During pregnancy, high blood pressure remains the leading cause of maternal and foetal morbidity and mortality due to its complications and affects 5 to 10% of pregnancies. Hypertension in pregnancy is based on measurements taken in a medical setting and is defined by a systolic blood pressure ≥ 140 mmHg and/or a diastolic ≥ 90 mmHg. Regular monitoring of blood pressure is therefore recommended during pregnancy.
However, the main difficulty lies in the unreliability of many measuring devices. One of the hypotheses that may explain this unreliability is that they are based on the analysis of the oscillometric curve. The latter is influenced by the behaviour of the arterial wall and its biomechanical properties. However, during normal pregnancy, arterial compliance is altered, particularly as a result of hypervolaemia. With hypertension and pre-eclampsia, these changes are even more pronounced.
The gold standard for measuring blood pressure remains the auscultatory method based on the detection of Korotkoff's sounds. Now, this method is being used less and less in favour of the oscillometric method and increasing use of automated devices.However, these automatons use algorithms that are neither revealed nor interchangeable and, despite them being CE marked, the majority of the devices on the market have not been validated by clinical trials in accordance with the recommendations. Validating them in pregnant women is even more problematic and it is generally accepted that most voltage measurement systems can be faulty. To improve the accuracy and reproducibility of the oscillometric method, we have developed a new algorithm for determining systolic blood pressure based on the oscillometric curve, involving a temporal analysis of the oscillometric curve, not its envelope. This original approach has made it possible to highlight an increase in the delay between the foot and the peak of the systolic peak of the oscillogram (SFATI - Systolic Foot-to-Apex Time Interval), the maximum value of which coincides with the first Korotkoff sound, thus allowing real measurement of systolic blood pressure for the first time, not just a calculation.
In addition, this parameter presents a second elevation, observed in the region of mean blood pressure in patients with cardiovascular risk factors and therefore at a risk of increased arterial stiffness. This parameter should make it possible to easily identify subjects with an arterial compliance disorder via a simple standard blood pressure measurement. This opens up many possibilities in terms of screening including on a large scale and repeated basis.
Thus, with a simple blood pressure measurement, the SFATI algorithm should make it possible to correct the inconsistencies observed with the conventional oscillometric method during pregnancy, with two advantages :
We therefore make the following assumptions :
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Inclusion visit, Day 0
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.
Time frame: Inclusion visit, Day 0
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.
Time frame: Inclusion visit, Day 0
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.
Time frame: Inclusion visit, Day 0
YES/NO
Time frame: Inclusion visit, Day 0.
If hypertensive disorders are revealed, these will be described along with the gestational age at which they were discovered.
Time frame: Inclusion visit, Day 0
The brachial systolic blood pressure of pregnant women with or without hypertensive disorders will be measured by the standard oscillatory method (Dinamap) in mmHg.
Time frame: Inclusion visit, Day 0
Lin's concordance correlation coefficient will be used to compare the brachial systolic pressure obtained with the oscillatory method and 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.
Time frame: Inclusion visit, Day 0
Lin's concordance correlation coefficient will be used to compare the brachial systolic pressure obtained with the oscillatory method and using the auscultatory method. GOOD if the lower limit of the 95% confidence interval is >0.9 and ACCEPTABLE if the lower limit is >0.8.
Time frame: Inclusion visit, Day 0
Presence of hypertensive disorders.YES/NO.
Time frame: Inclusion visit, Day 0
Presence of hypertensive disorders.YES/NO.
Time frame: Inclusion visit, Day 0
Presence of a second peak on the oscillometric curve.YES/NO.
Time frame: Inclusion visit, Day 0
Presence of a second peak on the oscillometric curve.YES/NO.
Time frame: Inclusion visit, Day 0
Presence of a second peak on the oscillometric curve.YES/NO.
Centre Hospitalier Universitaire de Nīmes
Other
Study of the Agreement Between Two Methods of Measuring Brachial Systolic Pressure (SFATI or Auscultatory) in Pregnant Women With or Without Blood Pressure Disorders and Search for Markers of Arterial Stiffness in Pre-eclampsia.
Acronym: SFATI GROPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03613714
Blood Pressure Disorders, Cardiovascular Diseases
Chapel Hill, North Carolina, United States
View Trial DetailsNCT06960057
Ambulatory Blood Pressure Monitoring, Anxiety
Jacksonville, Florida, United States
View Trial DetailsNCT04314557
Blood Pressure Disorders, Blood Pressure Variability
Madrid, Spain
View Trial DetailsNCT06236243
Aneurysm, Blood Pressure Disorders
Tarzana, California, United States
View Trial Details