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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Systolic blood pressure in pregnant women whatever the gestational age : Auscultatory method
研究概览
简要总结
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.
详细描述
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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Multiple pregnancy.
- •Patient is taking part in a category 1 research study.
- •Patient is in a period of exclusion determined by another 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.
结局指标
主要结局
Systolic blood pressure in pregnant women whatever the gestational age : Auscultatory method
时间窗: 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.
Presence or not of hypertensive disorders revealed using the SFATI method.
时间窗: Inclusion visit, Day 0
YES/NO
Systolic blood pressure in pregnant women whatever the gestational age : SFATI method.
时间窗: 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.
Type of hypertensive disorders.
时间窗: Inclusion visit, Day 0.
If hypertensive disorders are revealed, these will be described along with the gestational age at which they were discovered.
Concordance between the auscultatory method and the SFATI method for measuring systolic blood pressure in pregnant women whatever the gestational age.
时间窗: 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.
次要结局
- 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)
- Systolic blood pressure in pregnant women whatever the gestational age : Oscillatory method (Dinamap).(Inclusion visit, Day 0)
- Profile of the oscillometric curve processed by the SFATI algorithm before 20 weeks of pregnancy in women with or without a risk of hypertensive disorders.(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)
- Profile of the oscillometric curve processed by the SFATI algorithm according to aortic pulse wave velocity in women with (>9 m/s) or with no acceleration of aortic pulse wave velocity.(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)
- 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)
- Profile of the oscillometric curve processed by the SFATI algorithm according to brachial pulse wave velocity in women with (>12 m/s) or with no acceleration of brachial pulse wave velocity.(Inclusion visit, Day 0)