Blood Pressure DisordersSFATI GROPENCT04943133
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.
A study testing Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis, Blood pressure measurement with the usual equipment used in the department and systematic measurement of pulse wave velocity (aortic and brachial) in people with Blood Pressure Disorders and Pregnancy Induced Hypertension, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Disorders, Pregnancy Induced Hypertension
- What is being tested?
- Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis, Blood pressure measurement with the usual equipment used in the department and systematic measurement of pulse wave velocity (aortic and brachial)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
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 :
- precise, reliable blood pressure measurement ensuring not only the diagnosis of pre-eclampsia but also the quality of monitoring, which is a prerequisite for appropriate therapeutic management;
- evaluation of the vessel walls, by detecting possible stiffness, indicating arterial damage. The aim here is to characterise the curve profile obtained in women with pre-eclampsia, at various levels of severity and also to evaluate this profile in women with a history of pre-eclampsia or at risk of pre-eclampsia. The possible specificities would then make it possible to integrate this approach into the current screening strategy in order to evaluate its interest on a larger scale.
We therefore make the following assumptions :
- the SFATI method is more reliable than the standard auscultatory method for accurately measuring brachial systolic blood pressure in pregnant women, whatever their blood pressure status;
- in women with blood pressure disorders, the oscillometric curve is modified with the presence of arterial stiffness markers, making it possible to characterise a particular oscillometric profile.
- this particular profile appears at an early stage and should make it possible to identify women at higher risk of developing pre-eclampsia.
- Being tested
- Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis, Blood pressure measurement with the usual equipment used in the department, systematic measurement of pulse wave velocity (aortic and brachial)
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurement and collection of the oscillometric curve for later SFATI analysisDevice
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.
Blood pressure measurement with the usual equipment used in the departmentDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Inclusion visit, Day 0
Presence or not of hypertensive disorders revealed using the SFATI method.
YES/NO
Measured: 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.
Measured: Inclusion visit, Day 0.
Secondary outcomes (8)
Systolic blood pressure in pregnant women whatever the gestational age : Oscillatory method (Dinamap).
The brachial systolic blood pressure of pregnant women with or without hypertensive disorders will be measured by the standard oscillatory method (Dinamap) in mmHg.
Measured: 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.
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.
Measured: 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.
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.
Measured: Inclusion visit, Day 0
Profile of the oscillometric curve processed by the SFATI algorithm. Last term of pregnancy in normal pregnancies.
Presence of hypertensive disorders.YES/NO.
Measured: 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.
Presence of hypertensive disorders.YES/NO.
Measured: 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.
Presence of a second peak on the oscillometric curve.YES/NO.
Measured: 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.
Presence of a second peak on the oscillometric curve.YES/NO.
Measured: 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.
Presence of a second peak on the oscillometric curve.YES/NO.
Measured: Inclusion visit, Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start22 Jan 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943133
- Sponsor's protocol ID
- IDIL/2020/APM-001
- Acronym
- SFATI GROPE
- Status last verified
- Sep 2021
- First submitted
- 15 Mar 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04943133
- Acronym / sponsor ID
- SFATI GROPE / IDIL/2020/APM-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 :
- precise, reliable blood pressure measurement ensuring not only the diagnosis of pre-eclampsia but also the quality of monitoring, which is a prerequisite for appropriate therapeutic management;
- evaluation of the vessel walls, by detecting possible stiffness, indicating arterial damage. The aim here is to characterise the curve profile obtained in women with pre-eclampsia, at various levels of severity and also to evaluate this profile in women with a history of pre-eclampsia or at risk of pre-eclampsia. The possible specificities would then make it possible to integrate this approach into the current screening strategy in order to evaluate its interest on a larger scale.
We therefore make the following assumptions :
- the SFATI method is more reliable than the standard auscultatory method for accurately measuring brachial systolic blood pressure in pregnant women, whatever their blood pressure status;
- in women with blood pressure disorders, the oscillometric curve is modified with the presence of arterial stiffness markers, making it possible to characterise a particular oscillometric profile.
- this particular profile appears at an early stage and should make it possible to identify women at higher risk of developing pre-eclampsia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3rd-term group: Pregnant women included in the last 3 months of pregnancy | Active comparator | 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)Comparison of the profile of the curve according to whether there is presence or absence of blood pressure disorders. |
| Before 20 weeks group. Pregnant women (normal blood pressure) included before 20 weeks of pregnancy. | Active comparator | 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 departmentComparison of the profile of the curve according to the presence or absence of risk factors for pre-eclampsia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurement and collection of the oscillometric curve for later SFATI analysisBrachial 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 | 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 departmentBrachial 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 | 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)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. | Device | 3rd-term group: Pregnant women included in the last 3 months of pregnancy |
Primary outcome
Systolic blood pressure in pregnant women whatever the gestational age : Auscultatory method
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.
Systolic blood pressure in pregnant women whatever the gestational age : SFATI method.
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.
Concordance between the auscultatory method and the SFATI method for measuring systolic blood pressure in pregnant women whatever the gestational age.
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.
Presence or not of hypertensive disorders revealed using the SFATI method.
Time frame: Inclusion visit, Day 0
YES/NO
Type of hypertensive disorders.
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.
8 secondary outcomes
Systolic blood pressure in pregnant women whatever the gestational age : Oscillatory method (Dinamap).
Time frame: 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.
Time frame: 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.
Time frame: Inclusion visit, Day 0
Profile of the oscillometric curve processed by the SFATI algorithm. Last term of pregnancy in normal pregnancies.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Inclusion visit, Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Related trials for Blood Pressure Disorders
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
A MOST Framework Trial Evaluating the MOst effectiVe Exercise Types for Blood Pressure Control
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis, Blood pressure measurement with the usual equipment used in the department and systematic measurement of pulse wave velocity (aortic and brachial) in people with Blood Pressure Disorders and Pregnancy Induced Hypertension, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure in pregnant women whatever the gestational age : Auscultatory method (time frame: Inclusion visit, Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.