Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248463
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-31
Brief Title:
Blood Pressure Assessment in Waiting Room During Pregnancy
Sponsor:
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Organization:
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Study Overview
Official Title:
Automatic Blood Pressure Assessment in Waiting Room During Pregnancy Compare to 24-h Ambulatory Blood Pressure Measurement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WAPA-Pregnan
Brief Summary:
The goal of this observational study is to compare in healthy pregnant women during the first trimester The main question it aims to answer are
Accuracy of measuring automatically Blood Pressure BP at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor ABPM
Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes
Researchers will compare Systolic Blood Pressure SBP and Diastolic Blood Pressure DBP in clinical visit to see if are comparable to ABPM
Accuracy of measuring automatically Blood Pressure BP at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor ABPM
Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes
Researchers will compare Systolic Blood Pressure SBP and Diastolic Blood Pressure DBP in clinical visit to see if are comparable to ABPM
Detailed Description:
659 pregnant women will be recruitment if they In with SBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia hypertensive disease in previous pregnancy chronic hypertension chronic renal disease diabetes mellitus or autoimmune disease or any two moderate-risk factors nulliparity age 40 years BMI 35 kgm2 family history of PE or interpregnancy interval 10 years
Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app After 24h-ABPM device will be implanted Results of SBP and DBP obtained in office will be compared with 24-h diurnal and nocturnal SBPDBP mean
BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes Subsequently a SpaceLab ABPM monitor will be implanted The SBP and DBP results obtained in the waiting room will be compared with the ABPM results
Clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients
Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app After 24h-ABPM device will be implanted Results of SBP and DBP obtained in office will be compared with 24-h diurnal and nocturnal SBPDBP mean
BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes Subsequently a SpaceLab ABPM monitor will be implanted The SBP and DBP results obtained in the waiting room will be compared with the ABPM results
Clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None