NCT06248463

Blood Pressure Assessment in Waiting Room During Pregnancy

Automatic Blood Pressure Assessment in Waiting Room During Pregnancy Compare to 24-h Ambulatory Blood Pressure Measurement

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 659 (estimated)
• Sponsor: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 kg/m2, 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 SBP/DBP 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.

Conditions

• Hypertension
• Pregnancy Induced Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BP measurement in waiting room for 20 minutes	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 SBP/DBP 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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-31
• Completion: 2026-07-01
• First posted: 2024-02-08
• Last updated: 2024-02-12