Blood Pressure Assessment in Waiting Room During Pregnancy

Hypertension Clinical Trial

— WAPA-Pregnan  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06248463
• Other study ID #: FUNDESALUD
• Status: Not yet recruiting
• Start date: November 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: January 2024
• Source: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
• Contact: JUAN F SANCHEZ MUÑOZ-TORRERO, MD
• Phone: 0034656259939
• Email: juanf.sanchezm[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 659
• Est. completion date: July 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Woman during the first 12 weeks of pregnancy Maternal age>35 Nulliparity Previous history of hypertension Short and long interpregnancy interval Use of assisted reproductive technologies Family history of preeclampsia Obesity. BMI>30. Hyperglycemia Renal disease Exclusion Criteria: Any inability to perform 24-h ambulatory BP measurement

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Pregnancy Induced Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura	University of Salamanca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM)	Concordance of Systolic and Diastolic Blood Pressure mean between waiting room and 24-h ABMP measurements	10 mounths
Primary	Maternal	Cardiovascular events, preeclampsia, abruptio, cesarean delivery, hemorrhage,pulmonary edema, death	10 months
Primary	Newborn	Growth restriction, preterm delivery, congenital anomalies, stillbirth, neonatal death.	10 monts