Blood Pressure Assessment in Waiting Room During Pregnancy (WAPA-Pregnan)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Pregnancy Induced Hypertension
• Intervention / Treatment: Diagnostic test: BP measurement in waiting room for 20 minutes

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.

• Study Type: Observational
• Enrollment (Estimated): 659

Contacts and Locations

• Study Contact: Name: JUAN F SANCHEZ MUÑOZ-TORRERO, MD; Phone Number: 0034656259939; Email: juanf.sanchezm@gmail.com
• Study Contact Backup: Name: JONHATAN GOMEZ RAJA, MD; Phone Number: 34 620962640; Email: jonathan.gomez@fundesalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with suspected hypertension

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Woman with hypertension risk related to gestation; 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)

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.; Other Names: ABPM-24 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn	Growth restriction, preterm delivery, congenital anomalies, stillbirth, neonatal death.	10 monts
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
Maternal	Cardiovascular events, preeclampsia, abruptio, cesarean delivery, hemorrhage,pulmonary edema, death	10 months

Collaborators and Investigators

• Sponsor: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
• Collaborators: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Blood Pressure measurement.; Hypertension in pregnancy.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: FUNDESALUD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No