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

Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

Status: Not yet enrolling

Conditions: Pregnancy Induced Hypertension; Hypertension

Treatments: Diagnostic Test: BP measurement in waiting room for 20 minutes

Study type: Observational

Funder types: Other

Identifiers

NCT06248463

FUNDESALUD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 659 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

659 participants in 1 patient group

Woman with hypertension risk related to gestation

Description:

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)

Treatment:

Diagnostic Test: BP measurement in waiting room for 20 minutes