Blood Pressure Assessment in Waiting Room During Pregnancy

N/ANot Yet RecruitingNCT06248463

Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura659 enrolled

Overview

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.

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

659

Conditions

Hypertension Pregnancy Induced Hypertension

BP measurement in waiting room for 20 minutesDIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 10 mounths

Maternal

Cardiovascular events, preeclampsia, abruptio, cesarean delivery, hemorrhage,pulmonary edema, death

Time frame: 10 months

Newborn

Growth restriction, preterm delivery, congenital anomalies, stillbirth, neonatal death.

Time frame: 10 monts