Blood Pressure Assessment in Waiting Room During Pregnancy

NCT06248463 | Not Yet Recruiting DMC

• 1 other identifier: FUNDESALUD
• Study Type: observational
• Target: 659
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension; Pregnancy Induced Hypertension

Keywords

Hypertension in pregnancy.; Blood Pressure measurement.

Outcome Measures

Primary Outcomes (3)

• 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

• Newborn

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

  10 monts

Study Arms (1)

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

Interventions

BP measurement in waiting room for 20 minutes DIAGNOSTIC_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.

Also known as: ABPM-24 h

Woman with hypertension risk related to gestation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Gestation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with suspected hypertension

You may qualify if:

• 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

You may not qualify if:

• Any inability to perform 24-h ambulatory BP measurement

Sponsors & Collaborators

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

MeSH Terms

Conditions

Hypertension; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

JUAN F SANCHEZ MUÑOZ-TORRERO, MD

CONTACT

0034656259939; juanf.sanchezm@gmail.com

JONHATAN GOMEZ RAJA, MD

CONTACT

34 620962640; jonathan.gomez@fundesalud.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 12, 2024

Record last verified: 2024-01