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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06248463
Other study ID # FUNDESALUD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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