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Blood Pressure Assessment in Waiting Room During Pregnancy

ConditionsHypertensionPregnancy Induced Hypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorFundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Pregnant women with suspected hypertension

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

659 Participants
are divided into 1 treatment group
Group A: Woman with hypertension risk related to gestation1 intervention

Trial outcomes

Primary outcomes

1

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
2

Maternal

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

Time frame
10 months
3

Newborn

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

Time frame
10 monts

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

University of Salamanca

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: