Hypertension, Pregnancy Induced Hypertension
Conditions
Keywords
Hypertension in pregnancy., Blood Pressure measurement.
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTBP 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.
Sponsors
University of Salamanca
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM) | 10 mounths | Concordance of Systolic and Diastolic Blood Pressure mean between waiting room and 24-h ABMP measurements |
| Maternal | 10 months | Cardiovascular events, preeclampsia, abruptio, cesarean delivery, hemorrhage,pulmonary edema, death |
| Newborn | 10 monts | Growth restriction, preterm delivery, congenital anomalies, stillbirth, neonatal death. |
Contacts
Primary ContactJUAN F SANCHEZ MUÑOZ-TORRERO, MD
Backup ContactJONHATAN GOMEZ RAJA, MD
Outcome results
None listed