Hypertension Clinical Trial
— WAPA-PregnanOfficial title:
Automatic Blood Pressure Assessment in Waiting Room During Pregnancy Compare to 24-h Ambulatory Blood Pressure Measurement
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura | University of Salamanca |
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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