Status:
RECRUITING
mHealth for Hypertensive Disorder of Pregnancy
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hypertensive Disorder of Pregnancy
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Objectives: We have developed a cardiovascular disease management application named Heart4U, with the capability of integrating with the Electronic Medical Records (EMR) system within the hospital. T...
Detailed Description
Inclusion Criteria: * Diagnosis: 1 or 2 1. Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12 weeks of gestation: * Chronic hypertension: Diagnosed with hypert...
Eligibility Criteria
Inclusion
- Diagnosis: 1 or 2
- Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12 weeks of gestation:
- Chronic hypertension: Diagnosed with hypertension within 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication.
- Gestational hypertension: Newly diagnosed with hypertension after 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication.
- Preeclampsia: Newly diagnosed with hypertension after 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication, and presents with proteinuria (300 mg/24 hours or urine protein-to-creatinine ratio ≥0.3), thrombocytopenia (less than 100,000 platelets per microliter), abnormal renal function (creatinine exceeding 1.1 or doubling of baseline), elevated liver enzymes (twice normal levels), neurological symptoms (headache, visual disturbances, seizures, etc.), and/or pulmonary edema.
- Superimposed preeclampsia: Diagnosed with hypertension within 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently on antihypertensive medication and experiences symptoms or signs related to superimposed preeclampsia.
- Pregnant women at elevated risk for hypertensive disorders of pregnancy:
- Multifetal gestation, obesity, uncontrolled gestational or pre-existing diabetes, history of hypertensive disorder of pregnancy leading to preterm birth, presence of borderline blood pressure readings during antepartum care (elevated office/clinic blood pressure ≥130/80 mm Hg) following a previous diagnosis of hypertension-related disorder in a prior pregnancy.
- , and
- Adult individuals aged 18 years and above who possess a smartphone and are capable of independently utilizing the application among pregnant women.
Exclusion
- Patients with evidence of delusions, confusion, or other cognitive disorders.
- Patients deemed difficult to conduct this study on by the researchers due to various reasons.
- Cases where device familiarity is significantly low, making data collection challenging.
- Pregnant patients requiring immediate electronic fetal monitoring or maternal monitoring due to imminent delivery.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT05995106
Start Date
October 2 2023
End Date
June 1 2027
Last Update
December 21 2023
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463707