NCT05995106Terminated
mHealth for Hypertensive Disorder of Pregnancy
Prospective Validation of Usefulness in the Hypertensive Disorder of Pregnancy With Cardiovascular Disease Management Solution Based on Interconnection to Hospital Examination
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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. The main goal of this study is to evaluate the clinical effectiveness of a treatment approach that entails self-management of risk factors through a mobile application among pregnant individuals diagnosed with hypertensive cardiovascular conditions. Methods: Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage. Both the app group and the usual care group continue to receive active treatment as previously administered (guideline-based prenatal care). Follow-up observations occur at each obstetric examination prior to delivery and are conducted again at the first month postpartum. The primary endpoint of observation pertains to the difference in systolic blood pressure between the enrollment and study completion time points.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 89 (actual)
- First submitted
- 9 Aug 2023
- Start date
- 2 Oct 2023
- Primary completion date
- 29 Apr 2026
- Lead sponsor
- Seoul National University Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05995106
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with evidence of delusions, confusion, or other cognitive disorders.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.