NCT05995106 mHealth for Hypertensive Disorder of Pregnancy
| NCT ID | NCT05995106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Hypertensive Disorder of Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 580 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 580 participants in total. It began in 2023-10-02 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
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 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. 2. 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 Criteria: * 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.
Contact & Investigator
Jung-Won Suh, MD
PRINCIPAL INVESTIGATOR
Seoul National University Bundang Hospital
Frequently Asked Questions
Who can join the NCT05995106 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hypertensive Disorder of Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05995106 currently recruiting?
Yes, NCT05995106 is actively recruiting participants. Contact the research team at suhjw1@gmail.com for enrollment information.
Where is the NCT05995106 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea.
Who is sponsoring the NCT05995106 clinical trial?
NCT05995106 is sponsored by Seoul National University Hospital. The principal investigator is Jung-Won Suh, MD at Seoul National University Bundang Hospital. The trial plans to enroll 580 participants.