Mobile health application for managing hypertensive disorders in pregnancy

Prospective Validation of Usefulness in the Hypertensive Disorder of Pregnancy With Cardiovascular Disease Management Solution Based on Interconnection to Hospital Examination

This study is testing if a mobile app can help pregnant women with high blood pressure manage their condition better while they continue to receive regular prenatal care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 580 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Seongnam-si, Gyeonggi-do)
• Trial ID: NCT05995106 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Heart4U mobile application in helping pregnant women manage hypertensive disorders, including chronic hypertension and preeclampsia. Participants in the app group will receive guidance on using the application, which integrates with hospital electronic medical records, while both the app group and a control group will continue receiving standard prenatal care. Follow-up assessments will measure changes in systolic blood pressure at various points during pregnancy and postpartum. The primary goal is to determine if self-management through the app leads to better blood pressure control.

Who should consider this trial

Good fit: Ideal candidates include pregnant women diagnosed with hypertensive disorders of pregnancy or those at elevated risk for such conditions.

Not a fit: Patients who are not pregnant or those without hypertensive disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could empower pregnant individuals to better manage their hypertensive conditions, potentially improving maternal and fetal health outcomes.

How similar studies have performed: Other studies have shown promise in using mobile health applications for chronic disease management, suggesting potential success for this approach.

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.

Where this trial is running

Seongnam-si, Gyeonggi-do

• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)

Study contacts

• Principal investigator: Jung-Won Suh, MD — Seoul National University Bundang Hospital
• Study coordinator: Jung-Won Suh, MD

Conditions: Hypertensive Disorder of Pregnancy, Preeclampsia