mHealth for Hypertensive Disorder of Pregnancy

Seoul National University

Status: Enrolling

Conditions: Preeclampsia; Hypertensive Disorder of Pregnancy

Treatments: Other: Heart4U

Study type: Interventional

Funder types: Other

Identifiers

NCT05995106

B-2308-844-302

Details and patient eligibility

About

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.

Full 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 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.

• Adult individuals aged 18 years and above who possess a smartphone and are capable of independently utilizing the application, among pregnant women.

Enrollment: 580 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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580 participants in 2 patient groups

App Group

Experimental group

Description:

Patients assigned to the app group receive assistance from the research team to install the Heart4U application and familiarize themselves with its usage.

Treatment:

Other: Heart4U

Usual Care Group

No Intervention group

Description:

The app (n=290) and usual care groups (n-290) continue to receive active treatment as previously administered (guideline-based prenatal care).