mHealth for Hypertensive Disorder of Pregnancy

Last updated: December 15, 2023
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Pregnancy Complications

Stress

Treatment

Heart4U

Clinical Study ID

NCT05995106
B-2308-844-302
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • Diagnosis: 1 or 2
  1. Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12weeks of gestation:
  • Chronic hypertension: Diagnosed with hypertension within 20 weeks ofgestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currentlyon antihypertensive medication.
  • Gestational hypertension: Newly diagnosed with hypertension after 20 weeksof gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) orcurrently on antihypertensive medication.
  • Preeclampsia: Newly diagnosed with hypertension after 20 weeks of gestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currently onantihypertensive medication, and presents with proteinuria (300 mg/24 hoursor urine protein-to-creatinine ratio ≥0.3), thrombocytopenia (less than 100,000 platelets per microliter), abnormal renal function (creatinineexceeding 1.1 or doubling of baseline), elevated liver enzymes (twice normallevels), neurological symptoms (headache, visual disturbances, seizures,etc.), and/or pulmonary edema.
  • Superimposed preeclampsia: Diagnosed with hypertension within 20 weeks ofgestation (elevated office/clinic blood pressure ≥140/90 mm Hg) or currentlyon antihypertensive medication and experiences symptoms or signs related tosuperimposed preeclampsia.
  1. 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, presenceof borderline blood pressure readings during antepartum care (elevatedoffice/clinic blood pressure ≥130/80 mm Hg) following a previous diagnosis ofhypertension-related disorder in a prior pregnancy. , and
  • Adult individuals aged 18 years and above who possess a smartphone and are capable ofindependently utilizing the application among pregnant women.

Exclusion

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 variousreasons.
  • Cases where device familiarity is significantly low, making data collectionchallenging.
  • Pregnant patients requiring immediate electronic fetal monitoring or maternalmonitoring due to imminent delivery.

Study Design

Total Participants: 580
Treatment Group(s): 1
Primary Treatment: Heart4U
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggi-do 463707
    Korea, Republic of

    Active - Recruiting

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