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NCT Number: NCT05995106

mHealth for Hypertensive Disorder of Pregnancy

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.

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Key information

Conditions

Hypertensive Disorder of Pregnancy Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Infections Pre-Eclampsia Preeclampsia Pregnancy Complications Toxemia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

Location status: Recruiting

Location contact

Jung-Won Suh

CONTACT

[email protected]

82-31-787-7016

About this study

Inclusion criteria

  • 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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Heart4U

Other

Mobile app.

Primary outcomes

  1. delta SBP

    Time frame: between at the time of enrollment and one month postpartum

    Systolic Blood pressure (SBP) difference

Secondary outcomes

  1. Blood pressure (systolic, diastolic, mean) trajectory

    Time frame: between at the time of enrollment and one month postpartum

    BP measured at each visit

  2. obstetric outcomes

    Time frame: between at the time of enrollment and one month postpartum

    (The use of antihypertensive medication, progression to eclampsia or preeclampsia, pulmonary edema, fetal growth restriction, oligohydramnios, premature placental abruption, preterm birth (delivery between 20 and less than 37 weeks of gestation)

  3. Body mass index (kg/m2) trajectory

    Time frame: between at the time of enrollment and one month postpartum

    BP measured at each visit

  4. trajectory of the recorded step counts

    Time frame: between at the time of enrollment and one month postpartum

    on a pedometer application within a mobile phone.

  5. Depression evaluation questionnaire

    Time frame: at the time of enrollment and one month postpartum

    Patient health questionnaires-9, Beck Depression Inventory

Study contacts

Contact information is provided by the study sponsor or research team.

Hye-Jin Kim, RN

CONTACT

[email protected]

+82317877016

Jung-Won Suh, MD

CONTACT

[email protected]

+821076615931

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 16, 2023
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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