RecruitingNot ApplicableNCT05995106

mHealth for Hypertensive Disorder of Pregnancy

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


Sponsor

Seoul National University Hospital

Enrollment

580 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mobile health app to help pregnant women manage high blood pressure (hypertension) during pregnancy. Conditions like preeclampsia and gestational hypertension can be dangerous if not closely monitored, and a smartphone app may help improve home tracking and communication with doctors. **You may be eligible if...** - You are pregnant and at least 12 weeks along - You have been diagnosed with a high blood pressure condition during pregnancy (chronic hypertension, gestational hypertension, or preeclampsia) - Your blood pressure is 140/90 mmHg or higher, or you are on blood pressure medication **You may NOT be eligible if...** - You are less than 12 weeks pregnant - You do not have a hypertensive disorder of pregnancy - You are unable to use a smartphone app Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHeart4U

Mobile app.


Locations(1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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NCT05995106


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