Actively Recruiting
mHealth for Hypertensive Disorder of Pregnancy
Led by Seoul National University Hospital · Updated on 2023-12-21
580
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
mHealth for Hypertensive Disorder of Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women diagnosed with hypertensive disorders of pregnancy at or beyond 12 weeks of gestation, including chronic hypertension, gestational hypertension, preeclampsia, or superimposed preeclampsia
- Pregnant women at elevated risk for hypertensive disorders of pregnancy, such as those with multifetal gestation, obesity, uncontrolled gestational or pre-existing diabetes, history of hypertensive disorder causing preterm birth, or borderline blood pressure readings after prior hypertension-related pregnancy
- Adults aged 18 years and above who have a smartphone and can use the application independently
You will not qualify if you...
- Patients with delusions, confusion, or other cognitive disorders
- Patients considered difficult to include in the study by researchers
- Individuals unfamiliar with devices, making data collection difficult
- Pregnant patients needing immediate electronic fetal or maternal monitoring due to imminent delivery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463707
Actively Recruiting
Research Team
J
Jung-Won Suh, MD
CONTACT
H
Hye-Jin Kim, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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