RecruitingRecruiting
mHealth for Hypertensive Disorder of Pregnancy
NCT05995106 · Seoul National University Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Prospective Validation of Usefulness in the Hypertensive Disorder of Pregnancy With Cardiovascular Disease Management Solution Based on Interconnection to Hospital Examination
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 580 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-02
Estimated completion: 2027-06
Last updated: 2023-12-21
Interventions
Other: Heart4U
Primary outcomes
- • delta SBP (between at the time of enrollment and one month postpartum)
Sponsor
Seoul National University Hospital · other
Contacts & investigators
ContactJung-Won Suh, MD · contact · suhjw1@gmail.com · +821076615931
ContactHye-Jin Kim, RN · contact · kimhj258@gmail.com · +82317877016
InvestigatorJung-Won Suh, MD · principal_investigator, Seoul National University Bundang Hospital
All locations (1)
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea