mHealth for Hypertensive Disorder of Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSeoul National University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Diagnosis: 1 or 2
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Heart4U
Other interventionMobile app.
Treatment groups
580 Participants
are divided into 2 treatment groupsGroup A: App GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
delta SBP
Systolic Blood pressure (SBP) difference
Time frame
between at the time of enrollment and one month postpartumSecondary outcomes
1
Blood pressure (systolic, diastolic, mean) trajectory
BP measured at each visit
Time frame
between at the time of enrollment and one month postpartum2
obstetric outcomes
(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)
Time frame
between at the time of enrollment and one month postpartum3
Body mass index (kg/m2) trajectory
BP measured at each visit
Time frame
between at the time of enrollment and one month postpartum4
trajectory of the recorded step counts
on a pedometer application within a mobile phone.
Time frame
between at the time of enrollment and one month postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov