mHealth for Hypertensive Disorder of Pregnancy

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995106
• Other study ID #: B-2308-844-302
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: June 2027

Study information

• Verified date: December 2023
• Source: Seoul National University Hospital
• Contact: Jung-Won Suh, MD
• Phone: +821076615931
• Email: suhjw1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: June 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications
• Toxemia

Intervention

Other:
• Heart4U
Mobile app.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delta SBP	Systolic Blood pressure (SBP) difference	between at the time of enrollment and one month postpartum
Secondary	Blood pressure (systolic, diastolic, mean) trajectory	BP measured at each visit	between at the time of enrollment and one month postpartum
Secondary	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)	between at the time of enrollment and one month postpartum
Secondary	Body mass index (kg/m2) trajectory	BP measured at each visit	between at the time of enrollment and one month postpartum
Secondary	trajectory of the recorded step counts	on a pedometer application within a mobile phone.	between at the time of enrollment and one month postpartum
Secondary	Depression evaluation questionnaire	Patient health questionnaires-9, Beck Depression Inventory	at the time of enrollment and one month postpartum