Self-Management App for Blood Pressure and Well-Being in Postpartum Women With Hypertensive Disorders of Pregnancy

NCT07486375 | Completed

• 2 other identifiers: B-ER-111-434TWNA-1121015
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertensive disorders of pregnancy (HDP) are a major cause of maternal morbidity and may continue to affect women after childbirth. Effective postpartum self-management is important for controlling blood pressure (BP) and improving overall health. eHealth applications may provide convenient tools to support self-monitoring and promote healthy behaviors. The purpose of this randomized controlled trial is to evaluate the effectiveness of a self-management application for postpartum women with hypertensive disorders of pregnancy (HDP). Participants are randomly assigned to either a self-management app intervention group or a usual care group. The study assesses whether the application improves blood pressure (BP)control, psychological well-being (stress and depression), and health-promoting lifestyle behaviors among postpartum women.

Conditions

Postpartum Hypertension; Hypertensive Disorders of Pregnancy (HDP)

Outcome Measures

Primary Outcomes (4)

• Blood Pressure Control

  Change in systolic and diastolic blood pressure (BP) among postpartum women with hypertensive disorders of pregnancy (HDP). Using an electric sphygmomanometer, women were instructed to measure their BP twice daily, 7-10 am and 5-8 pm after discharge.

  Baseline to 6 weeks postpartum

• Perceived Stress

  Change in perceived stress levels among postpartum women. Perceived stress was measured using the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses perceived stress over the past month. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (almost always), with total scores ranging from 0 to 40. Higher scores indicate greater perceived stress.

  Baseline to 6 weeks postpartum

• Postpartum Stress

  Change in postpartum stress levels among postpartum women. Postpartum stress was measured using the Hung Postpartum Stress Scale (HPPS), a 62-item instrument designed to assess postpartum stress during the six-week postpartum period. Each item is rated on a 5-point Likert scale from 1 (not at all) to 5 (always), with total scores ranging from 62 to 310. Higher scores indicate higher levels of postpartum stress.

  Baseline to 6 weeks postpartum

• Postpartum depression

  Change in postpartum depressive symptoms. Depressive symptoms were measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report questionnaire that assesses depressive symptoms over the past seven days. Each item is scored on a 4-point Likert scale from 0 to 3, with total scores ranging from 0 to 30. Higher scores indicate more severe depressive symptoms.

  Baseline to 6 weeks postpartum

Secondary Outcomes (1)

• Health-Promoting Lifestyle Behaviors

  Baseline to 6 weeks postpartum

Study Arms (2)

Self-Management App Group

EXPERIMENTAL

Participants in this group receive access to the self-management application to support postpartum health management, including blood pressure monitoring, health education, lifestyle guidance, and professional consultation during the postpartum period.

Behavioral: Postpartum Hypertension Self-Management App (PHSMA)

Usual Care Group

NO INTERVENTION

Participants in this group received routine postpartum care according to standard clinical practice. They used paper-based records to monitor and document postpartum blood pressure.

Interventions

Postpartum Hypertension Self-Management App (PHSMA) BEHAVIORAL

The Postpartum Hypertension Self-Management App (PHSMA) was developed by our research team (Chang et al., 2023 ), and it is suitable for iOS and Android systems. Designed to enhance knowledge and support self-management in postpartum women with HDP. The app allows users to upload, monitor, and review personal health records related to postpartum hypertension. The app contents were designed by a comprehensive literature review and expert consensus, addressing key needs in postpartum HDP care, including continuity of care, medication and emotional management, and access to health information and professional consultation. The PHSMA includes six interactive modules: (1) HDP knowledge, (2) Postpartum monitoring and self-management of physiological data, (3) Medication management, (4) Nursing care and mental health education for HDP, (5) Lifestyle and health promotion strategies, and (6) Consulting platform for healthcare professionals.

Self-Management App Group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum women aged 20 years or older.
• Diagnosed with hypertensive disorders of pregnancy (HDP).
• Have access to the internet via a mobile phone.
• Own a home blood pressure monitor.

You may not qualify if:

• Diagnosed with psychiatric disorders.
• Intrauterine fetal death in the current pregnancy.
• Infants with congenital malformations.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Tainan City, 704, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 20, 2026
• Study Start: February 15, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2023
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)