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Completed

NCT Number: NCT07486375

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

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.

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Key information

Conditions

Postpartum Hypertension Hypertensive Disorders of Pregnancy (HDP)

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, Tainan City, 704, Taiwan

About this study

Hypertensive disorders of pregnancy (HDP) are among the leading causes of maternal morbidity worldwide and may have persistent health effects during the postpartum period. Women with HDP are at increased risk of sustained hypertension and adverse cardiovascular outcomes after childbirth. Effective postpartum self-management, including blood pressure (BP) monitoring, psychological well-being, and the adoption of healthy lifestyle behaviors, is essential for improving long-term maternal health.

eHealth technologies have been increasingly used to support patient self-management by providing accessible health information, self-monitoring tools, and behavioral support. However, evidence regarding mobile applications specifically designed for postpartum women with HDP remains limited.

This randomized controlled trial evaluates the effectiveness of a self-management mobile application designed for postpartum women with hypertensive disorders of pregnancy (HDP). Eligible participants are randomly assigned to either an intervention group receiving the self-management application or a usual care control group. The intervention supports blood pressure (BP) monitoring, health education, and lifestyle management during the postpartum period.

This study aim to investigate the effectiveness of a self-management mobile App on blood pressure, stress, depression, and health-promoting lifestyles among postpartum women with hypertensive disorders of pregnancy (HDP).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Blood Pressure Control

    Time frame: Baseline to 6 weeks postpartum

    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.

  2. Perceived Stress

    Time frame: Baseline to 6 weeks postpartum

    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.

  3. Postpartum Stress

    Time frame: Baseline to 6 weeks postpartum

    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.

  4. Postpartum depression

    Time frame: Baseline to 6 weeks postpartum

    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.

Secondary outcomes

  1. Health-Promoting Lifestyle Behaviors

    Time frame: Baseline to 6 weeks postpartum

    Change in health-promoting lifestyle behaviors among postpartum women with hypertensive disorders of pregnancy (HDP). Health-promoting lifestyle behaviors were measured using the Health-Promoting Lifestyle Profile Short Scale (HPLP-S), a 24-item instrument that assesses six dimensions: self-actualization, health responsibility, physical activity, nutrition, interpersonal support, and stress management. Each item is rated on a 4-point Likert scale, with total scores ranging from 24 to 96. Higher scores indicate better health-promoting lifestyle behaviors.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Effects of a Self-management App on Blood Pressure, Stress, and Depression and Health-Promoting Lifestyles in Postpartum Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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