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CompletedNCT07486375Updated Sep 11, 2026

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

An interventional study of Postpartum Hypertension Self-Management App (PHSMA) in Postpartum Hypertension and Hypertensive Disorders of Pregnancy (HDP), sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Feb 2023, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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).

02

Conditions studied

  • Postpartum Hypertension
  • Hypertensive Disorders of Pregnancy (HDP)
03

In context

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Diagnosed with psychiatric disorders.
  • Intrauterine fetal death in the current pregnancy.
  • Infants with congenital malformations.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    Self-Management App Group

    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)

  • No intervention
    Usual Care Group

    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

  • BehavioralPostpartum Hypertension Self-Management App (PHSMA)

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 6 weeks postpartum

  2. 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.

    Time frame: Baseline to 6 weeks postpartum

  3. 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.

    Time frame: Baseline to 6 weeks postpartum

  4. 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.

    Time frame: Baseline to 6 weeks postpartum

Secondary outcomes

  1. Health-Promoting Lifestyle Behaviors

    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.

    Time frame: Baseline to 6 weeks postpartum

  2. General Self-Efficacy Scale (GSES)

    Change in general self-efficacy among postpartum women with hypertensive disorders of pregnancy (HDP). General self-efficacy was measured using the General Self-Efficacy Scale (GSES), a 10-item instrument that assesses an individual's perceived ability to cope with difficult situations and challenges. Each item is rated on a 4-point Likert scale, with total scores ranging from 10 to 40. Higher scores indicate greater general self-efficacy.

    Time frame: Baseline to 6 weeks postpartum

07

Study locations

1 site
  • National Cheng Kung University Hospital
    Tainan, Tainan City 704, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07486375
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Mar 20, 2026
Start date
Feb 15, 2023
Primary completion
Dec 25, 2023
Completion
Dec 25, 2023
Last update
Sep 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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