Postpartum HypertensionNCT07486375
Self-Management App for Blood Pressure and Well-Being in Postpartum Women With Hypertensive Disorders of Pregnancy
A study testing Postpartum Hypertension Self-Management App (PHSMA) in people with Postpartum Hypertension and Hypertensive Disorders of Pregnancy (HDP), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Postpartum Hypertension, Hypertensive Disorders of Pregnancy (HDP)
- What is being tested?
- Postpartum Hypertension Self-Management App (PHSMA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2023to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with psychiatric disorders.
- Intrauterine fetal death in the current pregnancy.
- Infants with congenital malformations.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
- Being tested
- Postpartum Hypertension Self-Management App (PHSMA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Hypertension Self-Management App (PHSMA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 weeks postpartum
Secondary outcomes (2)
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.
Measured: Baseline to 6 weeks postpartum
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.
Measured: Baseline to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Feb 2023
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HypertensionStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486375
- Sponsor's protocol ID
- B-ER-111-434
- Other IDs
- TWNA-1121015
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07486375
- Acronym / sponsor ID
- B-ER-111-434
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management App Group | Experimental | Behavioral: Postpartum Hypertension Self-Management App (PHSMA)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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosed with psychiatric disorders.
- Intrauterine fetal death in the current pregnancy.
- Infants with congenital malformations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum 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. | Behavioural | Self-Management App Group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Health-Promoting Lifestyle Behaviors
Time frame: Baseline to 6 weeks postpartum
General Self-Efficacy Scale (GSES)
Time frame: Baseline to 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Hypertension Self-Management App (PHSMA) in people with Postpartum Hypertension and Hypertensive Disorders of Pregnancy (HDP), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Control (time frame: Baseline to 6 weeks postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.