Hypertensive Disorders of Pregnancy (HDP)PenelopeNCT07621133
Cost-Effectiveness of an mHealth Application in Pregnancy Care
A study testing mHealth application Penelope in people with Hypertensive Disorders of Pregnancy (HDP) and Maternal Health Care, run by Principal Engineering s.r.o. at 1 site in Czechia.
Trial summary
Participants will be randomly assigned to either the intervention arm (mHealth application users) or the control arm, in which participants will record their data on paper or in Excel according to standard practice or the recommendation of their study physician. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy (HDP), Maternal Health Care, Mobile Health Technology (mHealth)
- What is being tested?
- mHealth application Penelope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Oct 2025to 18 Aug 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years. Each participant will be enrolled in the study no earlier than the 20th week of pregnancy.
- Presence of at least one primary risk factor:
- Pre-gestational hypertension.
- Gestational hypertension.
- Positive screening for preeclampsia.
- The presence of additional secondary risk factors (e.g., controlled type 1 or type 2 diabetes mellitus, obesity with BMI ≥ 30) may be recorded but is not sufficient on its own for inclusion in the study without meeting at least one primary criterion.
Who cannot join
- Uncontrolled diabetes and/or diabetes during the last 3 months prior to enrolment in this study.
- Presence of a gynaecological disease that increases the risk of pregnancy complications, except for those conditions specifically listed in the inclusion criteria (e.g., chronic hypertension, gestational hypertension, pre-gestational hypertension, diabetes mellitus, obesity, or morbid obesity).
- Participant with active malignant disease.
- Participant with alcohol or drug abuse during the recruitment and during the trial course.
- Participant enrolled in another clinical trial during the last 3 months prior to enrolling in this study.
- Participants who, in the opinion of the study physician, may interfere with optimal participation in the study or may pose a risk to the participant.
- Characteristics indicating a poor understanding of the study or characteristics that indicate the participant may have poor compliance with the study protocol.
- Participants with severe or uncontrolled depression, which in the opinion of the study physician could influence participant's participation in the study; participants with stable depression and/or on a stable dose of an anti-depressant for at least three months may be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-Effectiveness of an mHealth Application in Pregnancy Care: A Randomized Multi-Center Study Comparing Penelope Users and Non-Users
Participants will be randomly assigned to either the intervention arm (mHealth application users) or the control arm, in which participants will record their data on paper or in Excel according to standard practice or the recommendation of their study physician.
Read the detailed description
Participants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyze a range of health-related data, including self-reported symptoms, blood pressure measurements, and proteinuria test results. The application processes these data and evaluates the degree of deviation of measured values from predefined normal ranges. Each parameter is assessed on a scale of 1 to 3, with threshold values indicating increased risk established in collaboration with the study physician and in accordance with standards of care.
The study physician is informed of deviations from normal values through color-coded indicators displayed within the application (without automated notifications), based on which further clinical management may be determined.
Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data according to instructions provided by their study physician and in accordance with standard care protocols and routine clinical practice. These instructions will be provided at the same time points as those used in the intervention arm, ensuring comparable follow-up throughout the study period. Participants in the control arm will be instructed to adhere consistently to the data collection and self-monitoring procedures until delivery.
Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No aspect of standard care will be withheld from any participant. All participants will continue to receive routine prenatal care and attend scheduled prenatal visits in accordance with established clinical guidelines.
- Conditions
- Hypertensive Disorders of Pregnancy (HDP), Maternal Health Care, Mobile Health Technology (mHealth), Preeclampsia (PE), Pregnancy Hypertension
- Being tested
- mHealth application Penelope, Control
- Keywords
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth application PenelopeOther
Participants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyse a range of health-related data, including self-reported symptoms, blood pressure measurements and proteinuria test results. The application processes data and evaluates the degree of deviation of measured values from normal (note: each value can be on a scale of 1-3, with threshold values for classification as risky defined in collaboration with study physician in accordance with standards of care).
The study physician is alerted to the degree of deviation from normal values in the application by means of color identifiers (not notifications), on the basis of which he or she can decide on further steps.
ControlOther
Control arm will monitor and record their health data following instructions provided by their study
Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data following instructions provided by their study physician in accordance with standard care protocols and the routine clinical practices of their respective healthcare providers. These instructions will be provided at the same time points as in the intervention arm, ensuring that both arms receive comparable follow-up throughout the study period. Control arm participants will be instructed to consistently adhere to the data collection and self-monitoring procedures until delivery. Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No standard care will be withheld by any participant; all participants will continue to attend routine prenatal visits in accordance with established clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Participants in the intervention arm will use the mHealth application daily from gestational week 20 | Experimental | Participants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyse a range of health-related data, including self-reported symptoms, blood pressure measurements and proteinuria test results. The application processes data and evaluates the degree of deviation of measured values from normal (note: each value can be on a scale of 1-3, with threshold values for classification as risky defined in collaboration with study physician in accordance with standards of care). Receives: Other: Control |
| Control arm will monitor and record their health data following instructions provided by their study | Other | Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data following instructions provided by their study physician in accordance with standard care protocols and the routine clinical practices of their respective healthcare providers. These instructions will be provided at the same time points as in the intervention arm, ensuring that both arms receive comparable follow-up throughout the study period. Control arm participants will be instructed to consistently adhere to the data collection and self-monitoring procedures until delivery.
Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No standard care will be withheld by any participant; all participants will continue to attend routine prenatal visits in accordance with established clinical guidelines. Receives: Other: mHealth application Penelope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant.
Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant.
- Includes:
- Direct medical costs (e.g. clinic visits, procedures)
- Digital platform costs (development, maintenance, IT support, amortized per user)
- Indirect non-medical costs (travel, productivity loss, childcare)
Measured: From gestational week 20 until delivery (up to approximately 22 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start6 Oct 2025
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of Pregnancy (HDP)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Principal Engineering s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karel Huml, MD, Principal investigator, Hospital Sumperk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621133
- Sponsor's protocol ID
- Penelope_01_2025
- Other IDs
- 03/2025
- Acronym
- Penelope
- Status last verified
- Sep 2026
- First submitted
- 20 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of an mHealth Application in Pregnancy Care: A Randomized Multi-Center Study Comparing Penelope Users and Non-Users
- ClinicalTrials.gov ID
- NCT07621133
- Acronym / sponsor ID
- Penelope / Penelope_01_2025
- Conditions
- Hypertensive Disorders of Pregnancy (HDP), Maternal Health Care, Mobile Health Technology (mHealth), Preeclampsia (PE), Pregnancy Hypertension
- Keywords
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Principal Engineering s.r.o.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 2 Jun 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.
Participants will be randomly assigned to either the intervention arm (mHealth application users) or the control arm, in which participants will record their data on paper or in Excel according to standard practice or the recommendation of their study physician.
Detailed description
Participants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyze a range of health-related data, including self-reported symptoms, blood pressure measurements, and proteinuria test results. The application processes these data and evaluates the degree of deviation of measured values from predefined normal ranges. Each parameter is assessed on a scale of 1 to 3, with threshold values indicating increased risk established in collaboration with the study physician and in accordance with standards of care.
The study physician is informed of deviations from normal values through color-coded indicators displayed within the application (without automated notifications), based on which further clinical management may be determined.
Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data according to instructions provided by their study physician and in accordance with standard care protocols and routine clinical practice. These instructions will be provided at the same time points as those used in the intervention arm, ensuring comparable follow-up throughout the study period. Participants in the control arm will be instructed to adhere consistently to the data collection and self-monitoring procedures until delivery.
Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No aspect of standard care will be withheld from any participant. All participants will continue to receive routine prenatal care and attend scheduled prenatal visits in accordance with established clinical guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants in the intervention arm will use the mHealth application daily from gestational week 20 | Experimental | Other: ControlParticipants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyse a range of health-related data, including self-reported symptoms, blood pressure measurements and proteinuria test results. The application processes data and evaluates the degree of deviation of measured values from normal (note: each value can be on a scale of 1-3, with threshold values for classification as risky defined in collaboration with study physician in accordance with standards of care). |
| Control arm will monitor and record their health data following instructions provided by their study | Other | Other: mHealth application PenelopeParticipants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data following instructions provided by their study physician in accordance with standard care protocols and the routine clinical practices of their respective healthcare providers. These instructions will be provided at the same time points as in the intervention arm, ensuring that both arms receive comparable follow-up throughout the study period. Control arm participants will be instructed to consistently adhere to the data collection and self-monitoring procedures until delivery. Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No standard care will be withheld by any participant; all participants will continue to attend routine prenatal visits in accordance with established clinical guidelines. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 45 years. Each participant will be enrolled in the study no earlier than the 20th week of pregnancy.
- Pre-gestational hypertension.
- Gestational hypertension.
- Positive screening for preeclampsia.
- The presence of additional secondary risk factors (e.g., controlled type 1 or type 2 diabetes mellitus, obesity with BMI ≥ 30) may be recorded but is not sufficient on its own for inclusion in the study without meeting at least one primary criterion.
Key exclusion criteria (8 listed)
- Uncontrolled diabetes and/or diabetes during the last 3 months prior to enrolment in this study.
- Presence of a gynaecological disease that increases the risk of pregnancy complications, except for those conditions specifically listed in the inclusion criteria (e.g., chronic hypertension, gestational hypertension, pre-gestational hypertension, diabetes mellitus, obesity, or morbid obesity).
- Participant with active malignant disease.
- Participant with alcohol or drug abuse during the recruitment and during the trial course.
- Participant enrolled in another clinical trial during the last 3 months prior to enrolling in this study.
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 |
|---|---|---|
| mHealth application PenelopeParticipants in the intervention arm will use the mHealth application daily from gestational week 20 until delivery. The application will collect and analyse a range of health-related data, including self-reported symptoms, blood pressure measurements and proteinuria test results. The application processes data and evaluates the degree of deviation of measured values from normal (note: each value can be on a scale of 1-3, with threshold values for classification as risky defined in collaboration with study physician in accordance with standards of care). The study physician is alerted to the degree of deviation from normal values in the application by means of color identifiers (not notifications), on the basis of which he or she can decide on further steps. | Other | Control arm will monitor and record their health data following instructions provided by their study |
| ControlControl arm will monitor and record their health data following instructions provided by their study Participants in the control arm will not use the mHealth application. Instead, they will monitor and record their health data following instructions provided by their study physician in accordance with standard care protocols and the routine clinical practices of their respective healthcare providers. These instructions will be provided at the same time points as in the intervention arm, ensuring that both arms receive comparable follow-up throughout the study period. Control arm participants will be instructed to consistently adhere to the data collection and self-monitoring procedures until delivery. Importantly, this is not a medical device study, and the mHealth application is not classified as a medical device. No standard care will be withheld by any participant; all participants will continue to attend routine prenatal visits in accordance with established clinical guidelines. | Other | Participants in the intervention arm will use the mHealth application daily from gestational week 20 |
Primary outcome
Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant.
Time frame: From gestational week 20 until delivery (up to approximately 22 weeks).
Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant. • Includes: * Direct medical costs (e.g. clinic visits, procedures) * Digital platform costs (development, maintenance, IT support, amortized per user) * Indirect non-medical costs (travel, productivity loss, childcare)
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 17 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.
Karel Huml, MD principal investigator
Hospital Sumperk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth application Penelope in people with Hypertensive Disorders of Pregnancy (HDP) and Maternal Health Care, run by Principal Engineering s.r.o. at 1 site in Czechia.
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 6 inclusion and 8 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 17 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 Czechia. 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?
Total cost per completed pregnancy, from both healthcare system and societal perspectives, calculated for each participant. (time frame: From gestational week 20 until delivery (up to approximately 22 weeks).). 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 17 Sep 2026.