NCT07621133Completed
Cost-Effectiveness of an mHealth Application in Pregnancy Care
Cost-Effectiveness of an mHealth Application in Pregnancy Care: A Randomized Multi-Center Study Comparing Penelope Users and Non-Users
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 166 (actual)
- First submitted
- 20 May 2026
- Start date
- 6 Oct 2025
- Primary completion date
- 18 Aug 2026
- Lead sponsor
- Principal Engineering s.r.o.
- Diseases
- High blood pressure
- NCT number
- NCT07621133
What you commit to
- Study type: Interventional
- Participants enrolled: 166
- From 6 Oct 2025 to the primary completion date, 18 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled diabetes and/or diabetes during the last 3 months prior to enrolment in this study.
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Sumperk Coordinator of this site? Confirm its status | Šumperk | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.