Cost-Effectiveness of an mHealth Application in Pregnancy Care

NCT07621133 | Active Not Recruiting

• 2 other identifiers: Penelope_01_202503/2025
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertensive Disorders of Pregnancy (HDP); Maternal Health Care; Mobile Health Technology (mHealth); Preeclampsia (PE); Pregnancy Hypertension

Keywords

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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)

  From gestational week 20 until delivery (up to approximately 22 weeks).

Study Arms (2)

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).

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.

Other: mHealth application Penelope

Interventions

mHealth application Penelope OTHER

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.

Control arm will monitor and record their health data following instructions provided by their study

Control OTHER

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.

Participants in the intervention arm will use the mHealth application daily from gestational week 20

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled diabetes and/or diabetes during the last 3 months prior to enrolment in this study.
• 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.

Sponsors & Collaborators

• Principal Engineering s.r.o.: lead

Study Sites (1)

Hospital Sumperk

Šumperk, Czechia

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karel Huml, MD

  Hospital Sumperk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 2, 2026
• Study Start: October 6, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)