Cost-Effectiveness of an mHealth Application in Pregnancy Care

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

Interventions

OTHER

mHealth application Penelope

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.

OTHER

Control

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.

Sponsors & Collaborators

• Principal Engineering s.r.o.

  lead INDUSTRY

Principal Investigators

• Karel Huml, MD · Hospital Sumperk

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-06

Primary Completion

2026-08-15

Completion

2026-09-30

Countries

• Czechia

Study Locations