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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
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 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.
Hospital Sumperk
Šumperk, Czechia
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)
Time frame: From gestational week 20 until delivery (up to approximately 22 weeks).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
250