NCT06442774 MamaConecta: Digital Tool for Maternal Mental Health
| NCT ID | NCT06442774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | A Thousand Colibris, S.L |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2024-12-28 |
| Primary Completion | 2025-11-01 |
Trial Parameters
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Brief Summary
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are: * Does the app improve overall maternal well-being during the perinatal period? * Can the app increase the early detection rates of perinatal mental health disorders? * Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems? * How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants? Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes. Participants will: * Use the mobile application from 12-14 weeks of gestation until 24 months postpartum. * Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data. * Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old. This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.
Eligibility Criteria
Inclusion Criteria: * Gestational age between 12-14 weeks of gestation. * The first obstetric ultrasound has been performed. * Women who know how to read and understand Spanish. * Women who have access to a mobile phone with an internet connection (data or wifi) * Women who have knowledge of technology tools via app. * Have signed the informed consent to participate in the study. Exclusion Criteria: * Termination of pregnancy, or early miscarriage * Perinatal loss at any time during pregnancy. * Severe mental pathology or moderate unstable mental pathology. * Consumption of toxic substances.