Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT07025902
Eligibility Criteria:
nclusion Criteria
Women aged ≥18 and \<45 years at the time of delivery
Singleton pregnancy at term (≥37 weeks) or late preterm (≥35 weeks of gestation)
Live-born infant in clinically stable condition at discharge
Ability to understand and complete self-reported questionnaires (EPDS) in Italian or English
Ability to provide written informed consent
Screening performed within 72 hours postpartum during routine hospital stay
Exclusion Criteria
Multiple pregnancy (e.g., twins or higher-order gestations)
Major psychiatric diagnosis under active treatment at the time of delivery (e.g., schizophrenia, bipolar disorder)
Severe language barriers preventing adequate understanding of the consent form or questionnaires
Neonatal death or congenital anomalies requiring prolonged NICU admission
Maternal age \<18 or ≥45 years at delivery
Gestational age at birth \<35 weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07025902
Study Brief:
Protocol Section:
NCT07025902