Screening for Postpartum Depression Using EPDS and HAM-D in Mothers Within 72 Hours After Delivery at a Tertiary Care Center (SOS-Mamma Study)

Postpartum depression (PPD) is one of the most common complications affecting maternal mental health after childbirth, with an estimated prevalence of 10-20% in high-income countries. Despite its frequency and the availability of effective screening tools, early diagnosis remains largely underestimated in routine clinical care. This study, part of the national SOS-Mamma project funded by the Italian Ministry of Health, aims to systematically screen for signs of postpartum depression in women giving birth at a tertiary care obstetric unit (AOU Vanvitelli - UOC of Obstetrics and Gynecology, Naples, Italy). The goal is to promote early detection and timely referral to specialized care pathways. The study is a prospective, observational, monocentric, non-interventional, non-pharmacological study. All eligible women who deliver at the hospital will be invited to participate within the first 72 hours after childbirth. Participants will be asked to complete the Edinburgh Postnatal Depression Scale (EPDS) - a widely used self-report questionnaire - and will undergo a brief clinical interview using the Hamilton Depression Rating Scale (HAM-D), conducted by trained healthcare staff. The study's primary objective is to estimate the real-world incidence of postpartum depression within this population. Secondary objectives include identifying socio-demographic and obstetric risk factors associated with depressive symptoms, assessing the acceptability and feasibility of routine screening, and contributing to the development of a replicable model of care aligned with international recommendations (NICE, WHO, ISS). Collected data will be anonymized and analyzed to provide evidence on early indicators of PPD and guide improvements in clinical care. Women identified as being at risk (e.g., EPDS \>10 or presence of suicidal ideation) will be referred to specialist psychiatric services in accordance with clinical guidelines. Participation in the study is voluntary. All procedures comply with European data protection regulations and Good Clinical Practice (GCP) principles. No experimental treatments are involved, and no changes to standard care will be made based on study participation. By highlighting the need for structured mental health screening in the postpartum period, this study hopes to improve maternal wellbeing and reduce the long-term impact of undiagnosed depression on mothers and their children.

NCT Number	NCT07025902
Lead Sponsor	University of Campania Luigi Vanvitelli
Conditions	Post Partum Depression
Enrollment	273 participants
Start Date	2025-07-15
Primary Completion	2026-07-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-18