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

NCT07025902 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 273

Last updated 2025-06-18

No results posted yet for this study

Summary

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.

Conditions

  • Post Partum Depression

Interventions

DIAGNOSTIC_TEST

Standardized Psychological Screening Using EPDS and HAM-D

Participants will undergo a standardized psychological screening protocol for postpartum depression within 72 hours after delivery. The protocol includes: (1) completion of the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-administered questionnaire assessing depressive symptoms; and (2) administration of the Hamilton Depression Rating Scale (HAM-D), a 17-item clinician-administered tool for evaluating the severity of depressive symptoms. The combined use of these tools allows early detection and stratification of postpartum depressive symptoms in a clinical population.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-07-01
Completion
2027-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07025902 on ClinicalTrials.gov