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 | Not Yet Recruiting

• 1 other identifier: 0017100/i
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Post Partum Depression; EPDS; HAM-D Scales

Outcome Measures

Primary Outcomes (2)

• Incidence of postpartum depression assessed by EPDS

  Incidence of postpartum depression assessed by EPDS The proportion of postpartum women who screen positive for depressive symptoms within 72 hours after delivery, based on the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item self-report questionnaire, and a score ≥10 is considered indicative of clinically relevant depressive symptoms.

  Within 72 hours postpartum during routine hospital stay following delivery

• Incidence of postpartum depression assessed by HAM-D

  The proportion of postpartum women who screen positive for depressive symptoms within 72 hours after delivery, based on the Hamilton Depression Rating Scale (HAM-D). This clinician-administered scale assesses severity of depression; established cutoff scores will be used to classify presence of depressive symptoms.

  Within 72 hours postpartum during routine hospital stay following delivery

Study Arms (1)

Postpartum Women Screened Within 72 Hours After Delivery

This cohort consists of postpartum women who deliver a live-born infant at ≥35 weeks of gestation and are clinically stable. Participants are screened within 72 hours after childbirth using the Edinburgh Postnatal Depression Scale (EPDS) and the Hamilton Depression Rating Scale (HAM-D). The study includes both women with and without depressive symptoms, allowing comparison within the cohort based on screening results. The purpose is to assess the incidence of postpartum depression and identify associated socio-demographic or obstetric risk factors in a real-world clinical setting

Diagnostic Test: Standardized Psychological Screening Using EPDS and HAM-D

Interventions

Standardized Psychological Screening Using EPDS and HAM-D DIAGNOSTIC_TEST

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.

Postpartum Women Screened Within 72 Hours After Delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility is restricted to biological females who have recently delivered a live-born infant. The study targets postpartum women within 72 hours after childbirth in order to assess early depressive symptoms related to the perinatal period. Individuals identifying as women but not having given birth are not eligible. Gender-based eligibility is therefore directly related to the biological and clinical characteristics of postpartum status, which is central to the study objectives.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consists of postpartum women who deliver at the AOU Vanvitelli - UOC of Obstetrics and Gynecology, a tertiary care academic hospital in Naples, Italy. This is a real-world clinical population composed primarily of women receiving routine obstetric care through the Italian National Health System. The cohort includes patients with both physiological and low-risk obstetric complications. Participants will be recruited during their standard postpartum hospital stay, within 72 hours after delivery.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Largo Madonna delle grazie 1

Naples, 80138, Italy

Location

Related Publications (1)

• Luciano M, Di Vincenzo M, Brandi C, Tretola L, Toricco R, Perris F, Volpicelli A, Torella M, La Verde M, Fiorillo A, Sampogna G. Does antenatal depression predict post-partum depression and obstetric complications? Results from a longitudinal, long-term, real-world study. Front Psychiatry. 2022 Dec 14;13:1082762. doi: 10.3389/fpsyt.2022.1082762. eCollection 2022.

  PMID: 36590632 RESULT

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Marco La Verde, MD, researcher, PhD student

CONTACT

+393389412266; marco.laverde@unicampania.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., researcher and PhD student

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 18, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)