This clinical study is part of the national project SOS-Mamma ("Holistic Support Pathways for Maternal Psychological Wellbeing"), funded by the Italian Ministry of Health (Programma CCM 2024). The present protocol outlines a prospective, observational, monocentric, non-pharmacological, non-interventional study, aiming to estimate the incidence of postpartum depression (PPD) and evaluate the clinical feasibility of implementing a standardized screening protocol in a real-life maternity care setting.
The study is conducted at a tertiary-level obstetric and gynecologic unit (AOU Vanvitelli - UOC of Obstetrics and Gynecology, Naples, Italy), over a planned recruitment period of 24 months. Eligible participants include women delivering live-born infants at ≥35 weeks of gestation, who are clinically stable, able to consent, and able to complete the questionnaires in Italian or English.
Screening Protocol
Within 72 hours after delivery, enrolled participants will undergo a standardized two-step screening process for depressive symptoms:
Edinburgh Postnatal Depression Scale (EPDS): a validated self-administered questionnaire assessing depressive symptoms over the previous two weeks.
Hamilton Depression Rating Scale (HAM-D): a clinician-administered scale evaluating the severity of depressive symptoms via a 17-item structured interview.
Clinical, socio-demographic, and obstetric data will be collected from medical records and patient interviews, including maternal age, parity, education level, marital status, occupational status, pregnancy complications, delivery mode, neonatal outcomes (e.g., Apgar score, NICU admission), and psychiatric history.
Primary Objective To estimate the incidence of postpartum depression within 72 hours postpartum using validated screening instruments (EPDS and HAM-D) in a real-world clinical population.
Secondary Objectives To identify clinical and socio-demographic risk factors associated with depressive symptoms.
To assess the feasibility and acceptability of implementing a systematic screening protocol in postpartum care.
To generate evidence for a scalable model of early detection and referral for maternal mental health disorders in accordance with international guidelines (NICE, WHO, ISS).
Sample Size and Statistical Considerations Based on previous epidemiological data (expected prevalence of PPD \~19% in the local population), a sample size of at least 273 women is calculated to detect ≥53 cases of postpartum depression, with an alpha of 0.05 and statistical power \>80%. This sample will allow for robust estimation of incidence and risk factor associations.
Data analysis will include descriptive statistics, bivariate comparisons (e.g., chi-square test, t-test, Mann-Whitney U), and multivariate logistic regression models to identify independent predictors of depressive symptoms. The software MedCalc (v23.2.1) will be used for all analyses.
Quality Assurance and Data Management Data anonymization will be implemented immediately after collection using a study-specific alphanumeric code.
Data will be stored in a secure, password-protected electronic database accessible only to authorized research personnel.
Data quality control will include double entry checks, logic checks for consistency and range, and periodic review by the Principal Investigator.
The study team will follow Standard Operating Procedures (SOPs) for recruitment, informed consent, questionnaire administration, data recording, and adverse event documentation.
All research staff involved in data collection and screening will be trained in Good Clinical Practice (GCP) and use of the screening instruments.
Adverse events (including psychological distress triggered by the screening process) will be recorded, reported, and referred to psychiatric evaluation per protocol.
Handling of Missing Data In case of missing, inconsistent, or uninterpretable data, predefined coding will be used to distinguish between non-response, refusal, technical error, or medical unsuitability. Missing data will be analyzed descriptively and handled via appropriate imputation or exclusion methods depending on their frequency and pattern.
Ethical and Regulatory Compliance This study will be conducted in accordance with the Declaration of Helsinki, GCP, GDPR (EU Regulation 2016/679), and applicable national laws. Ethical approval has been requested from the competent ethics committee, and informed consent will be obtained from all participants.
Dissemination and Transparency Findings will be submitted for peer-reviewed publication and presented at scientific conferences, irrespective of the outcome. The dataset may be made available for secondary analysis upon justified request, following ethical and regulatory approval.
