Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-31 @ 11:38 PM
Study NCT ID:
NCT07025902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-18
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Postpartum Depression Using EPDS and HAM-D in Mothers Within 72 Hours After Delivery at a Tertiary Care Center (SOS-Mamma Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 273}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postpartum depression assessed by EPDS', 'timeFrame': 'Within 72 hours postpartum during routine hospital stay following delivery', 'description': '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.'}, {'measure': 'Incidence of postpartum depression assessed by HAM-D', 'timeFrame': 'Within 72 hours postpartum during routine hospital stay following delivery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post Partum Depression', 'EPDS', 'HAM-D Scales'], 'conditions': ['Post Partum Depression']}, 'referencesModule': {'references': [{'pmid': '36590632', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe 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.\n\nThe 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).\n\nCollected 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.\n\nParticipation 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.\n\nBy 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.", 'detailedDescription': '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.\n\nThe 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.\n\nScreening Protocol\n\nWithin 72 hours after delivery, enrolled participants will undergo a standardized two-step screening process for depressive symptoms:\n\nEdinburgh Postnatal Depression Scale (EPDS): a validated self-administered questionnaire assessing depressive symptoms over the previous two weeks.\n\nHamilton Depression Rating Scale (HAM-D): a clinician-administered scale evaluating the severity of depressive symptoms via a 17-item structured interview.\n\nClinical, 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.\n\nPrimary 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.\n\nSecondary Objectives To identify clinical and socio-demographic risk factors associated with depressive symptoms.\n\nTo assess the feasibility and acceptability of implementing a systematic screening protocol in postpartum care.\n\nTo generate evidence for a scalable model of early detection and referral for maternal mental health disorders in accordance with international guidelines (NICE, WHO, ISS).\n\nSample 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.\n\nData 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.\n\nQuality Assurance and Data Management Data anonymization will be implemented immediately after collection using a study-specific alphanumeric code.\n\nData will be stored in a secure, password-protected electronic database accessible only to authorized research personnel.\n\nData quality control will include double entry checks, logic checks for consistency and range, and periodic review by the Principal Investigator.\n\nThe study team will follow Standard Operating Procedures (SOPs) for recruitment, informed consent, questionnaire administration, data recording, and adverse event documentation.\n\nAll research staff involved in data collection and screening will be trained in Good Clinical Practice (GCP) and use of the screening instruments.\n\nAdverse events (including psychological distress triggered by the screening process) will be recorded, reported, and referred to psychiatric evaluation per protocol.\n\nHandling 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.\n\nEthical 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.\n\nDissemination 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'nclusion Criteria\n\nWomen aged ≥18 and \\<45 years at the time of delivery\n\nSingleton pregnancy at term (≥37 weeks) or late preterm (≥35 weeks of gestation)\n\nLive-born infant in clinically stable condition at discharge\n\nAbility to understand and complete self-reported questionnaires (EPDS) in Italian or English\n\nAbility to provide written informed consent\n\nScreening performed within 72 hours postpartum during routine hospital stay\n\nExclusion Criteria\n\nMultiple pregnancy (e.g., twins or higher-order gestations)\n\nMajor psychiatric diagnosis under active treatment at the time of delivery (e.g., schizophrenia, bipolar disorder)\n\nSevere language barriers preventing adequate understanding of the consent form or questionnaires\n\nNeonatal death or congenital anomalies requiring prolonged NICU admission\n\nMaternal age \\<18 or ≥45 years at delivery\n\nGestational age at birth \\<35 weeks'}, 'identificationModule': {'nctId': 'NCT07025902', 'acronym': 'SOS-Mamma', 'briefTitle': 'Screening for Postpartum Depression Using EPDS and HAM-D in Mothers Within 72 Hours After Delivery at a Tertiary Care Center (SOS-Mamma Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Holistic Support Pathways for Maternal Psychological Wellbeing: A Comprehensive Approach From Preconception to Postpartum (SOS-Mamma).', 'orgStudyIdInfo': {'id': '0017100/i'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postpartum Women Screened Within 72 Hours After Delivery', 'description': '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', 'interventionNames': ['Diagnostic Test: Standardized Psychological Screening Using EPDS and HAM-D']}], 'interventions': [{'name': 'Standardized Psychological Screening Using EPDS and HAM-D', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Postpartum Women Screened Within 72 Hours After Delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Naples', 'country': 'Italy', 'contacts': [{'name': 'Marco La Verde, MD, researcher, PhD student', 'role': 'CONTACT', 'email': 'marco.laverde@unicampania.it', 'phone': '+393389412266', 'phoneExt': '+39'}], 'facility': 'Largo Madonna delle grazie 1', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Marco La Verde, MD, researcher, PhD student', 'role': 'CONTACT', 'email': 'marco.laverde@unicampania.it', 'phone': '+393389412266', 'phoneExt': '+39'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared with other researchers. The informed consent form signed by participants does not include provisions for data sharing outside the study team. Additionally, due to the sensitive nature of mental health data and the single-site observational design, sharing of IPD is not planned in order to ensure full compliance with ethical and data protection regulations (including GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., researcher and PhD student', 'investigatorFullName': 'Marco La Verde', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}