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Life sciences · Observational Study
ClinicalTrials.gov · November 5, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07918365). This is a study registration, not published results. Lead sponsor: Centre Hospitalier Universitaire de Besancon. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Depression Disorder, Post Traumatic Stress Disorder PTSD. Primary outcome measures: Childbirth related post-traumatic stress disorder , November 2026 to May 2027. Brief summary: In France, perinatal mental health has become a major public health issue. Maternal mental health conditions can have serious consequences, including death by suicide. Fathers may also experience significant psychological distress during the perinatal period. These difficulties can affect parents' well-being, the developing parent-infant relationship, and family life, highlighting the importance of early identification and appropriate support for both parents. The birth of an infant before 28 completed weeks of gestation can be a traumatic experience for parents. Concerns about the infant's survival and health, together with the unfamiliar environment of a neonatal intensive care unit, can disrupt the transition to parenthood and may be associated with severe depressive symptoms and childbirth-related post-traumatic stress symptoms. This single-centre observational study explores the psychological experiences of couples following the birth of an infant before 28 completed weeks of gestation. Its primary objective is to assess childbirth-related post-traumatic stress symptoms using the City Birth Trauma Scale. Secondary objectives are to assess depressive symptoms and explore parental representations, emotional experiences, and psychological functioning. Couples will be invited to participate during their infant's hospitalisation in the neonatal intensive care unit at Besançon University Hospital, France. Both parents in each couple will participate, with individual assessments taking place at least one month after birth. Each assessment session will last approximately 90 minutes and will include a semi-structured interview using the Clinical Interview for Parents of High-Risk Infants (CLIP), the Rorschach test, and two self-report questionnaires: the Edinburgh Postnatal Depression Scale (EPDS) and the City Birth Trauma Scale, using the appropriate maternal or partner version. This exploratory study aims to improve understanding of parental psychological vulnerability following extremely preterm birth. In the longer term, its findings may raise healthcare professionals' awareness of maternal and paternal distress and inform approaches to systematic screening for postnatal depression and childbirth-related post-traumatic stress symptoms. Ultimately, this research seeks to support the development of care that addresses both parents' psychological needs and promotes early parent-infant relationships.