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Life sciences · Interventional Study
ClinicalTrials.gov · October 27, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07898176). This is a study registration, not published results. Lead sponsor: University of Seville. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Depressive Symptoms, Perinatal Loss, Perinatal Grief, Anxiety Symptoms. Interventions: BEHAVIORAL: e-Perinatal Butterfly; OTHER: Standard routine maternal care. Primary outcome measures: Feasibility of the intervention , Measured at enrollment and postintervention (3 months after enrollment); Early acceptability , Measured at enrollment; Final acceptability , Measured at postintervention (3 months after enrollment). Brief summary: This study is part of the e-Perinatal project and is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008). No additional randomization is performed for this embedded study. Women participating in the parent trial who experience early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, together with their participating partners, are eligible for this study. Participants retain the study-group allocation assigned to their primary healthcare center in the parent trial. Participants from clusters allocated to the intervention arm are offered access to the e-Perinatal Butterfly web-app as a complementary component of the e-Perinatal intervention. The e-Perinatal Butterfly web-app provides tailored psychoeducational resources and digital support tools for parents experiencing perinatal bereavement. Participants from clusters allocated to the control arm continue to receive usual care. The primary objectives are to assess the feasibility and acceptability of the e-Perinatal Butterfly intervention. The study will also explore changes in symptoms of depression and anxiety among parents who have experienced a perinatal loss. Secondary exploratory analyses will examine longitudinal trajectories of depression and anxiety among bereaved participants and compare these trajectories between the intervention and control arms and with those observed in the broader cohort of the parent e-Perinatal trial