Psychological STress, Anxiety, and Depression After miscarriage in comparison to successful pregnancy and abortion: design and protocol for the observational cohort study STRADA

Introduction Miscarriage occurs in 15%–20% of clinically recognised pregnancies. It may cause acute or prolonged psychological distress such as anxiety, depression and post-traumatic stress disorder (PTSD). Data on symptom severity and duration after miscarriage are limited. This study assesses the prevalence, severity, risk and protective factors of acute and prolonged psychological symptoms as well as the impact of prolonged distress on future general and reproductive health. Methods and analysis This prospective observational cohort study enrols patients and partners at the time of miscarriage diagnosis. As controls, we enrol patients with spontaneous or assisted reproductive technology (ART)-conceived ongoing pregnancies and patients requesting induced abortion. Participants complete validated questionnaires within 1 week after enrolment, and at 3 and 9 months. The primary objective is to study the prevalence and severity of acute and prolonged psychological symptoms, including anxiety, depression and PTSD, to determine the need for psychological support. Secondary objectives include studying the effects of patient characteristics, socioeconomic background and previous physical and psychiatric health on symptom persistence and possible effects on subsequent pregnancies. Information is collected both through prospective self-reported questionnaires and retrospectively through national registries. A voluntary blood sample at enrolment is collected to search for endocrine, metabolic, inflammatory and genetic markers involved in miscarriage and psychiatric morbidity. Based on power calculations we plan to enrol 439 patients in the miscarriage and ongoing pregnancy groups and 220 patients in the induced abortion and ART groups. Partners are invited to participate. Ethics and dissemination The study will be performed in accordance with ethical principles consistent with the Declaration of Helsinki, ICH/GCPE6 (R2), European Union Clinical Trials Directive and applicable local regulatory requirements. The study has received approval from the ethics committee of the Helsinki University Hospital and from the Helsinki University Hospital. A collaborative agreement with the Helsinki Biobank has been made for depositing blood samples. The results of this study will be disseminated via publication in peer-reviewed journals.