Psychological impact of early miscarriage and client satisfaction with treatment : a comparison between expectant management and misoprostol treatment in a randomized controlled trial

OBJECTIVES: To compare short- and long-term emotional distress (grief, anxiety, depressive symptoms) after early miscarriage in women randomized to expectant management or misoprostol treatment, and to compare satisfaction with treatment. METHODS: This is a randomized controlled trial (ClinicalTrials.gov ID: NCT01033903) comparing expectant management with misoprostol treatment of early miscarriage. If the miscarriage was not complete on day 31 after inclusion surgical evacuation was recommended. Main outcome measures were grief, anxiety, depressive symptoms and client satisfaction assessed by validated psychometric self-assessment instruments, i.e. Perinatal grief scale (PGS), Spielberger State-Trait Anxiety Inventory (STAI-S Form-Y), Montgomery-åsberg Depression Rating Scale Self-report version (MADRS-S) and Client Satisfaction Questionnaire (CSQ-8). There were four assessment points: the day of randomization, the day when the miscarriage was judged to be complete, and 3 months and 14 months after complete miscarriage. Analysis was by intention to treat. RESULTS: 90 women were randomized to expectant management and 94 to misoprostol treatment. The psychometric and client satisfaction scores were similar in the two treatment groups at all assessment points. At inclusion, 41% (35/86) of the women managed expectantly and 37% (34/92) of those treated with misoprostol had STAI-state scores >46 ("high levels of anxiety") and 9% (8/86) and 10% (9/91) had symptoms of moderate or severe depression (MADRS-S score >20). In both treatment groups, symptom scores for anxiety and depression were significantly higher at inclusion than after treatment and remained low until 14 months after complete miscarriage. Grief reactions were mild. The median PGS score in both treatment groups was 40.0 at 3 months and 37.0 at 14 months after complete miscarriage. Four women treated with misoprostol and two women managed expectantly had PGS scores >90 (indicating deep grief) 3 months after complete miscarriage. One woman managed expectantly had PGS score >90 after 14 months. More than 85% of the participants in both groups would recommend the treatment they received to a friend. CONCLUSIONS: The psychological response to and recovery after early miscarriage did not differ between women treated with misoprostol and those managed expectantly. Satisfaction with treatment was high in both treatment groups. Our findings support patient involvement when deciding on management of early miscarriage. This article is protected by copyright. All rights reserved