Evaluating the effectiveness of a web-based intervention to promote mental wellbeing in women and partners following miscarriage, using a modified patient preference trial design: an external pilot.

This article describes an external pilot study of a modified 'partially randomised patient preference' trial comparing a web-based intervention (designed to promote mental wellbeing) with standard care post-miscarriage. Assessment comprised an online administration of baseline measures with follow-up at 3 months following registration. Baseline data were obtained from 60 women (and seven partners) post-discharge from one of two Early Pregnancy Assessment Units. 'Intention to treat' versus a 'per protocol' sensitivity analysis showed the effects of introducing a 'preference' option post-randomisation, and highlights the benefits compared with a randomised controlled trial design to enable a robust evaluation of the website in promoting mental wellbeing after miscarriage.

The emotional burden of miscarriage for women and their partners: trajectories of anxiety and depression over 13 months.

OBJECTIVE: To identify the trajectories of anxiety and depression in women and in their partners over 13 months after miscarriage. DESIGN: A prospective study with follow up at 6 and 13 months after miscarriage. SETTING: Three Scottish Early Pregnancy Assessment Units. SAMPLE: Of the 1443 eligible individuals approached, 686 (48.3%) consented to participate (432 women; 254 men). Complete data were obtained from 273 women and 133 men at baseline, 6, and 13 months. METHODS: On completion of the management of the index miscarriage, eligible and consenting women and men underwent an initial assessment comprising a semi-structured interview and a standardised self-report questionnaire. The latter was readministered at the follow-up assessments. MAIN OUTCOME MEASURES: The hospital anxiety and depression scale (HADS), a reliable and valid measure of general psychopathology for use in nonpsychiatric samples. RESULTS: Compared with depression, anxiety was overall the greater clinical burden. Over the 13-month period, women reported higher levels of anxiety and depression than men. Over time, a significantly greater level of adjustment was reported by women particularly with regards to the resolution of anxiety symptoms. The effect of time on HADS scores in either gender was similar between subgroups of socio-demographic and clinical factors. CONCLUSIONS: These findings verify that early pregnancy loss represents a significant emotional burden for women, and to some extent for men, especially with regards to anxiety. For many, the detrimental effects of miscarriage are enduring and display a complex course of resolution. These findings are discussed in terms of their clinical implications for early identification and management.