A feasibility and acceptability study and a qualitative process evaluation of a coping intervention for recurrent miscarriage

Abstract

Background: Recurrent miscarriage is diagnosed when a woman has had three or more consecutive miscarriages. Increased levels of distress and anxiety are common during the early stages of any subsequent pregnancies, as women affected by this condition wait for confirmation that their pregnancy is ongoing. This can pose a significant threat to their psychological well-being, however only limited support and therapy are available. The Positive Reappraisal Coping Intervention (PRCI) is a novel self-administered supportive technique that has been shown to be effective in patients awaiting the outcome of fertility treatment.

Study objectives: The primary objective of this study was to assess the feasibility of running a future definitive study to test the effectiveness of the PRCI in improving quality of life in the difficult waiting period that women with previous miscarriage endure before an ongoing pregnancy can be confirmed.

Methodology: A two-centre randomised controlled trial feasibility study and qualitative process evaluation recruited seventy-six participants. Forty-seven of these were randomised at the point of a positive pregnancy test in to one of two study groups. The PRCI intervention group received the PRCI card and weekly questionnaires to assess their psychological well-being during the waiting period of their new pregnancy. The non-intervention group completed the same weekly questionnaires. The qualitative process evaluation employed semi-structured interviews (n=14) to address relevant aspects of the study objectives.

Feasibility findings: Data suggest that successful recruitment to a future definitive study investigating a coping intervention for recurrent miscarriage is possible and that there is an appropriate and sizeable patient population willing to take part. The study participants demonstrated a positive attitude to using the PRCI, finding it an acceptable and practical intervention to use during the challenging waiting period of a new pregnancy. Results are encouraging and demonstrate that use of the PRCI was popular and conveyed some benefits to participants. An effectiveness RCT is warranted, however with some modification to take into account feasibility findings including varying recruitment rates between study sites, the reactive effect of Weekly Record Keeping data collection questionnaire and the adaptation of the use of the PRCI.

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Identifiers

ORCID for Ellen Kitson-Reynolds: orcid.org/0000-0002-8099-883X

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