Effective support following recurrent pregnancy loss: A randomized controlled feasibility and acceptability study

Research Question Is it feasible to perform a future definitive trial to determine the effectiveness of the Positive Reappraisal Coping Intervention (PRCI) in improving the psychological well-being of women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy? Design This mixed method study aimed to establish the feasibility of conducting a multicentre randomised controlled trial (RCT) to definitively test the effects of the PRCI on the psychological well-being of women with RPL. Participants (n=75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomised into two study groups. The intervention group received the PRCI and weekly questionnaire assessment (Hospital Anxiety Depression Scale and Weekly Record Keeping Form) to monitor psychological well-being, the control group received the same questionnaires. Nested within the RCT was a qualitative process evaluation (QPE) exploring participants’ subjective experience of study methods and the intervention. The study was conducted over a two-year period between 2014 and 2016 Results This study successfully gathered knowledge about the feasibility aspects of conducting a future multi-centre definitive study to determine the effects of the PRCI on the psychological well-being of women with RPL. Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside. Conclusions The study concluded that a definitive RCT of the PRCI is possible and that the model of care already has the potential to be made more widely available as a safe, low cost, convenient and easily deliverable intervention to provide much needed support to a vulnerable patient population