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 randomized 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 randomized into two study groups. The intervention group received the PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) 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 multicentre 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.

Anxiety, Feasibility, Randomized controlled trial, Recurrent pregnancy loss

10.1016/j.rbmo.2020.01.022

1472-6483

729-742

Bailey, Sarah

3c7e9f3c-8713-4e9e-90af-e8f9174c8e47

Boivin, Jacky

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Cheong, Ying

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Bailey, Christopher D

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Kitson-Reynolds, Ellen

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Macklon, Nicholas

7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e

May 2020

Bailey, Sarah

3c7e9f3c-8713-4e9e-90af-e8f9174c8e47

Boivin, Jacky

635abacc-1b16-4280-ba4b-9ec691d9094a

Cheong, Ying

4efbba2a-3036-4dce-82f1-8b4017952c83

Bailey, Christopher D

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Kitson-Reynolds, Ellen

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Macklon, Nicholas

7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e

Bailey, Sarah, Boivin, Jacky, Cheong, Ying, Bailey, Christopher D, Kitson-Reynolds, Ellen and Macklon, Nicholas (2020) Effective support following recurrent pregnancy loss: a randomized controlled feasibility and acceptability study. Reproductive BioMedicine Online, 40 (5), 729-742. (doi:10.1016/j.rbmo.2020.01.022).

Record type: Article

Abstract

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The Positive Reappraisal Coping Intervention a randomised controlled trial of a supportive intervention for women with recurrent pregnancy loss - Accepted Manuscript

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Effective support following recurrent pregnancy loss a randomized controlled feasibility and acceptability study. - Accepted Manuscript

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Table 1 - Baseline demographics final