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

Effective support following recurrent pregnancy loss a randomized controlled feasibility and acceptability study
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
1472-6483
729-742
Bailey, Sarah
3c7e9f3c-8713-4e9e-90af-e8f9174c8e47
Boivin, Jacky
635abacc-1b16-4280-ba4b-9ec691d9094a
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Bailey, Christopher D
af803055-3a2d-42cf-813c-47558ca0a3e5
Kitson-Reynolds, Ellen
28b0a1aa-6f3c-4fed-bf0a-456fe5f5ca73
Macklon, Nicholas
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
Bailey, Sarah
3c7e9f3c-8713-4e9e-90af-e8f9174c8e47
Boivin, Jacky
635abacc-1b16-4280-ba4b-9ec691d9094a
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Bailey, Christopher D
af803055-3a2d-42cf-813c-47558ca0a3e5
Kitson-Reynolds, Ellen
28b0a1aa-6f3c-4fed-bf0a-456fe5f5ca73
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

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.

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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
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Table 2 - Sample characteristics of participants of QPE final
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Table 3 - Corrected Key feasibility findings final
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Figure 1 - The Positive Reappraisal Coping Intervention
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Figure 2 - CONSORT diagram final
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Figure 3 QPE interview extracts - final
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Figure 4 Frequency of use of PRCI_final
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Figure 5 - HADS mean scores for anxiety final
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More information

Accepted/In Press date: 29 January 2020
e-pub ahead of print date: 5 February 2020
Published date: May 2020
Keywords: Anxiety, Feasibility, Randomized controlled trial, Recurrent pregnancy loss

Identifiers

Local EPrints ID: 440967
URI: http://eprints.soton.ac.uk/id/eprint/440967
ISSN: 1472-6483
PURE UUID: ff2e085d-b025-403b-90c9-9857080ca843
ORCID for Ying Cheong: ORCID iD orcid.org/0000-0001-7687-4597
ORCID for Christopher D Bailey: ORCID iD orcid.org/0000-0002-7528-6264
ORCID for Ellen Kitson-Reynolds: ORCID iD orcid.org/0000-0002-8099-883X

Catalogue record

Date deposited: 26 May 2020 16:31
Last modified: 26 Nov 2021 06:15

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Contributors

Author: Sarah Bailey
Author: Jacky Boivin
Author: Ying Cheong ORCID iD
Author: Christopher D Bailey ORCID iD
Author: Nicholas Macklon

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