Effective support following recurrent pregnancy loss: a randomized controlled feasibility and acceptability study.
Anxiety
Feasibility
Randomized controlled trial
Recurrent pregnancy loss
Journal
Reproductive biomedicine online
ISSN: 1472-6491
Titre abrégé: Reprod Biomed Online
Pays: Netherlands
ID NLM: 101122473
Informations de publication
Date de publication:
May 2020
May 2020
Historique:
received:
07
10
2019
revised:
24
01
2020
accepted:
29
01
2020
entrez:
24
5
2020
pubmed:
24
5
2020
medline:
13
4
2021
Statut:
ppublish
Résumé
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? 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. 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. 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.
Identifiants
pubmed: 32444166
pii: S1472-6483(20)30077-8
doi: 10.1016/j.rbmo.2020.01.022
pii:
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
729-742Informations de copyright
Copyright © 2020 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.