title: A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage.
abstract: BACKGROUND
  Recurrent miscarriage (RM) is diagnosed when a woman has had three or more miscarriages. Increased levels of distress and anxiety are common during the waiting period of any subsequent pregnancies, posing a significant threat to psychological well-being. However, only limited support and therapy are available for these women, and many are left to cope alone. The Positive Reappraisal Coping Intervention (PRCI) is a novel self-administered supportive technique which has been shown to be effective in patients awaiting the outcome of in vitro fertilisation treatment. The primary objective of this study is to assess the feasibility and effectiveness of the PRCI in improving quality of life in the difficult waiting period which women with previous RM endure before an ongoing pregnancy can be confirmed.
  
  
  METHODS
  A randomised controlled trial (RCT) feasibility study will establish the viability of conducting a multicentre RCT to definitively test the effects of the PRCI on the psychological well-being of women who have experienced RM during the initial waiting period of a subsequent pregnancy. A second component consists of a qualitative process evaluation exploring the initial experience of pregnancy following repeated miscarriages. Participants (n=50) will be randomised into one of two groups. The PRCI intervention group will receive the PRCI card and weekly questionnaires to assess their psychological well-being during the waiting period of their new pregnancy. The non-intervention group will be asked to complete the same weekly questionnaires. The qualitative process analysis will employ semistructured interviews (n=20) to address relevant aspects of the study objectives.
  
  
  BACKGROUND
  Ethics approval has been obtained from the National Research Ethics Service Committee South Central-Hampshire A. Participating centres have given National Health Service R&D approval. Study findings will be disseminated through peer reviewed journals, national and international conferences and lay user groups.
  
  
  BACKGROUND
  ISRCTN43571276. This study was registered with the ISRCTN 18/02/2014 following adoption onto the United Kingdom Clinical Research Network (UKCRN) portfolio. Recruitment of the first participant occurred 04/02/2014.
authors: Faculty of Health Sciences, University of Southampton, Southampton, UK.
authors: Sarah
authors: S
authors: Bailey
authors: Faculty of Health Sciences, University of Southampton, Southampton, UK.
authors: Chris
authors: C
authors: Bailey
authors: School of Psychology, Cardiff University, Cardiff, UK.
authors: Jacky
authors: J
authors: Boivin
authors: Department of Obstetrics and Gynaecology, Academic Unit of Human Development and Health, University of Southampton, Southampton, UK.
authors: Ying
authors: Y
authors: Cheong
authors: Faculty of Medicine, University of Southampton, Southampton, UK.
authors: Isabel
authors: I
authors: Reading
authors: Department of Obstetrics and Gynaecology, Academic Unit of Human Development and Health, University of Southampton, Southampton, UK.
authors: Nick
authors: N
authors: Macklon
mesh_terms: D000026:Abortion, Habitual / Q000523:psychology*; D000223:Adaptation, Psychological / Q000502:physiology*; D000328:Adult; D001007:Anxiety / Q000523:psychology*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D011247:Pregnancy; D011788:Quality of Life / Q000523:psychology*; D012944:Social Support; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology
keywords: GYNAECOLOGY