Clinical Trial: Feasibility Study of a Coping Intervention for Recurrent Miscarriage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage

Brief Summary: Some women experience the pain of miscarriage on numerous occasions. Studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. This study will investigate whether a coping strategy, developed for a similar group of women, would be acceptable and useful to women suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A secondary aim of the study is to develop a deeper understanding of the experiences and feelings of women in the early stages of a new pregnancy, following multiple miscarriages.

Detailed Summary:
Sponsor: University Hospital Southampton NHS Foundation Trust

Current Primary Outcome:

• Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable [ Time Frame: Through Study Completion - Average of 1 year ]
  How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?
• Number of patients recruited into the study using current inclusion/exclusion criteria [ Time Frame: Through Study Completion - Average of 1 year ]
  Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?
• Number of completed questionnaires [ Time Frame: Through Study Completion - Average of 1 year ]
  Are the proposed study questionnaires and data collection methods appropriate?
• Data collected from questionnaires [ Time Frame: Through Study Completion - Average of 1 year ]
  Is there a preliminary indication of an effect of the PRCI?

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Data Collected from questionnaires [ Time Frame: Through Study Completion - Average of 1 year ]
  Qualitative analysis of questionnaires to explore in-depth women's subjective experience of the study intervention and research methods (including study outcome measures).
• Data Collected from questionnaires [ Time Frame: Through Study Completion - Average of 1 year ]
  Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).
• Data Collected from questionnaires [ Time Frame: Through Study Completion - Average of 1 year ]
  Qualitative analysis of questionnaires to strengthen further in-depth understanding of the initial experience of pregnancy following repeated miscarriages.

Original Secondary Outcome: Same as current

Information By: University Hospital Southampton NHS Foundation Trust

Dates:
Date Received: October 14, 2016
Date Started: January 2014
Date Completion: May 2017
Last Updated: December 7, 2016
Last Verified: December 2016