Feasibility Study of a Coping Intervention for Recurrent Miscarriage

Study Overview
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Brief Summary
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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.

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

Conditions
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Miscarriage

Intervention / Treatment
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* Other: Positive Reappraisal Coping Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with three or more miscarriages Women aged >18 years Willing and able to give written consent Exclusion Criteria: Women will be excluded from this study if they do not speak English well enough to understand and complete study materials. This criterion is in place because the study materials (including PRCI) are not currently available in translation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Will receive the PRCI in addition to the current recommended care pathway | Other: Positive Reappraisal Coping Intervention<br> <br> |
| No Intervention: Control Group<br>Will follow the current recommended care pathway | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Miscarriage