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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Will receive the PRCI in addition to the current recommended care pathway |
|
| Control Group | No Intervention | Will follow the current recommended care pathway |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Reappraisal Coping Intervention | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Anne Hospital | Southampton | SO16 8YD | United Kingdom |
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |