Miscarriage
Conditions
Keywords
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.
Interventions
OTHERPositive Reappraisal Coping Intervention
Sponsors
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable | 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 | 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 | Through Study Completion - Average of 1 year | Are the proposed study questionnaires and data collection methods appropriate? |
| Data collected from questionnaires | Through Study Completion - Average of 1 year | Is there a preliminary indication of an effect of the PRCI? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Data Collected from questionnaires | 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). |
Countries
United Kingdom
Outcome results
None listed