Feasibility Study of a Coping Intervention for Recurrent Miscarriage

Not Applicable

Completed

• Conditions: Miscarriage
• Interventions: Other: Positive Reappraisal Coping Intervention

• Registration Number: NCT02989220
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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 Description

Not available

Study Timeline

• Study Start: 2014-01-17
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-12
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Positive Reappraisal Coping Intervention	Will receive the PRCI in addition to the current recommended care pathway

Primary Outcome Measures

Name	Time	Method
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 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?
Data collected from questionnaires	Through Study Completion - Average of 1 year	Is there a preliminary indication of an effect of the PRCI?
Number of completed questionnaires	Through Study Completion - Average of 1 year	Are the proposed study questionnaires and data collection methods appropriate?

Secondary Outcome Measures

Name	Time	Method
Data Collected from questionnaires	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.

Trial Locations

Locations (1)

Princess Anne Hospital; 🇬🇧 Southampton, United Kingdom