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Feasibility Study of a Coping Intervention for Recurrent Miscarriage

Primary Purpose

Miscarriage

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Positive Reappraisal Coping Intervention
Sponsored by
University Hospital Southampton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Miscarriage focused on measuring Miscarriage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Princess Anne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control Group

Arm Description

Will receive the PRCI in addition to the current recommended care pathway

Will follow the current recommended care pathway

Outcomes

Primary Outcome Measures

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?
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?
Number of completed questionnaires
Are the proposed study questionnaires and data collection methods appropriate?
Data collected from questionnaires
Is there a preliminary indication of an effect of the PRCI?

Secondary Outcome Measures

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).
Data Collected from questionnaires
Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).
Data Collected from questionnaires
Qualitative analysis of questionnaires to strengthen further in-depth understanding of the initial experience of pregnancy following repeated miscarriages.

Full Information

First Posted
October 14, 2016
Last Updated
September 5, 2018
Sponsor
University Hospital Southampton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02989220
Brief Title
Feasibility Study of a Coping Intervention for Recurrent Miscarriage
Official Title
A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 17, 2014 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage
Keywords
Miscarriage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Will receive the PRCI in addition to the current recommended care pathway
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Will follow the current recommended care pathway
Intervention Type
Other
Intervention Name(s)
Positive Reappraisal Coping Intervention
Primary Outcome Measure Information:
Title
Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable
Description
How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?
Time Frame
Through Study Completion - Average of 1 year
Title
Number of patients recruited into the study using current inclusion/exclusion criteria
Description
Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?
Time Frame
Through Study Completion - Average of 1 year
Title
Number of completed questionnaires
Description
Are the proposed study questionnaires and data collection methods appropriate?
Time Frame
Through Study Completion - Average of 1 year
Title
Data collected from questionnaires
Description
Is there a preliminary indication of an effect of the PRCI?
Time Frame
Through Study Completion - Average of 1 year
Secondary Outcome Measure Information:
Title
Data Collected from questionnaires
Description
Qualitative analysis of questionnaires to explore in-depth women's subjective experience of the study intervention and research methods (including study outcome measures).
Time Frame
Through Study Completion - Average of 1 year
Title
Data Collected from questionnaires
Description
Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).
Time Frame
Through Study Completion - Average of 1 year
Title
Data Collected from questionnaires
Description
Qualitative analysis of questionnaires to strengthen further in-depth understanding of the initial experience of pregnancy following repeated miscarriages.
Time Frame
Through Study Completion - Average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Princess Anne Hospital
City
Southampton
ZIP/Postal Code
SO16 8YD
Country
United Kingdom

12. IPD Sharing Statement

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Feasibility Study of a Coping Intervention for Recurrent Miscarriage

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