Feasibility Study of a Coping Intervention for Recurrent Miscarriage

Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989220
• Other study ID #: RHM O&G0207
• Status: Completed
• Phase: N/A
• Start date: January 17, 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: September 2018
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage

Intervention

Other:
• Positive Reappraisal Coping Intervention

Locations

Country	Name	City	State
United Kingdom	Princess Anne Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of completed questionnaires	Are the proposed study questionnaires and data collection methods appropriate?	Through Study Completion - Average of 1 year
Primary	Data collected from questionnaires	Is there a preliminary indication of an effect of the PRCI?	Through Study Completion - Average of 1 year
Secondary	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
Secondary	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
Secondary	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