Feasibility Study of a Coping Intervention for Recurrent Miscarriage

NCT02989220 | Completed

• 1 other identifier: RHM O&G0207
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Miscarriage

Keywords

Miscarriage

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Data Collected from questionnaires

  Through Study Completion - Average of 1 year

• Data Collected from questionnaires

  Through Study Completion - Average of 1 year

• Data Collected from questionnaires

  Through Study Completion - Average of 1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Positive Reappraisal Coping Intervention

Control Group

NO INTERVENTION

Will follow the current recommended care pathway

Interventions

Positive Reappraisal Coping Intervention OTHER

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with three or more miscarriages
• Women aged \>18 years
• Willing and able to give written consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

Princess Anne Hospital

Southampton, SO16 8YD, United Kingdom

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: December 12, 2016
• Study Start: January 17, 2014
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

GB (1)