Feasibility Study of a Coping Intervention for Recurrent Miscarriage

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

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.

Study Overview

• Status: Completed
• Conditions: Miscarriage
• Intervention / Treatment: Other: Positive Reappraisal Coping Intervention

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom, SO16 8YD
    • Princess Anne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Will receive the PRCI in addition to the current recommended care pathway	Other: Positive Reappraisal Coping Intervention
No Intervention: Control Group; Will follow the current recommended care pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2014
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Miscarriage
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Habitual
• Other Study ID Numbers: RHM O&G0207