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Completed

NCT Number: NCT02989220

Feasibility Study of a Coping Intervention for 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.

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Key information

Conditions

Miscarriage Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Princess Anne Hospital

Southampton, SO16 8YD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Reappraisal Coping Intervention

Other

Primary outcomes

  1. Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable

    Time frame: Through Study Completion - Average of 1 year

    How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?

  2. Number of patients recruited into the study using current inclusion/exclusion criteria

    Time frame: 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?

  3. Number of completed questionnaires

    Time frame: Through Study Completion - Average of 1 year

    Are the proposed study questionnaires and data collection methods appropriate?

  4. Data collected from questionnaires

    Time frame: Through Study Completion - Average of 1 year

    Is there a preliminary indication of an effect of the PRCI?

Secondary outcomes

  1. Data Collected from questionnaires

    Time frame: Through Study Completion - Average of 1 year

    Qualitative analysis of questionnaires to explore in-depth women's subjective experience of the study intervention and research methods (including study outcome measures).

  2. Data Collected from questionnaires

    Time frame: Through Study Completion - Average of 1 year

    Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).

  3. Data Collected from questionnaires

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 12, 2016
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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