Feasibility Study of a Coping Intervention for Recurrent Miscarriage

NCT ID: NCT02989220

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-17

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Positive Reappraisal Coping Intervention

Intervention Type OTHER

Control Group

Will follow the current recommended care pathway

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Positive Reappraisal Coping Intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Princess Anne Hospital

Southampton, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RHM O&G0207

Identifier Type: -

Identifier Source: org_study_id

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