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Feasibility Study of a Coping Intervention for Recurrent Miscarriage

U

University Hospital Southampton NHS Foundation Trust

Status

Completed

Conditions

Miscarriage

Treatments

Other: Positive Reappraisal Coping Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02989220
RHM O&G0207

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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