Feasibility study of a coping Intervention for recurrent miscarriage

ISRCTN ISRCTN43571276
DOI https://doi.org/10.1186/ISRCTN43571276
Secondary identifying numbers 15894
Submission date
18/02/2014
Registration date
18/02/2014
Last edited
19/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Sarah Bailey
Scientific

Wessex Clinical Genetics Service
Coxford Road
Southampton
SO16 5YA
United Kingdom

Email SarahL.Bailey@soton.ac.uk

Study information

Study designRandomised; Interventional and Observational; Design type: Qualitative
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA feasibility and acceptability study and a qualitative process evaluation of a coping intervention for women with recurrent miscarriage
Study objectivesSome 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.

Women who have experienced three or more first trimester miscarriages will be eligible and invited to take part in the study. The study will take place within two recurrent miscarriage referral hospitals in the South of England.
Ethics approval(s)13/SC/0506
Health condition(s) or problem(s) studiedTopic: Reproductive Health and Childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth
InterventionPRCI, The Positive Reappraisal Coping Intervention (PRCI) consists of a small card that contains 10 positive reappraisal statements and aims to encourage women who have experienced recurrent miscarriage to redefine the waiting period of a subsequent pregnancy more positively.
Intervention typeBehavioural
Primary outcome measureThis study is a mixed method feasibility study; it is not powered to demonstrate clinical outcomes
Secondary outcome measuresNot provided at time of registration
Overall study start date17/01/2014
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned Sample Size: 50; UK Sample Size: 50
Key inclusion criteria1. Women who have experienced three or more first trimester miscarriages.
2. Women aged 18 years and over.
3. Women who are willing and able to give written consent.; Target Gender: Female ; Lower Age Limit 18 years
Key exclusion criteriaWomen 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 the PRCI) are not currently available in translation.
Date of first enrolment17/01/2014
Date of final enrolment30/04/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University Hospital Southampton NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Government

NIHR Clinical Doctoral Research Fellowship; Grant Codes: CDRF-2012-03-004

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination plan2017 results published in thesis: https://eprints.soton.ac.uk/422273/
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 15/04/2015 Yes No
Results article qualitative results 01/06/2019 19/05/2020 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

19/05/2020: Publication reference added.
29/10/2018: Thesis added to publication and dissemination plan.