Condition category
Pregnancy and Childbirth
Date applied
18/02/2014
Date assigned
18/02/2014
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sarah Bailey

ORCID ID

Contact details

Wessex Clinical Genetics Service
Coxford Road
Southampton
SO16 5YA
United Kingdom
-
SarahL.Bailey@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15894

Study information

Scientific title

A feasibility and acceptability study and a qualitative process evaluation of a coping intervention for women with recurrent miscarriage

Acronym

Study hypothesis

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.

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

13/SC/0506

Study design

Randomised; Interventional and Observational; Design type: Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Reproductive Health and Childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth

Intervention

PRCI, 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 type

Behavioural

Phase

Drug names

Primary outcome measures

This study is a mixed method feasibility study; it is not powered to demonstrate clinical outcomes

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/01/2014

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant 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 the PRCI) are not currently available in translation.

Recruitment start date

17/01/2014

Recruitment end date

30/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Portsmouth Hospitals NHS Trust
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25877278

Publication citations

Additional files

Editorial Notes