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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25877278