Feasibility study of a coping Intervention for recurrent miscarriage
| ISRCTN | ISRCTN43571276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43571276 |
| Protocol serial number | 15894 |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funder | NIHR Clinical Doctoral Research Fellowship; Grant Codes: CDRF-2012-03-004 |
- 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
Scientific
Wessex Clinical Genetics Service
Coxford Road
Southampton
SO16 5YA
United Kingdom
| SarahL.Bailey@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional and Observational; Design type: Qualitative |
| Secondary study design | Randomised controlled trial |
| Scientific title | A feasibility and acceptability study and a qualitative process evaluation of a coping intervention for women with recurrent miscarriage |
| Study objectives | 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(s) | 13/SC/0506 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
This study is a mixed method feasibility study; it is not powered to demonstrate clinical outcomes |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 17/01/2014 |
| Date of final enrolment | 30/04/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
University Hospital Southampton NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth
PO6 3LY
United Kingdom
PO6 3LY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | qualitative results | 01/06/2019 | 19/05/2020 | Yes | No |
| Protocol article | protocol | 15/04/2015 | 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.
