Evaluating the CORE-10 as an assessment measure of psychological distress in women 3 months after miscarriage

Plain English Summary

Background and study aims
In the UK it is estimated that mental illness affects 1 in 5 women during pregnancy and after birth with a cost to society of £8.1 billion for every annual cohort of births. Miscarriage is defined as the loss of a pregnancy before viability, which in the UK includes pregnancy losses from conception until 23 weeks and 6 days gestation. Miscarriage is common with an estimated 23 million miscarriages occurring every year worldwide, translating to 44 pregnancy losses each minute.
Miscarriage can be a deeply distressing experience. The psychological impact of miscarriage can go unrecognised by healthcare professionals, family and friends. However, anxiety, depression and PTSD are all strongly associated with miscarriage. In 2020, a study of 537 women following miscarriage found that 9 months after a pregnancy loss, 6% of women met the criteria for moderate or severe depression, 17% for moderate or severe anxiety and 18% for post-traumatic stress. Identifying women at risk of psychological distress following miscarriage and the development of optimal treatment strategies have been recognised as research priorities. This study aims to evaluate the diagnosis accuracy of the CORE-10 online questionnaire in identifying women who meet the DSM-V diagnostic criteria for psychopathology.

Who can participate?
Women aged 18 years and over who have experienced an involuntary pregnancy loss (miscarriage <24 weeks, stillbirth, neonatal death, ectopic pregnancy, gestational trophoblastic disease [molar pregnancy], or recurrent miscarriage)

What does the study involve?
Work package 1: This work package will involve confirmation of any subsequent pregnancy since the miscarriage diagnosis was made, completion of the CORE-10 questionnaire and a diagnostic interview completed online via the online CORE-10 database.
Work package 2: About 40 women from WP1 will complete surveys and interviews to evaluate their perspective of the CORE-10 online questionnaire.

What are the possible benefits and risks of participating?
At the moment there is not enough evidence to say whether the CORE-10 is the best way of identifying women who have prolonged psychological distress following miscarriage.
It is not known whether participants will benefit personally from taking part in this study, but the knowledge gained will inform future practice and potentially lead to improved detection of mental health problems for women after miscarriage in the future.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
November 2023 to September 2025

Who is funding the study?
Tommy’s (UK)

Who is the main contact?
core-10@contacts.bham.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

University of Birmingham
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Phone	N/A
Email	researchgovernance@contacts.bham.ac.uk
Website	http://www.birmingham.ac.uk/index.aspx
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Charity

Results and Publications

Editorial Notes

21/01/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2025 to 31/05/2025.
2. The overall end date was changed from 31/05/2025 to 30/09/2025.
3. The intention to publish date was changed from 01/06/2025 to 31/12/2025.
4. The plain English summary was updated to reflect these changes.
10/09/2024: Internal review.
27/08/2024: Internal review.
16/07/2024: Study's existence confirmed by the West Midlands - South Birmingham Research Ethics Committee.