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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17424858
Enrollment
595
Registered
2024-08-06
Start date
2024-08-07
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscarriage Pregnancy and Childbirth

Interventions

The Clinical Outcomes in Routine Evaluation (CORE-10) was suggested as a possible single tool to screen for psychological distress. There was an agreement amongst professionals regarding the availabil

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Female 2. Primiparous or multiparous 3. Ability to provide written informed consent to take part in the study 4. Age =18 years old 5. Diagnosis of miscarriage =16+6 weeks (singleton or multiple pregnancies) acquired from hospital records 6. Recurrent or sporadic miscarriage

Exclusion criteria

Exclusion criteria: 1. Miscarriage =17 weeks 2. Other types of early pregnancy loss (e.g. gestational trophoblastic disease or ectopic pregnancy) acquired from hospital records 3. Termination of pregnancy 4. Prior enrolment in this study

Design outcomes

Primary

MeasureTime frame
Psychological distress is measured using the Clinical Outcomes in Routine Evaluation (CORE-10) online questionnaire, and completed by women 3 months following a miscarriage (work package 1). The CORE-10 questionnaire will be compared with the results of the clinical diagnostic interview (completed within 28 days from the date of the CORE-10 questionnaire).

Secondary

MeasureTime frame
The acceptability of the CORE-10 online questionnaire will be measured by survey, clinical interview and completion of a Likert Scale (work package 2). Forty participants will be randomly selected after the completion of the diagnostic clinical interview.

Countries

England, Scotland, United Kingdom

Contacts

Public ContactLee Priest
l.priest.1@bham.ac.uk

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026