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

Not Applicable

• Conditions: Miscarriage; Pregnancy and Childbirth

• Registration Number: ISRCTN17424858
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-06
• Last Update Posted: 9 September 2024
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 595

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.