NCT06293066

Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study.

Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 330 (actual)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To assess whether there is a higher incidence of uninformative ultrasound in black vs white women

Detailed description

Retrospective cohort study Study Subjects: Women 45 years or over seen in the 'two-week wait' rapid access Gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022. Only people with documented ethnicity will be included. Study Procedures: Cases will be identified by searching our two-week referral and ultrasound records . Clinical data collected includes age, BMI, previous abdominal uterine surgery (Caesarean section or open myomectomy) and parity. Symptoms will be categorised into postmenopausal bleeding with no hormone use, unscheduled bleeding on hormone replacement therapy (HRT) or abnormal perimenopausal bleeding (in women over 45 years of age). Ultrasound data recorded will be the presence or absence of fibroids, whether transabdominal ultrasound was needed in addition to transvaginal or transrectal ultrasound, whether the endometrium could be seen clearly (i.e whether the ultrasound examination was informative) and the endometrial thickness in those where it was. Clinical outcomes recorded will be the need for endometrial sampling, mode of sampling and histology results. The local cancer registry will be checked for the year following the study to check for any subsequent cancers in women discharged without endometrial sampling.

Conditions

• Postmenopausal Bleeding
• Endometrial Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound	Usefulness of transvaginal ultrasound

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-07-01
• Completion: 2024-07-15
• First posted: 2024-03-05
• Last updated: 2024-06-11

Locations

1 site across 1 country: United Kingdom