Endometrial Lesions Predictions

Active, not recruiting

• Conditions: Endometrial Neoplasms
• Interventions: Other: no intervention

• Registration Number: NCT05588076
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

• 1. non-pregnancy related abnormal uttering bleeding（AUB） in women of 18-60 years old; 2)women who had indications for hysteroscopy and endometrial histology in the study period

Exclusion Criteria

• 1. postmenopausal women, 2) AUB due to other causes such as hormones or medications, coagulation disorders, and vascular malformation of the uterus; 3) final diagnosis outside the scope of this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal endometrial	no intervention	-

Primary Outcome Measures

Name	Time	Method
pathology of endometrial lesions	1 year	Endometrial tissue was curettaged and sent for pathological examination in 10% formalin. A senior pathologist who was not blinded to clinical and ultrasound information examined the samples and determined the final diagnosis. The outcomes of histology are classified as normal endometrium and endometrial lesions, which include 1)endometrial polyps,2)endometrial hyperplasia without atypia, 3)endometrial atypical hyperplasia and 4) endometrial carcinoma.

Secondary Outcome Measures

Name	Time	Method
Ultrasonographic Examination	1 year	VS examinations were performed by an experienced physician with a vaginal probe of 5.5 MHz of a GE VolusonE10 Ultrasound device to look for endometrial thickness and abnormal echoes. Endometrial thickness (ET) was measured at the thickest part with double layers

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, China