Endometrial Lesions Predictions

NCT05588076UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Beijing Friendship Hospital

Enrollment

900

Start Date

2021-10-01

Completion Date

2022-10-01

Study Type

OBSERVATIONAL

Official Title

Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding

Interventions

no intervention

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years – 60 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

pathology of endometrial lesions

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.

Time frame: 1 year

Secondary Outcomes

Ultrasonographic Examination

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

Time frame: 1 year

Locations

Beijing Friendship Hospital, Beijing, China

Endometrial Lesions Predictions