The Role of TVSG and HS in Determining Endometrial Pathologies

Abnormal Uterine Bleeding Clinical Trial

Official title:

Ultrasound and Hysteroscopy's Place on the Diagnosis of Abnormal Uterin Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441087
• Other study ID #: 349
• Status: Completed
• Phase: N/A
• First received: February 15, 2018
• Last updated: February 22, 2018
• Start date: January 1, 2011
• Est. completion date: December 31, 2011

Study information

• Verified date: February 2018
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 31, 2011
• Est. primary completion date: December 31, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 51 Years

Eligibility

Inclusion Criteria:

• patients who have no history of hysteroscopy and curettage,

• patients who have no history of ovulatory dysfunction

• women who have active vaginal bleeding.

Exclusion Criteria:

• presence of genital infections/PID

• presence of pregnancy

• presence of vaginal or cervical pathology causing vaginal bleeding

• women who are receiving hormonal treatment (COC/HRT)

• patients formerly diagnosed with endometrial pathology

• patients having coagulopathy

• women who are using intrauterine device.

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Hemorrhage
• Uterine Hemorrhage

Intervention

Device:
• Transvaginal ultrasound

• Hysteroscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy	The main outcome variable of the study was accuracy of diagnostic performance of transvaginal ultrasonography and hysteroscopy in premenopausal and menopausal women with abnormal uterin bleeding .	up to 12 month