The Role of TVSG and HS in Determining Endometrial Pathologies

February 22, 2018 updated by: Nazlı YENIGUL, Sisli Hamidiye Etfal Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transvaginal ultrasound
Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples.
Device: Transvaginal ultrasound
Other: Hysteroscopy
Hysteroscopy was also performed under general anesthesia.Hysteroscopy was performed by a single operator (NNY).The operator and two supervising endoscopists were blinded to the ultrasound results.After the hysteroscopy, endometrial sampling was also done. The diagnoses were compared with the received endometrial samples.
Device: Hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy
Time Frame: up to 12 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

  • Study Director: Nefise Nazlı YENIGUL, MD, Sisli Etfal Research and Training hospital, Obstetrics and gynecology department Istanbul, Marmara Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2011

Study Completion (Actual)

December 31, 2011

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 349

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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