The Role of TVSG and HS in Determining Endometrial Pathologies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-01

Study Completion Date

2011-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Abnormal Uterine Bleeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Transvaginal ultrasound

Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples.

Group Type OTHER

Transvaginal ultrasound

Intervention Type DEVICE

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.

Group Type OTHER

Hysteroscopy

Intervention Type DEVICE

Interventions

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Transvaginal ultrasound

Intervention Type DEVICE

Hysteroscopy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes