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Completed

NCT Number: NCT03441087

The Role of TVSG and HS in Determining Endometrial Pathologies

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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Key information

Conditions

Abnormal Uterine Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

21 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transvaginal ultrasound

Device

Hysteroscopy

Device

Primary outcomes

  1. 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 .

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 22, 2018
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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