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The Role of TVSG and HS in Determining Endometrial Pathologies

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03441087
Collaborator
(none)
216
Enrollment
2
Arms
12
Actual Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Transvaginal ultrasound
  • Device: Hysteroscopy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Ultrasound and Hysteroscopy's Place on the Diagnosis of Abnormal Uterin Bleeding
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 31, 2011
Actual Study Completion Date :
Dec 31, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy [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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 51 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nazlı YENIGUL, Principal Investigator MD, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT03441087
Other Study ID Numbers:
  • 349
First Posted:
Feb 22, 2018
Last Update Posted:
Feb 26, 2018
Last Verified:
Feb 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nazlı YENIGUL, Principal Investigator MD, Sisli Hamidiye Etfal Training and Research Hospital
transvaginal ultrasonography
hysteroscopy
abnormal uterine bleeding
Additional relevant MeSH terms:
Uterine Hemorrhage
Hemorrhage

Study Results

No Results Posted as of Feb 26, 2018