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Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding

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ClinicalTrials.gov Identifier: NCT02691715
Recruitment Status : Unknown
Verified April 2016 by Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
Recruitment status was:  Recruiting
First Posted : February 25, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary:
Investigator will examined the diagnostic effect of the endometrial washing by saline. Because this technique more less painful and easier compared to endometrial curettage. Participants will separate into two groups. In study groups before endometrial curettage 5 cc saline infused to the endometrial cavity then aspirate and put into thin prep to examined. After this procedure routine endometrial curettage will be done. In control group only endometrial curettage will be done. Pathologic results of thin prep and curettage will compared.

Condition or disease Intervention/treatment Phase
Endometrial Disease Procedure: Endometrial saline plus curettage Procedure: Endometrial curettage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2016
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Endometrial saline plus curettage
5 cc saline infused to the endometrial cavity and aspirated. Then routine endometrial curettage performed for same participant.
Procedure: Endometrial saline plus curettage
Active Comparator: Endometrial curettage
Only routine endometrial curettage performed
Procedure: Endometrial curettage



Primary Outcome Measures :
  1. Cervical cytological results according to Bethesda 2003 [ Time Frame: 1 month ]
    for endometrial washing sample

  2. Endometrial hyperplasiz classification according to World Health Organization 2013 [ Time Frame: 1 month ]
    for endometrial curretage sampling



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Abnormal uterine bleeding

Exclusion Criteria:

  • Involuntary, under 35 years old,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691715


Contacts
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Contact: Mehmet Baki Şentürk, MD +90 541 773 71 76 dr.baki77@gmail.com
Contact: Çetin Kılıççı, MD +90 505 644 94 85 cetinkilicci@hotmail.com

Locations
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Turkey
Zeynep Kamil Maternity and Pediatric Research and Training Hospital Recruiting
İstanbul, Turkey, 34668
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital