Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding
April 26, 2016 updated by: Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey, 34668
- Recruiting
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
-
-
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
35 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Abnormal uterine bleeding
Exclusion Criteria:
- Involuntary, under 35 years old,
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
|
|
ACTIVE_COMPARATOR: Endometrial curettage
Only routine endometrial curettage performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical cytological results according to Bethesda 2003
Time Frame: 1 month
|
for endometrial washing sample
|
1 month
|
|
Endometrial hyperplasiz classification according to World Health Organization 2013
Time Frame: 1 month
|
for endometrial curretage sampling
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moschos E, Ashfaq R, McIntire DD, Liriano B, Twickler DM. Saline-infusion sonography endometrial sampling compared with endometrial biopsy in diagnosing endometrial pathology. Obstet Gynecol. 2009 Apr;113(4):881-887. doi: 10.1097/AOG.0b013e31819b3fc7.
- Rotenberg O, Renz M, Reimers L, Doulaveris G, Gebb J, Goldberg GL, Dar P. Simultaneous endometrial aspiration and sonohysterography for the evaluation of endometrial pathology in women aged 50 years and older. Obstet Gynecol. 2015 Feb;125(2):414-423. doi: 10.1097/AOG.0000000000000631.
- Bese T, Demirkiran F, Guralp O, Sanioglu C, Arvas M. Transtubal transport of carcinoma cells into the peritoneal cavity after saline infusion via transcervical route in patients with endometrial carcinoma. Int J Gynecol Cancer. 2009 May;19(4):682-5. doi: 10.1111/IGC.0b013e3181a48c7f.
Helpful Links
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
January 1, 2016
Primary Completion (ANTICIPATED)
May 1, 2016
Study Completion (ANTICIPATED)
June 1, 2016
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
February 20, 2016
First Posted (ESTIMATE)
February 25, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
April 27, 2016
Last Update Submitted That Met QC Criteria
April 26, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 168
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.