Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 27, 2016
April 1, 2016
4 months
January 28, 2016
April 26, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Cervical cytological results according to Bethesda 2003
for endometrial washing sample
1 month
Endometrial hyperplasiz classification according to World Health Organization 2013
for endometrial curretage sampling
1 month
Study Arms (2)
Endometrial saline plus curettage
EXPERIMENTAL5 cc saline infused to the endometrial cavity and aspirated. Then routine endometrial curettage performed for same participant.
Endometrial curettage
ACTIVE COMPARATOROnly routine endometrial curettage performed
Interventions
Eligibility Criteria
You may qualify if:
- Abnormal uterine bleeding
You may not qualify if:
- Involuntary, under 35 years old,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Istanbul, 34668, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 19305334RESULTRotenberg 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.
PMID: 25568988RESULTBese 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.
PMID: 19509571RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pirincipal investigator
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 25, 2016
Study Start
January 1, 2016
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
April 27, 2016
Record last verified: 2016-04