Tenaculum in Endometrial Sampling Procedure (Tenaculum)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01506778|
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : January 10, 2012
|Condition or disease||Intervention/treatment|
|Endometrium Biopsy||Device: Tenaculum|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.|
|Study Start Date :||May 2011|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Active Comparator: Group 1(With Tenaculum)
This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure
Single tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum.
No Intervention: Group 2 (Without Tenaculum)
This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure.
- Visual Analog Scala for patient's pain perception [ Time Frame: 5 second ]VAS performed four times each patient.
- Likert scala for procedure performance [ Time Frame: 5 second ]Likert scaled one times by the physician.
- Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis. [ Time Frame: 5-10 day ]
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): NCT01506778
|Cukurova University Faculty of Medicine|
|Adana, Turkey, 01330|
|Principal Investigator:||Ahmet Baris Guzel, Assist Prof Dr.||Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology|
|Principal Investigator:||Aybala Kubat, MD||Şahinbey Goverment Hospital|
|Principal Investigator:||Ghanim Khatib, MD||Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology|
|Principal Investigator:||Fatma Tuncay Ozgunen, Prof Dr.||Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology|
|Principal Investigator:||Ibrahim Ferhat Urunsak, Assist Prof Dr.||Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology|
|Study Director:||Umran Kucukgoz Gulec, Assist Prof Dr.||Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology|