Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy
NCT ID: NCT02328495
Last Updated: 2016-07-27
Study Results
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Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2015-01-31
2016-03-31
Brief Summary
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Detailed Description
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The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Misoprostol
Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy
Misoprostol
Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic.
Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).
bladder Filling
Uterine straightening by bladder filling before office hysteroscopy
Bladder Filling
Patients in bladder filling group will be instructed to drink one liter of water and to avoid urination during the one and half hour period before office hysteroscopy procedure..A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach . All the procedures will be diagnostic.
Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used.
Interventions
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Misoprostol
Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic.
Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).
Bladder Filling
Patients in bladder filling group will be instructed to drink one liter of water and to avoid urination during the one and half hour period before office hysteroscopy procedure..A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach . All the procedures will be diagnostic.
Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
75 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Usama M Fouda
M.D, PhD
Principal Investigators
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Usama M Fouda, M.D,PhD
Role: STUDY_CHAIR
Cairo University
Locations
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Obstetrics and Gynecology Department,Cairo university
Cairo, Cairo Governorate, Egypt
Countries
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References
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Celik C, Tasdemir N, Abali R, Bastu E, Akbaba E, Yucel SH, Gul A. The effect of uterine straightening by bladder distention before outpatient hysteroscopy: a randomised clinical trial. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:89-92. doi: 10.1016/j.ejogrb.2014.06.029. Epub 2014 Jul 7.
Fouda UM, Elshaer HS, Elsetohy KA, Youssef MA. Misoprostol versus uterine straightening by bladder distension for pain relief in postmenopausal patients undergoing diagnostic office hysteroscopy: a randomised controlled non-inferiority trial. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:326-30. doi: 10.1016/j.ejogrb.2016.06.024. Epub 2016 Jul 1.
Other Identifiers
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Misoprostol /bladder/hystero
Identifier Type: -
Identifier Source: org_study_id
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