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Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy

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: NCT02328495
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Usama M Fouda, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Misoprostol Other: Bladder Filling Phase 2

Detailed Description:

Several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. A recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy. A Randomized Controlled Trial
Study Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Active Comparator: Misoprostol
Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy
Drug: 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).


Active Comparator: bladder Filling
Uterine straightening by bladder filling before office hysteroscopy
Other: 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.





Primary Outcome Measures :
  1. Intensity of pain [ visual analogue scale ranging from 0 to 10 ] [ Time Frame: Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 10 minutes] and 30 minutes after the procedure ]

Secondary Outcome Measures :
  1. Operative time [ Time Frame: From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes] ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Menopausal patients who have an indication for office hysteroscopy

Exclusion Criteria:

  • Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.

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): NCT02328495


Locations
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Egypt
Obstetrics and Gynecology Department,Cairo university
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Usama M Fouda, M.D,PhD Cairo University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Usama M Fouda, M.D, PhD, Cairo University
ClinicalTrials.gov Identifier: NCT02328495    
Other Study ID Numbers: Misoprostol /bladder/hystero
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Keywords provided by Usama M Fouda, Cairo University:
Misoprostol, Office hysteroscopy ,Pain
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics