Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
Study NCT ID:
NCT02328495
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2014-12-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2014-12-23', 'studyFirstSubmitQcDate': '2014-12-30', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of pain [ visual analogue scale ranging from 0 to 10 ]', 'timeFrame': 'Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 10 minutes] and 30 minutes after the procedure'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes]'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Misoprostol, Office hysteroscopy ,Pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '25058804', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27481125', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Menopausal patients who have an indication for office hysteroscopy\n\nExclusion Criteria:\n\n* Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.'}, 'identificationModule': {'nctId': 'NCT02328495', 'briefTitle': 'Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Misoprostol /bladder/hystero'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol', 'description': 'Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bladder Filling', 'description': 'Uterine straightening by bladder filling before office hysteroscopy', 'interventionNames': ['Other: Bladder Filling']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'description': '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.\n\nPain 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).', 'armGroupLabels': ['Misoprostol']}, {'name': 'Bladder Filling', 'type': 'OTHER', 'description': '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.\n\nPain 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.', 'armGroupLabels': ['bladder Filling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Obstetrics and Gynecology Department,Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Usama M Fouda, M.D,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, PhD', 'investigatorFullName': 'Usama M Fouda', 'investigatorAffiliation': 'Cairo University'}}}}