Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT02474433
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2015-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Same-day Cervical Preparation With Misoprostol Before Hysteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2015-06-14', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative cervical width in centimeters', 'timeFrame': 'intraoperative', 'description': 'Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.'}], 'secondaryOutcomes': [{'measure': 'Time required to achieve cervical dilatation', 'timeFrame': 'intraoperative', 'description': 'The time in minutes required for dilatation up to a number 10 Hegar'}, {'measure': 'Ease of cervical dilatation', 'timeFrame': 'intraoperative', 'description': 'The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy)'}, {'measure': 'Patient preference', 'timeFrame': 'baseline', 'description': 'Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)'}, {'measure': 'Adverse effects of medication', 'timeFrame': 'baseline', 'description': 'Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)'}, {'measure': 'Surgical complications', 'timeFrame': 'intraoperative', 'description': 'Complications arising during surgery (perforation, cervical laceration, excess bleeding)'}]}, 'conditionsModule': {'conditions': ['Cervical Preparation Prior to Hysteroscopy']}, 'referencesModule': {'references': [{'pmid': '28069480', 'type': 'DERIVED', 'citation': 'Ganer Herman H, Kerner R, Gluck O, Feit H, Keidar R, Bar J, Sagiv R. Different Routes of Misoprostol for Same-Day Cervical Priming Prior to Operative Hysteroscopy: A Randomized Blinded Trial. J Minim Invasive Gynecol. 2017 Mar-Apr;24(3):455-460. doi: 10.1016/j.jmig.2016.12.024. Epub 2017 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center\n* Written consent supplied\n\nExclusion Criteria:\n\n* Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)\n* Prostaglandin allergy\n* Pregnancy\n* Genital infection\n* Space-occupying lesion in the endocervical canal\n* Prior cervical surgery'}, 'identificationModule': {'nctId': 'NCT02474433', 'briefTitle': 'Same-day Cervical Preparation With Misoprostol Before Hysteroscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Same-day Cervical Preparation With Misoprostol Before Hysteroscopy: a Randomized Trial of Different Routes of Administration', 'orgStudyIdInfo': {'id': '0083-15-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PO Misoprostol', 'description': 'Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy', 'interventionNames': ['Drug: Misoprostol (Cytotec)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PV Misoprostol', 'description': 'Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy', 'interventionNames': ['Drug: Misoprostol (Cytotec)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Buccal Misoprostol', 'description': 'Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy', 'interventionNames': ['Drug: Misoprostol (Cytotec)']}], 'interventions': [{'name': 'Misoprostol (Cytotec)', 'type': 'DRUG', 'armGroupLabels': ['Buccal Misoprostol', 'PO Misoprostol', 'PV Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hadas Ganer Herman, MD', 'role': 'CONTACT', 'email': 'hadassganer@yahoo.com', 'phone': '97235239174'}], 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'centralContacts': [{'name': 'Hadas Ganer Herman, MD', 'role': 'CONTACT', 'email': 'hadassganer@yahoo.com', 'phone': '972526206696'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hadas Ganer Herman', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}