Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-25 @ 1:48 AM
Study NCT ID:
NCT01933360
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2013-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol for Cervical Priming Prior to Vacuum Aspiration
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2013-08-25', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Force needed for cervical dilatation', 'timeFrame': 'Measured at surgery', 'description': 'Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer. Force and time needed for the dilatation is recorded by the tonometer'}], 'secondaryOutcomes': [{'measure': 'Cervical diameter', 'timeFrame': 'Measured at surgery', 'description': 'Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer.The largest dilator that can pass through the inner cervical os without any resistance corresponds to the presurgical cervical diameter'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Up to surgery', 'description': 'Any side effects or symptoms such as nausea, vomiting, uterine cramps, expulsion, bleeding, rash, chills, blood pressure etc are recorded continuously from misoprostol administration until to surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Misoprostol', 'First trimester pregnancy', 'Surgical abortion', 'Cervical priming'], 'conditions': ['First Trimester Pregnancy', 'Surgical Termination of Pregnancy']}, 'referencesModule': {'references': [{'pmid': '25840429', 'type': 'DERIVED', 'citation': 'Saav I, Kopp Kallner H, Fiala C, Gemzell-Danielsson K. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT. Hum Reprod. 2015 Jun;30(6):1314-22. doi: 10.1093/humrep/dev071. Epub 2015 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women opting for first trimester surgical abortion\n* nulliparous\n* able and willing to provide informed consent\n\nExclusion Criteria:\n\n* unwilling to participate,\n* unable to communicate in Swedish and English and\n* minors (i.e. women \\< 18 years of age),\n* contraindications to misoprostol\n* women with pathological pregnancies'}, 'identificationModule': {'nctId': 'NCT01933360', 'briefTitle': 'Misoprostol for Cervical Priming Prior to Vacuum Aspiration', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Sublingual Versus Vaginal Misoprostol for Cervical Dilatation 1 or 3 Hours Prior to Surgical Abortion', 'orgStudyIdInfo': {'id': 'W500M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol sublingual,1h', 'description': 'Administration of misoprostol sublingually 1h prior to surgery', 'interventionNames': ['Drug: Misoprostol sublingual, 1h', 'Drug: Placebo vaginal, 1h']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol sublingual. 3h', 'description': 'Administration of misoprostol sublingually 3h prior to surgery', 'interventionNames': ['Drug: Misoprostol sublingual, 3h', 'Drug: Placebo vaginal, 3h']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol vaginal,1h', 'description': 'Administration of misoprostol vaginally 1h prior to surgery', 'interventionNames': ['Drug: Placebo sublingual,1h', 'Drug: Misoprostol vaginal, 1h']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol vaginal,3h', 'description': 'Administration of misoprostol vaginally 3h prior to surgery', 'interventionNames': ['Drug: Misoprostol vaginal, 3h', 'Drug: Placebo sublingual, 3h']}], 'interventions': [{'name': 'Misoprostol sublingual, 1h', 'type': 'DRUG', 'otherNames': ['Misoprostol (Cytotec)'], 'description': 'Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol sublingual,1h']}, {'name': 'Placebo sublingual,1h', 'type': 'DRUG', 'description': 'Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol vaginal,1h']}, {'name': 'Misoprostol sublingual, 3h', 'type': 'DRUG', 'description': 'Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol sublingual. 3h']}, {'name': 'Misoprostol vaginal, 1h', 'type': 'DRUG', 'description': 'Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol vaginal,1h']}, {'name': 'Misoprostol vaginal, 3h', 'type': 'DRUG', 'description': 'Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol vaginal,3h']}, {'name': 'Placebo sublingual, 3h', 'type': 'DRUG', 'description': 'Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol vaginal,3h']}, {'name': 'Placebo vaginal, 1h', 'type': 'DRUG', 'description': 'Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol sublingual,1h']}, {'name': 'Placebo vaginal, 3h', 'type': 'DRUG', 'description': 'Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy', 'armGroupLabels': ['Misoprostol sublingual. 3h']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Kristina Gemzell Danielsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kristina Gemzell Danielsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}