Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-23 @ 10:00 AM
Study NCT ID:
NCT02679092
Status:
WITHDRAWN
Last Update Posted:
2019-09-19
First Post:
2016-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004108', 'term': 'Dilatation, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D015735', 'term': 'Mifepristone'}], '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'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding changes.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2016-02-09', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Time', 'timeFrame': 'Intraoperative', 'description': 'Measured as time from speculum insertion to removal.'}], 'secondaryOutcomes': [{'measure': 'Cervical Dilation', 'timeFrame': 'Baseline', 'description': 'Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure'}, {'measure': 'Total Procedure Time', 'timeFrame': 'Measured at clinic visit and on OR day, over 2 day period', 'description': 'All time required by patient (time in clinic for cervical preparation procedures)'}, {'measure': 'Difficulty of Procedure, as reported by clinician', 'timeFrame': 'Measured within 5 minutes after procedure', 'description': 'Using Visual Analogue Scale (VAS)'}, {'measure': 'Complications/Adverse Events', 'timeFrame': 'Intraoperatively', 'description': 'Estimated blood loss, uterine injury, infection, retained products of conception'}, {'measure': 'Pain Perceived by Patient', 'timeFrame': 'Intraoperatively "Measured during dilator placement"', 'description': 'Using Visual Analogue Scale (VAS)'}, {'measure': 'Overall Patient Experience', 'timeFrame': 'Measured post-operatively (30 minutes prior to discharge)', 'description': 'Using Visual Analogue Scale (VAS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Induced Abortion', 'Mifepristone', 'Dilation and Evacuation', 'Cervical Preparation', 'Osmotic Dilators', 'Misoprostol'], 'conditions': ['Legally Induced Abortion Without Mention of Complication']}, 'descriptionModule': {'briefSummary': 'Dilation and evacuation (D\\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D\\&E.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 Years Old\n* Viable, Singleton pregnancy\n* Voluntarily seeking abortion between 14-19 weeks gestation\n* Able to give informed consent and comply with study protocol\n* Fluent in English or Spanish\n\nExclusion Criteria:\n\n* Allergy to study drugs'}, 'identificationModule': {'nctId': 'NCT02679092', 'briefTitle': 'Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks', 'orgStudyIdInfo': {'id': 'IRB-36302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dilapan (14wks 0days-15wks, 6days)', 'description': "The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.", 'interventionNames': ['Device: Hygroscopic cervical dilators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dilapan (16wks 0days-18wks, 6days)', 'description': 'The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.', 'interventionNames': ['Drug: Misoprostol', 'Device: Hygroscopic cervical dilators']}, {'type': 'EXPERIMENTAL', 'label': 'Mifepristone (14wks 0days-15wks, 6days)', 'description': 'The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.', 'interventionNames': ['Drug: Misoprostol', 'Drug: Mifepristone']}, {'type': 'EXPERIMENTAL', 'label': 'Mifepristone (16wks 0days-18wks, 6days)', 'description': 'The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.', 'interventionNames': ['Drug: Misoprostol', 'Drug: Mifepristone']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': '400 mcg buccal 60-90 minutes prior to procedure', 'armGroupLabels': ['Dilapan (16wks 0days-18wks, 6days)', 'Mifepristone (14wks 0days-15wks, 6days)', 'Mifepristone (16wks 0days-18wks, 6days)']}, {'name': 'Mifepristone', 'type': 'DRUG', 'otherNames': ['Danco', 'Mifeprex'], 'description': '200 mg PO on the day prior to D\\&E', 'armGroupLabels': ['Mifepristone (14wks 0days-15wks, 6days)', 'Mifepristone (16wks 0days-18wks, 6days)']}, {'name': 'Hygroscopic cervical dilators', 'type': 'DEVICE', 'otherNames': ['Dilapan-S'], 'description': 'osmotic cervical dilators inserted through the internal os', 'armGroupLabels': ['Dilapan (14wks 0days-15wks, 6days)', 'Dilapan (16wks 0days-18wks, 6days)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95126', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Planned Parenthood Mar Monte', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'overallOfficials': [{'name': 'Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}