Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-25 @ 6:00 AM
Study NCT ID:
NCT03044093
Status:
UNKNOWN
Last Update Posted:
2017-02-06
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Hospital Stay Duration', 'timeFrame': 'Up to 24 months', 'description': 'number of days of hospital stay'}]}, 'conditionsModule': {'conditions': ['Second Trimester Abortion']}, 'descriptionModule': {'briefSummary': 'Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* no allergy known to these drugs\n* second trimester abortion\n\nExclusion Criteria:\n\n* hematology diseases\n* clotting factor deficiency'}, 'identificationModule': {'nctId': 'NCT03044093', 'briefTitle': 'Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion', 'orgStudyIdInfo': {'id': '0299-16-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MISOPROSTOL alone', 'description': 'the common practice currently in our medical center for second trimester medical abortion/ Placebo', 'interventionNames': ['Drug: Placebo', 'Drug: Misoprostol']}, {'type': 'EXPERIMENTAL', 'label': 'Mifepristone and Misoprostol', 'description': 'in addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol.\n\nMifepristone', 'interventionNames': ['Drug: Mifepristone', 'Drug: Misoprostol']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'The group that will get in addition to Misoprostol also Mifepristone', 'armGroupLabels': ['Mifepristone and Misoprostol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The group that will only get Misoprostol', 'armGroupLabels': ['MISOPROSTOL alone']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': 'Both groups will get think drug', 'armGroupLabels': ['MISOPROSTOL alone', 'Mifepristone and Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'MEIR NIZRI, MD', 'role': 'CONTACT'}], 'facility': 'Rambam Medical Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'MEIR NIZRI, MD', 'role': 'CONTACT', 'phone': '972-50-2061521'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}