Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-05 @ 8:13 AM
Study NCT ID:
NCT02515604
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2015-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000030', 'term': 'Abortion, Missed'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2015-08-02', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)', 'timeFrame': 'Day 8 from first misoprostol dose', 'description': 'Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Abortion, Missed']}, 'referencesModule': {'references': [{'pmid': '28402415', 'type': 'DERIVED', 'citation': 'Mizrachi Y, Dekalo A, Gluck O, Miremberg H, Dafna L, Feldstein O, Weiner E, Bar J, Sagiv R. Single versus repeat doses of misoprostol for treatment of early pregnancy loss-a randomized clinical trial. Hum Reprod. 2017 Jun 1;32(6):1202-1207. doi: 10.1093/humrep/dex074.'}]}, 'descriptionModule': {'briefSummary': 'A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.\n* Age equal or greater than 18 years\n* Gestational age less than 12 complete weeks.\n\nExclusion Criteria:\n\n* Complete, incomplete, inevitable, or septic abortion.\n* Hemodynamically unstable patients.\n* Misoprostol sensitivity or contraindication.\n* Multifetal pregnancies.'}, 'identificationModule': {'nctId': 'NCT02515604', 'briefTitle': 'Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure - a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '0104-15-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single dose group', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Repeated dose group', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'armGroupLabels': ['Repeated dose group', 'Single dose group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'country': 'Israel', 'facility': 'Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'overallOfficials': [{'name': 'Yossi Mizrachi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wolfson Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yossi Mizrachi', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}