Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01662167
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2012-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012847', 'term': 'Single Person'}], 'ancestors': [{'id': 'D017533', 'term': 'Marital Status'}, {'id': 'D005191', 'term': 'Family Characteristics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-09', 'studyFirstSubmitDate': '2012-08-05', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hCG level decrease', 'timeFrame': '4 days after administration'}]}, 'conditionsModule': {'conditions': ['Pregnancy, Ectopic']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unruptured tubal EP\n* gestational mass of less than or equal to 3.5 cm in ultrasonography report\n\nExclusion Criteria:\n\n* hemodynamic instability\n* contraindications related to the use of MTX\n* hepatic\n* renal and active pulmonary diseases\n* peptic ulcer\n* immune deficiency status\n* alcohol abuse\n* blood dyscreasia'}, 'identificationModule': {'nctId': 'NCT01662167', 'briefTitle': 'Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Hormozgan University of Medical Sciences'}, 'officialTitle': 'Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy: a Clinical Trail', 'orgStudyIdInfo': {'id': 'U1111-1133-3069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple dose mtx', 'description': 'mtx', 'interventionNames': ['Drug: Multipe']}, {'type': 'EXPERIMENTAL', 'label': 'Single Dose', 'description': 'In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved', 'interventionNames': ['Drug: Single']}], 'interventions': [{'name': 'Single', 'type': 'DRUG', 'description': 'In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved', 'armGroupLabels': ['Single Dose']}, {'name': 'Multipe', 'type': 'DRUG', 'description': 'In the multiple dose regimen, 1 mg/kg/day intramuscular methotrexate was given on days one, three, five and seven and 0.1 mg/kg/day intramuscular Citrovoram factor was administered on days two, four, six and eight until serum hCG level decreased 15% in 48 hours or four doses of methotrexate was given weekly until serum hCG level of 15 mlU/ml or less was obtained', 'armGroupLabels': ['Multiple dose mtx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79761', 'city': 'Bandar Abbas', 'state': 'Hormozgan', 'country': 'Iran', 'facility': 'Shariaty Hospital', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hormozgan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohammad E Shahrzad, MD', 'investigatorAffiliation': 'Hormozgan University of Medical Sciences'}}}}