Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-04 @ 2:15 PM
Study NCT ID:
NCT01876004
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2013-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Of Expectant Management In The Tubal 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': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of treatment', 'timeFrame': '6 months', 'description': 'β-hCG negative (\\<5 mIU / mL)'}, {'measure': 'Time required for titers of β-hCG to become negative', 'timeFrame': '6 weeks', 'description': 'After medication, monitoring will be done by measurement of β-hCG in the 4th and 7th day. If there ia a decrease \\> 15% in this range (4th and 7th), patient will be followed with weekly dosing of β-hCG until negative titers'}], 'secondaryOutcomes': [{'measure': 'Blood tests before treatment with Methotrexate and Placebo', 'timeFrame': '6 months', 'description': 'Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment'}, {'measure': 'Blood tests after treatment with Methotrexate and Placebo', 'timeFrame': '6 months', 'description': 'Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ectopic pregnancy', 'methotrexate', 'human chorionic gonadotropin beta subunit', 'expectant management'], 'conditions': ['Ectopic Pregnancy']}, 'descriptionModule': {'briefSummary': 'Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was \\> 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodynamic stability\n* Initial β-hCG \\<2000 mIU / mL\n* Titers of β-hCG in decline in 48 hours before treatment\n* Adnexal mass \\<5.0 cm\n* Desire for future pregnancy\n\nExclusion Criteria:\n\n* Alive embryo\n* Ectopic pregnancy other than in tubal location\n* Pregnancy of unknown location'}, 'identificationModule': {'nctId': 'NCT01876004', 'briefTitle': 'Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy', 'orgStudyIdInfo': {'id': 'CEP UNIFESP 0772/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate', 'description': 'Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Prescribed Placebo intramuscularly.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': '50 mg/m2, IM (intramuscularly), single dose', 'armGroupLabels': ['Methotrexate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Prescribed Placebo IM (intramuscularly), single dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Julio Elito Junior', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Luiz Camano', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Obstetrics and Gynecologist', 'investigatorFullName': 'Priscila Matthiesen e Silva', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}