Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT05208034
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Treatment in Ectopic Tubal 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate', 'timeFrame': '4-14 days', 'description': 'In single-dose group,β-hCG levels were measured at day-4 and 7 and if β-hCG decreased \\>15% between day-4 and day-7, the treatment was labeled successful.\n\nIn two-dose group, in case 15% reduction in β-hCG level was observed at day-14, the treatment was labeled as success.'}], 'secondaryOutcomes': [{'measure': 'frequency of Side-effects of treatment', 'timeFrame': '1-14 days', 'description': 'monitoring for the side effects during the treatment duration'}, {'measure': 'β-hCG Resolution Time', 'timeFrame': '1-14 days', 'description': 'Time taken for β-hcg resolution to reduce below 15%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ectopic Pregnancy']}, 'descriptionModule': {'briefSummary': 'Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.', 'detailedDescription': 'Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.\n\nA new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of tubal ectopic pregnancy.\n* Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.\n* Gestational sac with largest diameter as 4cm.\n* Willing to take methotrexate treatment.\n* Willing to follow up.\n\nExclusion Criteria:\n\n* Heterotrophic pregnancy\n* Persistent tubal pregnancy\n* Embryonic cardiac motion\n* Suspected tubal rupture\n* Past history of harmful effects of methotrexate treatment on organ functions.'}, 'identificationModule': {'nctId': 'NCT05208034', 'briefTitle': 'Medical Treatment in Ectopic Tubal Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Nishtar Medical University'}, 'officialTitle': 'Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy', 'orgStudyIdInfo': {'id': 'NishtarMU12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'single-dose group', 'description': 'Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment).'}, {'type': 'EXPERIMENTAL', 'label': 'two-dose group', 'description': 'Women allocated to two-dose group were administered intramuscular methotrexate as 50mg/m2 at day-zero and 7 while measurement of β-hCG was ordered at day-14.', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.', 'armGroupLabels': ['two-dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66000', 'city': 'Multan Khurd', 'state': 'Pu', 'country': 'Pakistan', 'facility': 'Nishtar Medical University Hospital', 'geoPoint': {'lat': 33.03555, 'lon': 72.01752}}], 'overallOfficials': [{'name': 'Rashida Parveen, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nishtar Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nishtar Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Gynecologist', 'investigatorFullName': 'Rashida Parveen', 'investigatorAffiliation': 'Nishtar Medical University'}}}}