Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04500002
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2020-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007538', 'term': 'Isoniazid'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind randomized parallel assign controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blind randomized parallel assign controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2020-08-02', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with complete abortion', 'timeFrame': '12 hours', 'description': 'number of patients with complete abortion'}, {'measure': 'time from induction to abortion', 'timeFrame': '12 hours', 'description': 'time from induction to abortion'}], 'secondaryOutcomes': [{'measure': 'number of the women will undergo dilatation and curettage after failed medical induction of abortion', 'timeFrame': '12 hours', 'description': 'number of the women will undergo dilatation and curettage after failed medical induction of abortion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IUCD Complication']}, 'descriptionModule': {'briefSummary': 'The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.', 'detailedDescription': 'According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 10 weeks based on the last menstrual period\n\nOral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week\n\nAdjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of complete abortion'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women with gestational age of less than 10 week', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age less than 70 days gestation (\\<10 wks)\n* Hemoglobin \\>10 g/dL.\n* BMI between 18.5 kg/m2 and 30 kg/m2.\n* Missed abortion\n\nExclusion Criteria:\n\n* Molar pregnancy.\n* Fibroid uterus.\n* Uterine anomalies.\n* Coagulopathy.\n* Medical disorder that contraindicate induction of abortion (e.g. heart failure).\n* Previous attempts for induction of abortion in the current pregnancy.\n* Allergy to misoprostol or letrozole.\n* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).'}, 'identificationModule': {'nctId': 'NCT04500002', 'briefTitle': 'Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Adjuvant Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/354/3/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INH', 'description': '3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily doses, 5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum three doses.', 'interventionNames': ['Drug: Isonicotinic Acid Hydrazide', 'Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol', 'description': 'Misoprostol Alone 800 mcg every three hours up to maximum three doses', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Isonicotinic Acid Hydrazide', 'type': 'DRUG', 'description': 'total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion', 'armGroupLabels': ['INH']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': 'Misoprosrol 800mcg will be given to all patients for induction of abortion', 'armGroupLabels': ['INH', 'Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'hany f Sallam, md', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '+20102435461', 'phoneExt': '002'}, {'name': 'nahla waer Shady', 'role': 'CONTACT', 'email': 'hanygyne@yahoo.com', 'phone': '+201022336052', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A Professor', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}