Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-01 @ 7:16 AM
Study NCT ID:
NCT04981457
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Combined Vaginal Misoprostol
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-01', 'size': 1082451, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-24T06:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induction to abortion interval', 'timeFrame': '6 months', 'description': "Induction to abortion interval: the Duration interval between the beginning of the induction and beginning of cervical ripening assessed by cervical examination(cervix become soft and start to dilate) and uterine contractions leading to complete expulsion of the abortus spontaneous and if cervical ripening isn't occur by maximum doses the investigators will make surgical evacuation."}, {'measure': 'Number of the doses', 'timeFrame': '6 months', 'description': 'the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Missed Abortion']}, 'referencesModule': {'references': [{'pmid': '16305563', 'type': 'BACKGROUND', 'citation': 'Arteaga-Troncoso G, Villegas-Alvarado A, Belmont-Gomez A, Martinez-Herrera FJ, Villagrana-Zesati R, Guerra-Infante F. Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomised controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception. BJOG. 2005 Dec;112(12):1615-9. doi: 10.1111/j.1471-0528.2005.00760.x.'}, {'pmid': '30253769', 'type': 'BACKGROUND', 'citation': 'Carlsson I, Breding K, Larsson PG. Complications related to induced abortion: a combined retrospective and longitudinal follow-up study. BMC Womens Health. 2018 Sep 25;18(1):158. doi: 10.1186/s12905-018-0645-6.'}, {'pmid': '28138973', 'type': 'BACKGROUND', 'citation': 'Kim C, Barnard S, Neilson JP, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database Syst Rev. 2017 Jan 31;1(1):CD007223. doi: 10.1002/14651858.CD007223.pub4.'}]}, 'descriptionModule': {'briefSummary': '"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate', 'detailedDescription': '"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate versus Misoprostol Alone For Induction Of The first trimester Missed Abortion A Randomized Clinical Trial"'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Maternal Age 18 - 35 years.\n* Gestational age first trimester of pregnancy (between 5-13 weeks).\n* Missed abortion confirmed by ultrasound.\n* Singleton pregnancy.\n* Normal uterus and cervix on clinical examination.\n* Cervix is not dilated.\n* No vaginal bleeding.\n\nExclusion Criteria:- Evidences suggesting start of spontaneous abortion and previous trial to induce abortion.\n\n* Presence of uterine contraction or bleeding,\n* Multi-fetal pregnancy.\n* Suspicion of septic abortion.\n* History of Previous cervical surgery or manipulation. Ex: cervical tear , cervical cauterization .\n* Uterine anomaly.\n* Presence of IUD( intrauterine device) in situ\n* Underlying medical diseases.Ex:diabetes mellitus,hypertension\n* History of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate\n* Those unwilling to participate in the trial\n* Higher order cesarean section(more than three'}, 'identificationModule': {'nctId': 'NCT04981457', 'acronym': 'comparative', 'briefTitle': 'Comparative Study Between Combined Vaginal Misoprostol', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between Combined Vaginal Misoprostol With Isosorbide-5-Mononitrate Versus Misoprostol Alone For Induction Of The First Trimester Missed Abortion A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MS-196-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients who recieve misoprostol alone', 'description': 'Group A (n =30 ) will receive only vaginal Misoprostol 800mcg (4 tablets Cytotec 200mcg ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or uterine contractions or bleeding assessed by the same doctor who made evaluation at the beginning.', 'interventionNames': ['Drug: Misoprostol and iso sorbide mononitrates']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patients who recieve misoprostol and iso sorbide mononitrate', 'description': 'Group B (n =30 ) will receive combined vaginal Misoprostol 800mcg (4 tablets Cytotec ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or start of uterine contractions or bleeding. with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning with misoprostol until reaching cervical ripening or start of and uterine contractions assessed by the same doctor who made the evaluation at the beginning.', 'interventionNames': ['Drug: Misoprostol and iso sorbide mononitrates']}], 'interventions': [{'name': 'Misoprostol and iso sorbide mononitrates', 'type': 'DRUG', 'otherNames': ['misotac and effox'], 'description': 'drug', 'armGroupLabels': ['patients who recieve misoprostol alone', 'patients who recieve misoprostol and iso sorbide mononitrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'state': 'Married', 'country': 'Egypt', 'facility': 'Cairo U', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mohamed shalaby, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo u'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of obstetrics and gynacology', 'investigatorFullName': 'Kholod Mohamed Mahmoud Mousa Elkholy', 'investigatorAffiliation': 'Cairo University'}}}}