Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00797693
Status:
COMPLETED
Last Update Posted:
2008-11-25
First Post:
2008-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Misoprostol in Termination of First Trimester Missed Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D000030', 'term': 'Abortion, Missed'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-24', 'studyFirstSubmitDate': '2008-11-21', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Higher patient satisfaction for self administered oral misoprostol at home', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['First trimester', 'missed abortion', 'misoprostol', 'cervical ripening', 'oral', 'vaginal', 'first trimester missed abortion'], 'conditions': ['Miscarriage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes.', 'detailedDescription': 'Objective: To compare the effectiveness of oral versus vaginal misoprostol prior to surgical termination of first trimester missed abortion as cervical priming agent , the difference of cervical dilatation immediately prior to operation , the duration of operation and side effects between two treatment groups.\n\nDesign: This study was conducted as randomised study.\n\nSetting: Maternity Teaching Hospital in Hawler/ Kurdistan/ Iraq.\n\nPopulation: Over a period of six months from the first of January to the thirtieth of June, 2008, one hundred women were included in this study. They were cases of first trimester abortion (6-12 weeks).\n\nMethod: Patients were randomly selected for the type of treatment they received. The first group (oral) were assigned to receive 400 micrograms of misoprostol orally as preoperative cervical priming agent, where as the second group (vaginal) were allocated to have treatment either with vaginal misoprostol to receive 400 micrograms vaginally.\n\nMain outcome measure: Oral versus vaginal misoprostol as cervical ripening agent prior to termination of first trimester missed abortion.\n\nKeywords: First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients were cases of first trimester missed abortion.\n* They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus.\n\nExclusion Criteria:\n\n* Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT00797693', 'briefTitle': 'Misoprostol in Termination of First Trimester Missed Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Hawler Medical University'}, 'officialTitle': 'Oral Versus Vaginal Misoprostol as Cervical Ripening Agent Prior to Surgical Termination of First Trimester Missed Abortions in Hawler Maternity Teaching Hospital in Erbil/Iraq', 'orgStudyIdInfo': {'id': '324/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal Misoprostol', 'description': 'A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix', 'interventionNames': ['Drug: Misoprostol ( Cytotec) 200 microgram a tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Misoprostol', 'description': 'A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix', 'interventionNames': ['Drug: Misoprostol ( Cytotec) 200 microgram a tablet']}], 'interventions': [{'name': 'Misoprostol ( Cytotec) 200 microgram a tablet', 'type': 'DRUG', 'otherNames': ['PHARMACIA CORPORATION - Istanbul, serial number 022-00', '200 microgram a tablet'], 'description': 'In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.', 'armGroupLabels': ['Oral Misoprostol', 'Vaginal Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '964', 'city': 'Erbil', 'state': 'Erbil', 'country': 'Iraq', 'facility': 'Maternity Teaching Hospital', 'geoPoint': {'lat': 36.19117, 'lon': 44.00943}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hawler Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'HAWLER Maternity Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Scientific Committe', 'oldOrganization': 'Hawler Medical University'}}}}