Ignite Creation Date:
2025-12-24 @ 7:31 PM
Ignite Modification Date:
2025-12-29 @ 11:42 PM
Study NCT ID:
NCT01033903
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2009-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Treatment of Miscarriage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}], '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': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete miscarriage', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'complete miscarriage', 'timeFrame': '17 days, 24 days, 31 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abortion, Spontaneous', 'Randomized Controlled Trial'], 'conditions': ['Abortion, Spontaneous']}, 'referencesModule': {'references': [{'pmid': '29072372', 'type': 'DERIVED', 'citation': 'Fernlund A, Jokubkiene L, Sladkevicius P, Valentin L. Misoprostol treatment vs expectant management in women with early non-viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jan;51(1):24-32. doi: 10.1002/uog.18940. Epub 2017 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nonviable intrauterine pregnancy with retained gestational sac in the uterus\n* the embryo if visible 5 to 35 mm without a heart beat\n* vaginal bleeding\n* circulatory stable\n* hemoglobin at least 80 g/L\n\nExclusion Criteria:\n\n* contraindications against misoprostol'}, 'identificationModule': {'nctId': 'NCT01033903', 'briefTitle': 'Optimal Treatment of Miscarriage', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Which is the Optimal Treatment for Miscarriage With a Gestational ac in the Uterus and Which Factors Can Predict if the Treatment Will be Successful?', 'orgStudyIdInfo': {'id': 'EudraCT 2007-007661-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol 800 micrograms intravaginally', 'interventionNames': ['Drug: misoprostol']}, {'type': 'NO_INTERVENTION', 'label': 'expectant managment'}], 'interventions': [{'name': 'misoprostol', 'type': 'DRUG', 'description': '800 micrograms intravaginally ONCE', 'armGroupLabels': ['Misoprostol 800 micrograms intravaginally']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Region Skane, Kvinnokliniken, University Hopsital MAS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}