Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT00190294
Status:
COMPLETED
Last Update Posted:
2011-05-02
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-29', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of surgical evacuation in each group', 'timeFrame': 'during de study', 'description': 'Number of surgical evacuation in each group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy Complications'], 'conditions': ['Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '34061352', 'type': 'DERIVED', 'citation': 'Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.'}, {'pmid': '22381604', 'type': 'DERIVED', 'citation': 'Torre A, Huchon C, Bussieres L, Machevin E, Camus E, Fauconnier A. Immediate versus delayed medical treatment for first-trimester miscarriage: a randomized trial. Am J Obstet Gynecol. 2012 Mar;206(3):215.e1-6. doi: 10.1016/j.ajog.2011.12.009. Epub 2011 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.', 'detailedDescription': 'Randomized control trial comparing one week expectancy vs immediate medical treatment (mifepristone 200mg and misoprostol 400ug) in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agreed women aged over 18 yrs old\n\nNon evolutive pregnancy before 13GW :\n\n* Non evolutive pregnancy with no fetal cardiac activity\n* Non evolutive pregnancy with embryonic structures\n* Trophoblastic material in uterine cavity P bhCG \\< 10UI/L\n\nExclusion criteria:\n\n* Age \\< 18 years\n* pregnancy evolutionary\n* not evolutionary pregnancy after 13 weeks of amenorrhoea characterized by the presence of an scan image intra-uterine ANECHOGENE furthermore of 50mm of diameter\n* amenorrhoea of more than 13 weeks\n* pregnancy twin\n* pregnancy molar\n* pregnancy extra-uterine\n* Extra-uterine pregnancy\n* one or many contraindications in the mifepristone:\n* Allergy known about the MIFEPRISTONE\n* Incapacity suprarenal\n* corticosteroid therapy in the long price\n* confusions of the haemostasis (thrombopenia \\< in 100000 / mm3)\n* anaemia (rate Hg \\< in 9 g / dl)\n* contraindication in the misoprostol\n* allergy known about PROSTAGLANDINES\n* BEANCE cervical'}, 'identificationModule': {'nctId': 'NCT00190294', 'briefTitle': 'Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW', 'orgStudyIdInfo': {'id': 'P011017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MIFEPRISTONE 200 mg and misoprostol 400 µg', 'interventionNames': ['Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg']}], 'interventions': [{'name': 'MIFEPRISTONE 200 mg and misoprostol 400 µg', 'type': 'DRUG', 'description': 'MIFEPRISTONE 200 mg and misoprostol 400 µg', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78303', 'city': 'Poissy', 'country': 'France', 'facility': 'Poissy Hospital', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}], 'overallOfficials': [{'name': 'Patrick Rosenberg', 'role': 'STUDY_CHAIR', 'affiliation': 'Poissy Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Isabelle Brindel', 'oldOrganization': 'Department Clinical Research of developpement'}}}}