Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01107158
Status:
TERMINATED
Last Update Posted:
2025-11-19
First Post:
2010-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LXRs, Cholesterol Metabolism and Uterine Dystocia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014593', 'term': 'Uterine Inertia'}, {'id': 'D004420', 'term': 'Dystocia'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A whole blood sample is taken and DNA extracted using Qiagen kits.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Inclusion curve too slow.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The multi-loci genotype of the target DNA sequence.', 'timeFrame': 'Day 1', 'description': 'The polymorphisms of interest are the following SNPs: rs3758673, rs3758674, rs12221497, rs11039155, rs2279238, rs7120118, rs35463555, rs1052533, rs2248949, rs41432149, rs1405655, rs4802703.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Inertia', 'Dystocia']}, 'referencesModule': {'references': [{'pmid': '27510420', 'type': 'RESULT', 'citation': 'Mouzat K, Raoul C, Polge A, Kantar J, Camu W, Lumbroso S. Liver X receptors: from cholesterol regulation to neuroprotection-a new barrier against neurodegeneration in amyotrophic lateral sclerosis? Cell Mol Life Sci. 2016 Oct;73(20):3801-8. doi: 10.1007/s00018-016-2330-y. Epub 2016 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'Despite the fact that a link between cholesterol and the myometrium has been clearly established, no study investigating aspects of cholesterol metabolism and uterine dystocia currently exists. This study is a pilot study whose aim is to test the hypothesis that an association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes coding for the LXRs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population represents women undergoing a difficult, stagnating labor due to either physical or uterine dystocia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing C-section for a dystocia: 2 to 3 hours of stagnation in labor progress are observed (ie no increasing dilation, and uterine contractions less that 3-5 per 10 minutes) in spite of measures taken to overcome dystocia (oxytocin injection and artificial breaking of waters)\n* the child is alive\n* the child does not have apriori known malformations that could interfere with a vaginal birth\n* foetus in cephalic position\n* full term pregnancy (\\>= 37 weeks of amenorrhea)\n* single birth\n* patient has signed consent\n* patient is affiliated with a social security system\n\nExclusion Criteria:\n\n* vaginal birth\n* programmed C-section\n* C-section is chosen because the fetus has a cardia rhythm problem, and there is no stagnation in the labor process\n* multiple pregnancy\n* the child is in a breech position\n* premature birth (\\<37 weeks amenorrhea)\n* in utero fetal death\n* fetal malformation known before birth that could interfere with a vaginal birth\n* non french-speaking patient (impossible to correctly inform the patient)\n* patient under guardianship'}, 'identificationModule': {'nctId': 'NCT01107158', 'briefTitle': 'LXRs, Cholesterol Metabolism and Uterine Dystocia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta', 'orgStudyIdInfo': {'id': 'AOI/2009/KM-01'}, 'secondaryIdInfos': [{'id': '2009-A00968-49', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Control group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved.', 'interventionNames': ['Biological: Whole blood sampling']}, {'label': 'Group 2', 'description': 'These patients have uterine dystocia', 'interventionNames': ['Biological: Whole blood sampling']}], 'interventions': [{'name': 'Whole blood sampling', 'type': 'BIOLOGICAL', 'description': 'Whole blood sampling for SNP polymorphism analysis', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Kevin Mouzat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}