Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT04422067
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2020-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010855', 'term': 'Pierre Robin Syndrome'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility of cephalometry', 'timeFrame': 'During ultrasound', 'description': 'Reproducibility of cephalometry'}], 'secondaryOutcomes': [{'measure': 'Perfomance of several angle to diagnose retrognatism', 'timeFrame': 'During ultrasound', 'description': 'Perfomance of several angle to diagnose retrognatism'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['with one or more fetuses suffering from a microretrognathia', 'Cephalometry', 'Prenatal Diagnosis', 'Facial angles', 'Fetal echography', 'Microretrognathia', 'diagnosed prenatally'], 'conditions': ['Pierre Robin Sequence']}, 'descriptionModule': {'briefSummary': 'Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.\n\nThe aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pregnant patient (Aged \\>18years old)\n* with one or more fetuses suffering from a microretrognathia\n* diagnosed prenatally\n* integrated into a Pierre Robin Sequence\n\nExclusion criteria:\n\n* Uncvertain diagnosis\n* Absence of 3D rendering volume'}, 'identificationModule': {'nctId': 'NCT04422067', 'briefTitle': 'Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal', 'orgStudyIdInfo': {'id': 'RECHMPL20_0295'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group (Retrognatism)', 'description': 'All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence, were included. All cases were confirmed postnatally, either by a pediatric examination or by a fetopathological examination in the case of a medical termination of the pregnancy. We had 21 cases.', 'interventionNames': ['Other: Fetal cephalometry']}, {'label': 'Control group', 'description': '47 pregnant patients with fetus without facial abnormalities', 'interventionNames': ['Other: Fetal cephalometry']}], 'interventions': [{'name': 'Fetal cephalometry', 'type': 'OTHER', 'description': 'Fetal cephalometry', 'armGroupLabels': ['Case group (Retrognatism)', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Florent FUCHS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}