Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT04443205
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2020-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relevance of Ultrasound Screening for Foetal Macrosomia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005320', 'term': 'Fetal Macrosomia'}, {'id': 'D000080883', 'term': 'Shoulder Dystocia'}], 'ancestors': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011254', 'term': 'Pregnancy in Diabetics'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004420', 'term': 'Dystocia'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057286', 'term': 'Electronic Health Records'}], 'ancestors': [{'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foetal macrosomia', 'timeFrame': 'Baseline', 'description': 'estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fetal Macrosomia', 'Ultrasound', 'Shoulder Dystocia', 'induction of labour', 'Cesarean'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.', 'detailedDescription': 'The aim of the study is to describe management of women whose child is macrosomal but has not been screened g using ultrasound during the third trimester of pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria : Patients (consecutive inclusions) :\n\nWomen pregnant Women followed in the gynaecology and obstetrics department of the CHU of Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.\n\nWomen for which the delivery is planned in the gynaecology and obstetrics department of the Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en Champagne General Hospital.\n\nNon-inclusion criteria Women without ultrasound dating scan in the first trimester. Women having a contraindication to labour or vaginal delivery Women with a scarred uterus Women having a history of shoulder dystocia or obstetric trauma Women having a history of urinary or fecal incontinence Women having a history of bad birth experience with high psychological impact Women with maternal pathologies (excluding gestational diabetes) Women whose fetus is breech Women with twin pregnancy'}, 'identificationModule': {'nctId': 'NCT04443205', 'acronym': 'USmacro', 'briefTitle': 'Relevance of Ultrasound Screening for Foetal Macrosomia', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne', 'orgStudyIdInfo': {'id': 'PO20090'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no macrosomy', 'description': 'pregnant women whose child is not macrosomal', 'interventionNames': ['Other: Data record']}, {'label': 'screened macrosomy', 'description': 'pregnant women whose child is macrosomal and have been screened g using ultrasound during the third trimester of pregnancy', 'interventionNames': ['Other: Data record']}, {'label': 'no screened macrosomy', 'description': 'pregnant women whose child is macrosomal and havenot been screened g using ultrasound during the third trimester of pregnancy', 'interventionNames': ['Other: Data record']}], 'interventions': [{'name': 'Data record', 'type': 'OTHER', 'description': 'Data record', 'armGroupLabels': ['no macrosomy', 'no screened macrosomy', 'screened macrosomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'country': 'France', 'contacts': [{'name': 'Uzma ISHAQUE', 'role': 'CONTACT', 'email': 'uishaque@chu-reims.fr', 'phone': '03 10 73 62 88', 'phoneExt': '0033'}], 'facility': 'Damien JOLLY', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Uzma ISHAQUE', 'role': 'CONTACT', 'email': 'uishaque@chu-reims.fr', 'phone': '03 10 73 62 88', 'phoneExt': '0033'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}