Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT03362450
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2017-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562456', 'term': 'Volvulus Of Midgut'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011263', 'term': 'Pregnancy Trimester, Third'}, {'id': 'D001344', 'term': 'Autopsy'}], 'ancestors': [{'id': 'D011264', 'term': 'Pregnancy Trimesters'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'echography', 'timeFrame': 'during the second (22-24 weeks) after ultrasound screening', 'description': 'Observation of specific signs using echography for the diagnosis of fetal during the second (22-24 weeks) and the third (31-34 weeks) trimester after ultrasound screening and when diagnostic ultrasound were performedmidgut volvulus'}, {'measure': 'echography', 'timeFrame': 'the third (31-34 weeks) trimester after ultrasound screening', 'description': 'Observation of specific signs using echography for the diagnosis of fetal'}], 'secondaryOutcomes': [{'measure': 'ultrasound signs of complication', 'timeFrame': 'the third (31-34 weeks) after ultrasound screening', 'description': 'Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.'}, {'measure': 'ultrasound signs of complication', 'timeFrame': 'during the second (22-24 weeks) after ultrasound screening', 'description': 'Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.'}, {'measure': 'ultrasound signs of complication', 'timeFrame': '1 day', 'description': 'Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis after diagnostic ultrasound.'}, {'measure': 'ultrasound signs of complication', 'timeFrame': 'just after delivery', 'description': 'Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.'}, {'measure': 'presence or not of the volvulus', 'timeFrame': '1 day', 'description': 'Observation of surgery outcome like presence or not of the volvulus after diagnostic ultrasound'}, {'measure': 'presence or not of the volvulus', 'timeFrame': 'during the second (22-24 weeks) after ultrasound screening', 'description': 'Observation of surgery outcome like presence or not of the volvulus'}, {'measure': 'presence or not of the volvulus', 'timeFrame': 'just after delivery', 'description': 'Observation of surgery outcome like presence or not of the volvulus'}, {'measure': 'presence or not of the volvulus', 'timeFrame': 'the third (31-34 weeks) after ultrasound screening', 'description': 'Observation of surgery outcome like presence or not of the volvulus'}, {'measure': 'presence or not ileal atresia.', 'timeFrame': 'during the second (22-24 weeks) after ultrasound screening', 'description': 'Observation of surgery outcome like presence or not ileal atresia'}, {'measure': 'presence or not ileal atresia.', 'timeFrame': 'the third (31-34 weeks) after ultrasound screening', 'description': 'Observation of surgery outcome like presence or not ileal atresia'}, {'measure': 'presence or not ileal atresia.', 'timeFrame': 'just after delivery', 'description': 'Observation of surgery outcome like presence or not ileal atresia'}, {'measure': 'presence or not ileal atresia.', 'timeFrame': '1 day', 'description': 'Observation of surgery outcome like presence or not ileal atresia after diagnostic ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midgut volvulus', 'Fetal volvulus', 'Whirlpool sign', 'Pregnant women', 'Position of mesenteric vessels', 'Post natal surgery', 'Foetopathology if performed', 'Hydro-meconium level in the dilated loops'], 'conditions': ['Fetal Volvulus', 'Midgut Volvulus']}, 'descriptionModule': {'briefSummary': 'Objective:\n\nThe small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero and whose prenatal diagnosis is difficult.Sonographic signs are mainly indirect and non specific.The aim of this study is to present a retrospective analysis of prenatal sonographicfindings in fetal segmental midgut volvulus.Thanks to this series the investigators could highlight the more specifics signs of the volvulus included a new pattern.', 'detailedDescription': 'Objective:\n\nThe small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero and whose prenatal diagnosis is difficult. Sonographic signs are mainly indirect and nonspecific. The aim of this study is to present a retrospective analysis of prenatal sonographic findings in fetal segmental midgut volvulus. Thanks to this series the investigators could highlight the more specifics signs of the volvulus included a new pattern.\n\nMethods:\n\nUnicentric retrospective analysis of cases of prenatal midgut volvulus between 2006 and 2017. The primary inclusion criteria was postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings. The exclusion criteria was the absence of prenatal imaging assessment. The investigators collected the clinical history and the echographic mode B and color Doppler. They have searched for some specific sign like " whirlpool sign " representing the winding of the mesenteric vein around the superior mesenteric arterywith color Doppler with arciform pattern of the midgut, hydro-meconium level in the dilated loops and position of mesenteric vessels for evaluation of the intestinal (mal) rotation. Gold standard was surgery or foetopathology if performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant women', 'genderDescription': 'All pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings\n\nExclusion Criteria:\n\n* the absence of prenatal imaging assessment'}, 'identificationModule': {'nctId': 'NCT03362450', 'briefTitle': 'Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features', 'orgStudyIdInfo': {'id': 'RECHMPL17_0321'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant patients seen for second or third trimester', 'description': 'Foetus with diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings', 'interventionNames': ['Other: Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination']}], 'interventions': [{'name': 'Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination', 'type': 'OTHER', 'description': 'Fetal ultrasound during the second or third trimester Postnatal surgery Post mortem examination', 'armGroupLabels': ['Pregnant patients seen for second or third trimester']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}