Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
Study NCT ID:
NCT00222066
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2005-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'C536396', 'term': 'Neonatal ovarian cyst'}, {'id': 'D000082843', 'term': 'Ovarian Torsion'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014102', 'term': 'Torsion Abnormality'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2005-09-19', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To avoid neonatal surgery', 'timeFrame': '3 months after birth'}], 'secondaryOutcomes': [{'measure': 'Ultrasound pattern of neonatal ovarian cyst', 'timeFrame': '3 months after birth'}, {'measure': 'Maternal and fetal/neonatal safety of prenatal ovarian cyst aspiration', 'timeFrame': '3 months after birth'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aspiration', 'Fetal ovarian cyst', 'Ovarian torsion'], 'conditions': ['Ovarian Cyst', 'Ultrasonography Prenatal']}, 'referencesModule': {'references': [{'pmid': '11169374', 'type': 'BACKGROUND', 'citation': 'Perrotin F, Potin J, Haddad G, Sembely-Taveau C, Lansac J, Body G. Fetal ovarian cysts: a report of three cases managed by intrauterine aspiration. Ultrasound Obstet Gynecol. 2000 Dec;16(7):655-9. doi: 10.1046/j.1469-0705.2000.00247.x.'}, {'pmid': '10790628', 'type': 'BACKGROUND', 'citation': 'Perrotin F, Roy F, Potin J, Lardy H, Lansac J, Body G. [Ultrasonographic diagnosis and prenatal management of fetal ovarian cysts]. J Gynecol Obstet Biol Reprod (Paris). 2000 Apr;29(2):161-9. French.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion.', 'detailedDescription': 'With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women having an uneventful single pregnancy and a female fetus diagnosed with anechoic ovarian cyst (diameter at least 30mm)\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Complicated pregnancy (PE, diabetes, PROM, fetal malformation)\n* Echoic cyst (fluid debris level, septated, retracting clot, globally echoic)\n* Unability to give informed consent'}, 'identificationModule': {'nctId': 'NCT00222066', 'briefTitle': 'Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion', 'orgStudyIdInfo': {'id': 'OV-UTERO 2000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Fetal ovarian cyst aspiration performed as soon as possible', 'interventionNames': ['Procedure: Fetal ovarian cyst aspiration']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Expectative'}], 'interventions': [{'name': 'Fetal ovarian cyst aspiration', 'type': 'PROCEDURE', 'description': 'Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'state': 'Centre-Val de Loire', 'country': 'France', 'facility': 'Olympe de Gouges Women Health Centre, Bretonneau University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Loire Atl', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Franck Perrotin, MD--PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tours University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr Franck Perrotin', 'oldOrganization': 'CHRU de Tours'}}}}