Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 11:33 AM
Study NCT ID:
NCT04579835
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001946', 'term': 'Breech Presentation'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014710', 'term': 'Version, Fetal'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-01', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of external cephalic version Twin A', 'timeFrame': '4 hours after external cephalic version', 'description': 'Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants'}], 'secondaryOutcomes': [{'measure': 'Fetal weight', 'timeFrame': '30 Minutes before external cephalic version', 'description': 'Measurement in grams'}, {'measure': 'Fetal Doppler Umbilical Pulsatility Index', 'timeFrame': '30 Minutes before external cephalic version', 'description': 'Index mesurent /Ratio'}, {'measure': 'Fetal Doppler Umbilical Resistance Index', 'timeFrame': '30 Minutes before external cephalic version', 'description': 'Index mesurent /Ratio'}, {'measure': 'Incidence of pathological cardiotocogramm', 'timeFrame': '60 Minutes after external cephalic version', 'description': 'Numerical percentage'}, {'measure': 'Incidence of emergency delivery', 'timeFrame': '60 Minutes after external cephalic version', 'description': 'Numerical percentage'}, {'measure': 'Incidence of bleeding', 'timeFrame': '60 Minutes after external cephalic version', 'description': 'Numerical percentage'}, {'measure': 'Incidence of contractions', 'timeFrame': '60 Minutes after external cephalic version', 'description': 'Numerical percentage'}, {'measure': 'Incidence of rupture of membranes', 'timeFrame': '60 Minutes after external cephalic version', 'description': 'Numerical percentage'}, {'measure': 'Pain scores', 'timeFrame': '60 Minutes after external cephalic version', 'description': 'Numerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful)'}, {'measure': 'Mode of Delivery', 'timeFrame': '6 weeks after delivery', 'description': 'Type of delivery (vaginal or caesarean)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breech Presentation', 'Twin; Complicating Pregnancy']}, 'descriptionModule': {'briefSummary': 'A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.', 'detailedDescription': 'The primary goal of the study is to determine the success rate of Twin A external Cephalic Version in our obstetric clinic and to determine new favorable sonographic criteria associated with a successful attempt that have not been investigated before.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting with Twin A breech presentation to the antenatal clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of the written consent of the patients.\n* The patients must be over 18 years old .\n* No limit in the ability to consent.\n\nExclusion Criteria:\n\n* Age under 18\n* Limited ability to consent\n* Placenta previa\n* Fetal abnormalities'}, 'identificationModule': {'nctId': 'NCT04579835', 'acronym': 'TWEXIT', 'briefTitle': 'Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Twin A Breech External Cephalic Version Intervention Trial', 'orgStudyIdInfo': {'id': 'EA2/116/20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'External Cephalic Version', 'type': 'OTHER', 'description': 'External Cephalic Version Twin A'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Mitte', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Larry Hinkson, FRCOG', 'role': 'CONTACT'}], 'facility': 'Charité University Hospital', 'geoPoint': {'lat': 52.52003, 'lon': 13.40489}}], 'centralContacts': [{'name': 'Larry Hinkson, FRCOG', 'role': 'CONTACT', 'email': 'Larry.Hinkson@charite.de', 'phone': '004930450664710'}], 'overallOfficials': [{'name': 'Larry Hinkson, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lead Consultant in Obstetrics, Deputy Director', 'investigatorFullName': 'Larry Hinkson', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}