Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04585256
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trendelenburg Positioning and External Cephalic Version Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018475', 'term': 'Head-Down Tilt'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-21', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'External cephalic version success', 'timeFrame': 'Up to 10 minutes from the beginning of external cephalic version.', 'description': 'The rate of successful external cephalic version'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Up to 2 hours from the beginning of external cephalic version.', 'description': 'Visual analog scale scoring from 0-10 during and following the procedure.'}, {'measure': 'Placental abruption', 'timeFrame': 'Up to 1 week from the beginning of external cephalic version.', 'description': 'Rate of clinical placental abruption'}, {'measure': 'Vaginal delivery', 'timeFrame': 'Up to 4 weeks from the beginning of external cephalic version.', 'description': 'Rate of vaginal deliveries'}, {'measure': 'Cesarean delivery', 'timeFrame': 'Up to 4 weeks from the beginning of external cephalic version.', 'description': 'Rate of cesarean deliveries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breech Presentation of Fetus With Successful Version']}, 'descriptionModule': {'briefSummary': 'Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. We will evaluate external cephalic version success and compare the 2 groups.', 'detailedDescription': 'This is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning.\n\nThe women that are eligible for participation will receive a thorough explanation and will sign informed consent.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women interested in having external cephalic version at a gestational age of 37+0/7 or more.\n\nExclusion Criteria:\n\n* Age 18 and under.\n* Women with a body mass index 35 or higher.\n* Women with a previous cesarean section.\n* Women with premature rupture of membranes.\n* Women with vaginal bleeding.\n* Women with a previously failed external cephalic version.'}, 'identificationModule': {'nctId': 'NCT04585256', 'briefTitle': 'Trendelenburg Positioning and External Cephalic Version Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Effect of Trendelenburg Positioning on External Cephalic Version Outcome', 'orgStudyIdInfo': {'id': '0145-20-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trendelenburg', 'description': 'Women positioned in the trendelenburg position during external cephalic version.', 'interventionNames': ['Other: Trendelenburg positioning']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Women positioned on their back during external cephalic version.'}], 'interventions': [{'name': 'Trendelenburg positioning', 'type': 'OTHER', 'description': 'Women positioned in the trendelenburg position prior to external cephalic version', 'armGroupLabels': ['Trendelenburg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Roy Lauterbach, MD', 'role': 'CONTACT', 'email': 'r_lauterbach@rambam.health.gov.il', 'phone': '0529432416'}], 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Roy Lauterbach, MD', 'role': 'CONTACT', 'email': 'r_lauterbach@rmc.gov.il', 'phone': '+972-52-9432416'}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam healthcare campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ROY LAUTERBACH MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}