Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 1:18 PM
Study NCT ID:
NCT03797833
Status:
SUSPENDED
Last Update Posted:
2022-10-27
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Anesthesia for External Cephalic Version
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001946', 'term': 'Breech Presentation'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Slow inclusion rate. Central contact person quit for another job.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'External version success rate', 'timeFrame': '1 hour', 'description': 'Rate of successful version as assessed by gynaecologist after maximum three attempts.'}], 'secondaryOutcomes': [{'measure': 'Overall maternal satisfaction post external version attempt', 'timeFrame': '1 hour', 'description': 'Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts.'}, {'measure': 'Overall maternal satisfaction post partum', 'timeFrame': '3 months', 'description': 'Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum)'}, {'measure': 'Caesarian section rate', 'timeFrame': '1 months', 'description': 'The mode of delivery, assessed from the medical charts after delivery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breech presentation, external version, spinal anaesthesia'], 'conditions': ['Breech Presentation; Before Labor']}, 'referencesModule': {'references': [{'pmid': '25962611', 'type': 'BACKGROUND', 'citation': 'Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10.'}, {'pmid': '27131581', 'type': 'BACKGROUND', 'citation': 'Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27.'}, {'pmid': '25674710', 'type': 'BACKGROUND', 'citation': 'Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4.'}, {'pmid': '28723831', 'type': 'BACKGROUND', 'citation': 'Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.', 'detailedDescription': "Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.\n\nThe primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.\n\nThe secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant nulliparous women.\n* Breech presentation of fetus, eligible for external version.\n\nExclusion Criteria:\n\n* Unwilling to participate.\n* Unable to understand written and oral Swedish in the absence of interpreter.\n* Contraindications to spinal anaesthesia.'}, 'identificationModule': {'nctId': 'NCT03797833', 'briefTitle': 'Spinal Anesthesia for External Cephalic Version', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study', 'orgStudyIdInfo': {'id': '2018/634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard treatment', 'description': 'ECV according to standard practice.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal anaesthesia', 'description': 'ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg)', 'interventionNames': ['Procedure: Spinal Anaesthesia']}], 'interventions': [{'name': 'Spinal Anaesthesia', 'type': 'PROCEDURE', 'description': 'Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg', 'armGroupLabels': ['Spinal anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Andreas Herbst, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}