Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
Study NCT ID:
NCT00835003
Status:
COMPLETED
Last Update Posted:
2014-07-03
First Post:
2009-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Timing of Planned Caesarean Section and Morbidity of the Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017558', 'term': 'Elective Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'julie.glavind@dadlnet.dk', 'phone': '+4578450000', 'title': 'MD, PhD Julie Glavind', 'organization': 'Aarhus University Hospital, Dep. Obstetrics and Gynecology, Aarhus, Denmark'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': '38 Weeks Group', 'description': 'Elective caesarean section at 38 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)', 'otherNumAtRisk': 636, 'otherNumAffected': 0, 'seriousNumAtRisk': 636, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '39 Weeks Group', 'description': 'Elective caesarean section at 39 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)', 'otherNumAtRisk': 638, 'otherNumAffected': 0, 'seriousNumAtRisk': 638, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Fetal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 636, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 638, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 636, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 638, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neonatal Admission After Elective Caesarean Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '38 Weeks Group', 'description': 'Elective caesarean section at 38 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)'}, {'id': 'OG001', 'title': '39 Weeks Group', 'description': 'Elective caesarean section at 39 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group'}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Diagnoses', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Satisfaction With Timing of Elective Caesarean Section', 'timeFrame': '2 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Post Partum Depression', 'timeFrame': '2 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Pediatric Admission and Morbidity', 'timeFrame': '2 months post partum', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Pediatric Admission and Morbidity', 'timeFrame': 'From birth until 2 years of age', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '38 Weeks Group', 'description': 'Elective caesarean section at 38 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)'}, {'id': 'FG001', 'title': '39 Weeks Group', 'description': 'Elective caesarean section at 39 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '636'}, {'groupId': 'FG001', 'numSubjects': '638'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '636'}, {'groupId': 'FG001', 'numSubjects': '638'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '636', 'groupId': 'BG000'}, {'value': '638', 'groupId': 'BG001'}, {'value': '1274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '38 Weeks Group', 'description': 'Elective caesarean section at 38 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)'}, {'id': 'BG001', 'title': '39 Weeks Group', 'description': 'Elective caesarean section at 39 weeks and 3 days of gestation\n\nElective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '31.8', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '636', 'groupId': 'BG000'}, {'value': '638', 'groupId': 'BG001'}, {'value': '1274', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '636', 'groupId': 'BG000'}, {'value': '638', 'groupId': 'BG001'}, {'value': '1274', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1273}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2009-02-02', 'resultsFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-03', 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal Admission After Elective Caesarean Section', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Neonatal Diagnoses', 'timeFrame': '30 days'}, {'measure': 'Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics', 'timeFrame': '30 days'}, {'measure': 'Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.', 'timeFrame': '30 days'}, {'measure': 'Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission', 'timeFrame': '30 days'}, {'measure': 'Maternal Satisfaction With Timing of Elective Caesarean Section', 'timeFrame': '2 months'}, {'measure': 'Post Partum Depression', 'timeFrame': '2 months'}, {'measure': 'Pediatric Admission and Morbidity', 'timeFrame': '2 months post partum'}, {'measure': 'Pediatric Admission and Morbidity', 'timeFrame': 'From birth until 2 years of age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neonatal admission', 'Elective Caesarean Section', 'Timing', 'Choice behavior', 'Intraoperative complications', 'Postoperative complications'], 'conditions': ['Respiratory Disorders', 'Intensive Care, Neonatal']}, 'referencesModule': {'references': [{'pmid': '24376842', 'type': 'DERIVED', 'citation': 'Glavind J, Henriksen TB, Kindberg SF, Uldbjerg N. Randomised trial of planned caesarean section prior to versus after 39 weeks: unscheduled deliveries and facility logistics--a secondary analysis. PLoS One. 2013 Dec 20;8(12):e84744. doi: 10.1371/journal.pone.0084744. eCollection 2013.'}, {'pmid': '23682628', 'type': 'DERIVED', 'citation': 'Glavind J, Kindberg SF, Uldbjerg N, Khalil M, Moller AM, Mortensen BB, Rasmussen OB, Christensen JT, Jorgensen JS, Henriksen TB. Elective caesarean section at 38 weeks versus 39 weeks: neonatal and maternal outcomes in a randomised controlled trial. BJOG. 2013 Aug;120(9):1123-32. doi: 10.1111/1471-0528.12278. Epub 2013 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The caesarean section rate is rising globally. About 10% of the newborns are submitted to a neonatal department after planned caesarean section, primarily with respiratory disorders. More children are submitted if caesarean is performed earlier in pregnancy.\n\nStudy hypothesis: More newborns are admitted after planned caesarean at 38 weeks and 3 days of gestation than after 39 weeks and 3 days of gestation.\n\nAim of study: To compare elective caesarean section performed at 38 weeks and 3 days of gestation with 39 weeks and 3 days of gestation. According to this timing to determine the proportion of newborns admitted within 48 hours after birth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective caesarean section\n* Gestational age determined at 12 weeks ultrasound scan\n* Singleton pregnancy\n\nExclusion Criteria:\n\n* \\< 18 years of age (at time of randomization)\n* In need of an interpreter to communicate in danish\n* Diabetes, both gestational and before pregnancy\n* A mother with an estimated high risk of caesarean section before 39+5 weeks'}, 'identificationModule': {'nctId': 'NCT00835003', 'briefTitle': 'Timing of Planned Caesarean Section and Morbidity of the Newborn', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study', 'orgStudyIdInfo': {'id': 'AAUH091077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Elective caesarean section at 38 weeks and 3 days of gestation', 'interventionNames': ['Procedure: Elective caesarean section']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Elective caesarean section at 39 weeks and 3 days of gestation', 'interventionNames': ['Procedure: Elective caesarean section']}], 'interventions': [{'name': 'Elective caesarean section', 'type': 'PROCEDURE', 'otherNames': ['Elective surgery', 'Planned caesarean section'], 'description': 'Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)', 'armGroupLabels': ['1']}, {'name': 'Elective caesarean section', 'type': 'PROCEDURE', 'otherNames': ['Elective surgery', 'Planned caesarean section'], 'description': 'Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Odense', 'country': 'Denmark', 'facility': 'University Hospital of Odense', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Regional Hospital of Herning', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'facility': 'Hospital of Kolding', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'zip': '8930', 'city': 'Randers', 'country': 'Denmark', 'facility': 'Regional Hospital of Randers', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Regional Hospital of Viborg', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Julie Glavind, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby'}, {'name': 'Niels Uldbjerg, MD,Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby'}, {'name': 'Tine B Henriksen, MD, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Neonatal Department, Aarhus University Hospital Skejby'}, {'name': 'Sara F Kindberg, PhD, midwife', 'role': 'STUDY_CHAIR', 'affiliation': 'Perinatal Research Unit, Aarhus University Hospital Skejby'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Julie Glavind', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}