Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-04 @ 3:48 PM
Study NCT ID:
NCT03098966
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2017-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rehababdulrahman.rm@gmail.com', 'phone': '+201004992772', 'title': 'Dr.Rehab Mohamed Abdelrahman', 'organization': 'Ain Shams University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'Trials of Labor After Previous Cesarean Section was performed and Adverse Events were assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Trial Of Labour After Caesarean Section', 'description': 'The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:\n\n-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy\n\n-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any\n\n-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)\n\n-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality', 'otherNumAtRisk': 368, 'otherNumAffected': 0, 'seriousNumAtRisk': 368, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Successful Vaginal Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trial Of Labour After Caesarean Section', 'description': 'The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:\n\n-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy\n\n-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any\n\n-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)\n\n-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality'}], 'classes': [{'categories': [{'measurements': [{'value': '317', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after onset of trial of labor', 'description': 'Mode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Maternal Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trial Of Labour After Caesarean Section', 'description': 'The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:\n\n-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy\n\n-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any\n\n-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)\n\n-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality'}], 'classes': [{'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours after onset of trial of labor', 'description': '• Maternal morbidity:\n\n* Uterine rupture\n* Surgical injuries (during emergency CS)\n* Hemorrhage and blood transfusion\n* Peripartum hysterectomy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Perinatal Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trial Of Labour After Caesarean Section', 'description': 'The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:\n\n-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy\n\n-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any\n\n-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)\n\n-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality'}], 'classes': [{'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours postpartum', 'description': '• Adverse perinatal outcomes:\n\n* Apgar score\n* Neonatal Intensive Care Unit admission\n* Respiratory morbidity, e.g. transient tachypnoea of the newborn\n* Hypoxic ischaemic encephalopathy\n* Birth trauma\n* Mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trial Of Labour After Caesarean Section', 'description': 'The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:\n\n-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy\n\n-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any\n\n-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)\n\n-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This is a retrospective study that was performed at Ain Shams University Maternity Hospital during the 3-year period from January 2013 to December 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Trial Of Labour After Caesarean Section', 'description': 'The following data was gathered (whenever available), tabulated and subjected to the proper statistical analysis:\n\n-Vaginal examination on admission: Cervical status Station of presenting part Membranes status Pelvic adequacy\n\n-Intrapartum management: Progress and duration of labor according to partogram (or admission-delivery time) Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any\n\n-Mode of delivery: Vaginal delivery (spontaneous, assisted, complications) Cesarean section (indication, scar dehiscence)\n\n-Postpartum Data: Postpartum hemorrhage Blood transfusion Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '368', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '4.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '368', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '368', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-16', 'studyFirstSubmitDate': '2017-03-28', 'resultsFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-16', 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Successful Vaginal Birth', 'timeFrame': '24 hours after onset of trial of labor', 'description': 'Mode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Had Maternal Morbidity', 'timeFrame': '48 hours after onset of trial of labor', 'description': '• Maternal morbidity:\n\n* Uterine rupture\n* Surgical injuries (during emergency CS)\n* Hemorrhage and blood transfusion\n* Peripartum hysterectomy'}, {'measure': 'Adverse Perinatal Outcomes', 'timeFrame': '48 hours postpartum', 'description': '• Adverse perinatal outcomes:\n\n* Apgar score\n* Neonatal Intensive Care Unit admission\n* Respiratory morbidity, e.g. transient tachypnoea of the newborn\n* Hypoxic ischaemic encephalopathy\n* Birth trauma\n* Mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Birth After Cesarean']}, 'descriptionModule': {'briefSummary': 'The purpose of the study to evaluate the practice and short term maternal and perinatal outcomes of trial of labor after cesarean section offered to women at Ain Shams University Maternity Hospital (ASUMH) during the 3-year period from January 2013 to December 2015.', 'detailedDescription': 'This is a retrospective study that was performed at Ain Shams University Maternity Hospital.\n\nThe following data will be gathered (whenever available), tabulated and subjected to the proper statistical analysis:\n\nHistory:\n\n* Age\n* Duration of marriage\n* Inter-pregnancy interval\n* Gestational age (by menstrual dates or US)\n* Obstetric history (parity, mode of delivery, assisted vaginal delivery, previous vaginal birth after cesarean section, neonatal outcome)\n* Present and past history of any medical, surgical or obstetric problems; history of infection after previous CS\n\nGeneral examination:\n\n* General condition\n* Vital data\n\nAbdominal examination:\n\n* Fundal level\n* Estimated fetal weight (clinically or by US)\n* Scar tenderness\n\nVaginal examination on admission:\n\n* Cervical status\n* Station of presenting part\n* Membranes status\n* Pelvic adequacy\n\nInvestigations performed:\n\n* Complete Blood Count\n* Ultrasonography\n\nIntrapartum management:\n\n* Progress and duration of labor according to partogram (or admission-delivery time)\n* Intrapartum complications; placental abruption, uterine rupture, hysterectomy, complications during surgical intervention if any\n\nMode of delivery:\n\n* Vaginal delivery (spontaneous, assisted, complications)\n* Cesarean section (indication, scar dehiscence)\n\nPostpartum Data:\n\n* Postpartum hemorrhage\n* Blood transfusion\n* Neonatal outcome; fetal weight, birth trauma, Neonatal Intensive Care Unit admission, mortality'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective study that was performed at Ain Shams University Maternity Hospital Records of hospital admissions during the planned time frame were reviewed. Subjects eligible for conduction of a Trial Of Labor After Cesarean section (TOLAC), were included, while those ineligible for TOLAC were excluded from the study dataset.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women admitted in labour\n* One prior caesarean section\n* Singleton pregnancy\n* Vertex-presenting fetus\n\nExclusion Criteria:\n\n* Prior high-risk uterine scar; uterine rupture, classical CS, hysterotomy or myomectomy\n* Short inter-delivery interval (\\<12 months)\n* Complications in the previous CS (e.g. puerperal sepsis)\n* Obstetric indication for CS (either elective or emergency):\n\n * Placenta praevia\n * Placental abruption\n * Documented evidence of cephalopelvic disproportion\n * Fetal macrosomia (estimated fetal weight \\>4 kg)\n * Fetal anomalies interfering with vaginal delivery e.g. hydrocephalus\n * Fetal distress or non-reassuring Cardiotocography pattern'}, 'identificationModule': {'nctId': 'NCT03098966', 'briefTitle': 'Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Trials of Labor After Previous Cesarean Section in Ain Shams University Maternity Hospital', 'orgStudyIdInfo': {'id': 'TOLAC'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University', 'investigatorFullName': 'Rehab Mohamed Abdelrahman', 'investigatorAffiliation': 'Ain Shams University'}}}}