Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-09 @ 2:28 PM
Study NCT ID:
NCT03640702
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2018-08-14', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of primary CS.', 'timeFrame': 'Between 2011 and 2017.', 'description': 'The rate of primary CS in percentage of the total participants.'}], 'secondaryOutcomes': [{'measure': 'The rate of operative vaginal delivery.', 'timeFrame': 'Between 2011 and 2017.', 'description': 'The rate of operative vaginal delivery in percentage of the total participants.'}, {'measure': 'Post-partum hemorrhage.', 'timeFrame': 'Between 2011 and 2017.', 'description': 'Post-partum hemorrhage as estimated in liters.'}, {'measure': 'The need for blood transfusion.', 'timeFrame': 'Between 2011 and 2017.', 'description': 'Number and type of blood products required post-partum and calculation of the number of patients that required blood products out of the total number of participants in percentage.'}, {'measure': 'Third-and fourth-degree laceration rate.', 'timeFrame': 'Between 2011 and 2017.', 'description': 'Third-and fourth-degree laceration rate of the total number of participants.'}, {'measure': 'Chorioamnionitis rate.', 'timeFrame': 'Between 2011 and 2017.', 'description': 'Chorioamnionitis rate in percentage of the total participants.'}, {'measure': 'Admission to the NICU.', 'timeFrame': 'Between 2011 and 2017.', 'description': 'Admission to the NICU in percentage of the total participants.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': "The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.\n\nThe study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.", 'detailedDescription': "The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.\n\nThe study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.\n\nThe rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women in labor', 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Singleton deliveries at or beyond 37 weeks' gestation.\n\nExclusion Criteria:\n\n1. Non-vertex presentation.\n2. Trial of labor after CS.\n3. High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).\n4. Known fetal anomalies and intrauterine fetal demise."}, 'identificationModule': {'nctId': 'NCT03640702', 'briefTitle': 'The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes', 'orgStudyIdInfo': {'id': '0258-17-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prolonged second stage of labor', 'description': 'Women with prolonged second stage of labor as specified before.', 'interventionNames': ['Other: Protocol change']}], 'interventions': [{'name': 'Protocol change', 'type': 'OTHER', 'description': 'To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes', 'armGroupLabels': ['Prolonged second stage of labor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Kamel Mattar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kamel Mattar MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}