Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-25 @ 6:08 PM
Study NCT ID:
NCT04012450
Status:
UNKNOWN
Last Update Posted:
2019-07-09
First Post:
2019-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Combined Spinal-epidural Anesthetics During Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000767', 'term': 'Anesthesia, Epidural'}], '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': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-05', 'studyFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2019-07-05', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine artery flow', 'timeFrame': 'Up to 48 hours from onset of anesthesia', 'description': 'Changes in uterine artery flow before and after regional anesthesia'}, {'measure': 'Umbilical artery flow', 'timeFrame': 'Up to 48 hours from onset of anesthesia', 'description': 'Changes in umbilical artery flow before and after regional anesthesia'}, {'measure': 'Middle cerebral artery flow', 'timeFrame': 'Up to 48 hours from onset of anesthesia', 'description': 'Changes in middle cerebral artery flow before and after regional anesthesia'}], 'secondaryOutcomes': [{'measure': 'Fetal heart rate abnormalities', 'timeFrame': 'Up to 48 hours from onset of anesthesia', 'description': 'Fetal heart rate deceleration'}, {'measure': 'Fetal bradycardia within 1 hour', 'timeFrame': 'Up to one hour from onset of anesthesia', 'description': 'Fetal bradycardia'}, {'measure': 'Mode of delivery', 'timeFrame': 'Up to delivery', 'description': 'Mode of delivery - vaginal/instrumental/cesarean section'}, {'measure': 'Meconial amniotic fluid', 'timeFrame': 'Up to delivery', 'description': 'Meconial amniotic fluid'}, {'measure': 'Umbilical artery blood acidity level (PH)', 'timeFrame': 'Immediate after delivery', 'description': 'Umbilical artery blood PH'}, {'measure': 'Apgar at 1 and 5 minutes', 'timeFrame': 'Up to 5 minutes from delivery', 'description': 'Apgar at 1 and 5 minutes'}, {'measure': 'Admission to Neonatal Intensive Care Unit (NICU)', 'timeFrame': 'Up to 72 hours from delivery', 'description': 'Admission to NICU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Women who fulfil the inclusion criteria and who intended to regional anesthesia will be randomized into the epidural anesthesia arm or to the spinal-epidural anesthesia arm. Sonographic evaluation of the flow in the uterine artery, umbilical artery, and middle cerebral artery will be documented to each patient prior and following the regional anesthesia.', 'detailedDescription': "Patients will receive information regarding the available anesthesia during labor that are available in the delivery room including regional and systemic.\n\nAfter receiving the patient informed consent for regional anesthesia (epidural or spinal-epidural), patients will be offered to participate in our study.\n\nAfter receiving the patients' informed consent for participating in the study, patients will be randomized to either the epidural anesthesia group or to the spinal-epidural anesthesia group.\n\nA doppler ultrasound will be performed on each patient prior to and following the regional anesthesia, the flow in the uterine artery, umbilical artery, and the middle cerebral artery of the fetus will be recorded.\n\nDemographic and obstetrical information will be collected from the patients' electronic files."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nGestational age of 37 and above Singleton Vertex presentation Desired regional anesthesia\n\nExclusion criteria:\n\nContraindication to regional anesthesia Placental abnormalities (placenta previa, placenta accreta, placental separation) Pregnancy following fetal reduction or intrauterine fetal death (IUFD) Fetal malformations Intrauterine growth retardation (IUGR) Suspected chorioamnionitis (including body temperature above 38.5 degrees Celsius)'}, 'identificationModule': {'nctId': 'NCT04012450', 'briefTitle': 'The Effects of Combined Spinal-epidural Anesthetics During Labor', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Effects of Combined Spinal-epidural Anesthetics During Labor', 'orgStudyIdInfo': {'id': '0500-15-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural Anesthesia', 'description': 'Women in labor receiving epidural anesthesia', 'interventionNames': ['Procedure: Epidural anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal-epidural', 'description': 'Women in labor receiving spinal-epidural anesthesia', 'interventionNames': ['Procedure: spina-epidural anesthesia']}], 'interventions': [{'name': 'Epidural anesthesia', 'type': 'PROCEDURE', 'description': 'Performing an epidural anesthesia', 'armGroupLabels': ['Epidural Anesthesia']}, {'name': 'spina-epidural anesthesia', 'type': 'PROCEDURE', 'description': 'Performing a spina-epidural anesthesia', 'armGroupLabels': ['Spinal-epidural']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Saar Aharoni, MD', 'role': 'CONTACT', 'email': 'saaraharoni@gmail.com', 'phone': '+ 972 523395351'}], 'overallOfficials': [{'name': 'Saar Aharoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Heath-Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SAAR AHARONI MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}