Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-29 @ 3:54 PM
Study NCT ID:
NCT04826120
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parturients randomized in 2 groups and receiving 2 different interventions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of motor Blockage', 'timeFrame': 'during the epidural analgesia', 'description': 'Bromage scale 1, 2 or 3'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural, Analgesia, Labor, delivery'], 'conditions': ['Epidural; Analgesia']}, 'descriptionModule': {'briefSummary': 'prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.\n\nEpidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).', 'detailedDescription': 'prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.\n\nEpidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).\n\nThe main outcome of this study was: the incidence of motor Blockage. Our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the Visual analogic score (VAS score).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'genderBased': True, 'genderDescription': 'parturients scheduled for vaginal delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term parturients scheduled for vaginal delivery\n\nExclusion Criteria:\n\n* patients in whom cesarean section delivery was indicated during labor'}, 'identificationModule': {'nctId': 'NCT04826120', 'briefTitle': 'Continuous Versus Intermittent Administration of Epidural Analgesia During Labor', 'organization': {'class': 'OTHER', 'fullName': 'Mongi Slim Hospital'}, 'officialTitle': 'Continuous Versus Intermittent Administration of Epidural Analgesia During Labor', 'orgStudyIdInfo': {'id': 'Epidural in Labor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PCEA group', 'description': 'Patients of this group had intermittent epidural analgesia via PCEA associated to systematic 8 ml boluses every 60 min during the second stage of labor.', 'interventionNames': ['Procedure: PCEA Infusion']}, {'type': 'EXPERIMENTAL', 'label': 'CEI Group', 'description': 'Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor.', 'interventionNames': ['Procedure: Continuous epidural infusion']}], 'interventions': [{'name': 'PCEA Infusion', 'type': 'PROCEDURE', 'description': 'Patients of this group Had PCEA during the second stage of labor', 'armGroupLabels': ['PCEA group']}, {'name': 'Continuous epidural infusion', 'type': 'PROCEDURE', 'description': 'Patients of this group Had continuous epidural infusion during the second stage of labor', 'armGroupLabels': ['CEI Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2046', 'city': 'La Marsa', 'state': 'Tunis Governorate', 'country': 'Tunisia', 'facility': 'Mongi Slim University Hospital', 'geoPoint': {'lat': 36.87818, 'lon': 10.32466}}, {'zip': '2046', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Mongi Slim Hospital', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mongi Slim Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, head of department of anesthesia and critical care', 'investigatorFullName': 'Mhamed Sami Mebazaa', 'investigatorAffiliation': 'Mongi Slim Hospital'}}}}