Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT03980951
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2019-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuroaxial Labour Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007268', 'term': 'Injections, Epidural'}], 'ancestors': [{'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial assignment placed in sealed envelopes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'epidural Local anesthetic consumption', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Maternal hypotension', 'timeFrame': '1 year', 'description': 'maternal mean arterial blood pressure less than 50 mmhg'}, {'measure': 'incidence of fetal bradycardia', 'timeFrame': '1 year', 'description': 'a fetal heart rate of less than 100 beats per minute'}, {'measure': 'incidence of maternal pruritus', 'timeFrame': '1 year', 'description': 'Participants will be assessed for pruritus every hour, by grading the severity on a scale ranging from 0-3; 0 = none, 1 = mild, 2= moderate and 3 = severe'}, {'measure': 'labour pain scores', 'timeFrame': '1 year', 'description': 'Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Analgesia']}, 'referencesModule': {'references': [{'pmid': '34349372', 'type': 'DERIVED', 'citation': 'Bakhet WZ. A randomized comparison of epidural, dural puncture epidural, and combined spinal-epidural without intrathecal opioids for labor analgesia. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):231-236. doi: 10.4103/joacp.JOACP_347_19. Epub 2021 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural\n\nThe secondary objective of this study is to compare the and fetomaternal outcomes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'females requesting labor analgesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Nulliparous parturient\n2. Singleton, vertex gestation at term (37-42 weeks)\n3. Less than 5 cm dilation\n4. request an epidural technique for labor analgesia\n\nExclusion Criteria:\n\n1. Hypersensitivity to local the study drugs\n2. Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)\n3. Any contraindication to the administration of an epidural technique\n4. Risk factor for cesarean delivery.\n5. fetal anomalies'}, 'identificationModule': {'nctId': 'NCT03980951', 'briefTitle': 'Neuroaxial Labour Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.', 'orgStudyIdInfo': {'id': '2019 WB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'combined spinal epidural group', 'description': 'Bupivacaine 2.5 mg', 'interventionNames': ['Procedure: Combined Spinal Epidural without intrathecal opioids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dura puncture epidural group', 'description': 'Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min', 'interventionNames': ['Procedure: Dural Puncture Epidural Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'epidural', 'description': 'Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min', 'interventionNames': ['Procedure: epidural']}], 'interventions': [{'name': 'Dural Puncture Epidural Technique', 'type': 'PROCEDURE', 'description': 'three labor analgesia techniques', 'armGroupLabels': ['dura puncture epidural group']}, {'name': 'Combined Spinal Epidural without intrathecal opioids', 'type': 'PROCEDURE', 'description': 'three labor analgesia techniques', 'armGroupLabels': ['combined spinal epidural group']}, {'name': 'epidural', 'type': 'PROCEDURE', 'description': 'three labor analgesia techniques', 'armGroupLabels': ['epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'state': 'Abbasyia', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '002', 'city': 'Kuwait City', 'state': 'Abbasyia', 'country': 'Kuwait', 'facility': 'Elite Hospital', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wahba bakhet', 'class': 'OTHER'}, 'collaborators': [{'name': 'elite medical hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Wahba bakhet', 'investigatorAffiliation': 'Ain Shams University'}}}}