Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT04290702
Status:
UNKNOWN
Last Update Posted:
2020-03-05
First Post:
2020-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 groups with different regional analgesic technique'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2020-01-19', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analgesic consumption', 'timeFrame': 'during the procedure/delivery', 'description': 'the amount of local anesthetic and opioid that required during labor'}], 'secondaryOutcomes': [{'measure': 'pain intensity on a numerical rating scale (minimum=0, maximum=10)', 'timeFrame': 'during the procedure/delivery', 'description': 'pain intensity'}, {'measure': 'duration of labor', 'timeFrame': 'until delivery', 'description': 'duration of first stage'}, {'measure': 'satisfaction on a numerical rating scale (minimum=0, maximum=10)', 'timeFrame': 'during the procedure/delivery', 'description': 'satisfaction of parturients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain', 'Analgesia']}, 'descriptionModule': {'briefSummary': 'The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parturients requiring regional labor analgesia\n* dilation less than 5cm\n\nExclusion Criteria:\n\n* contraindication for regional technique\n* refuse to participate\n* language barriers\n* obesity\n* no pain'}, 'identificationModule': {'nctId': 'NCT04290702', 'briefTitle': 'Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study', 'orgStudyIdInfo': {'id': '155/19-12-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'epidural', 'interventionNames': ['Procedure: regional analgesia for labor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'combined', 'interventionNames': ['Procedure: regional analgesia for labor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dural puncture epidural', 'interventionNames': ['Procedure: regional analgesia for labor']}], 'interventions': [{'name': 'regional analgesia for labor', 'type': 'PROCEDURE', 'description': 'three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia', 'armGroupLabels': ['combined', 'dural puncture epidural', 'epidural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Chryssoula V Staikou, MD', 'role': 'CONTACT', 'email': 'c_staikou@yahoo.gr', 'phone': '+210 7286172'}, {'name': 'Chryssoula V Staikou, MD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aretaieio Hospital, University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Chryssoula V Staikou, Assoc Prof', 'role': 'CONTACT'}], 'facility': 'Aretaieio Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Chyrssoula Staikou, Assoc Prof', 'role': 'CONTACT', 'email': 'c_staikou@yahoo.gr', 'phone': '00302107780172'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Staikou Chryssoula', 'investigatorAffiliation': 'University of Athens'}}}}