Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 4:05 PM
Study NCT ID:
NCT00296751
Status:
COMPLETED
Last Update Posted:
2010-07-01
First Post:
2006-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidural Analgesia Versus IV Meperidine for Labor Pain Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-30', 'studyFirstSubmitDate': '2006-02-24', 'studyFirstSubmitQcDate': '2006-02-24', 'lastUpdatePostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.'}]}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': '60 female that care for pain control during second stage of delivery, will choose between epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the second stage for 10 minutes. 30 minutes after administration of either pain relief, a second recording of maternal ECG will take place for 10 minutes.', 'detailedDescription': 'Population 60 female during second stage of delivery\n\n* Inclusion criteria : all parturients requiring pain relief will choose between systemic or epidural analgesia.\n* Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular autonomic system.\n* Method: A 10 minute recording of a 3 lead ECG will be performed during the second stage of the delivery (3-7 CM opening).\n\nthe parturient will be lying on her left side for that period.\n\n* 30 minutes after administration of either epidural or systemic Meperidine for pain relief, a second recording of maternal ECG will take place for 10 minutes.\n* estimated duration of the procedure about one hour per woman.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: all parturients requiring pain relief will choose between systemic or epidural analgesia.\n\nExclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular or autonomic system.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00296751', 'briefTitle': 'Epidural Analgesia Versus IV Meperidine for Labor Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.', 'orgStudyIdInfo': {'id': 'epiduralCTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ECG recording', 'type': 'PROCEDURE'}, {'name': 'Epidural catheter insertion', 'type': 'PROCEDURE'}, {'name': 'Intravenous meperidine injection', 'type': 'DRUG'}, {'name': 'Epidural Bupivacaine and fentanyl injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam - health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Amir Weissman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Olga Torchov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}}}}