Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-18 @ 10:03 AM
Study NCT ID:
NCT01648595
Status:
TERMINATED
Last Update Posted:
2012-07-24
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fentanyl on Pain Severity and Duration of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], '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'}]}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 70}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2006-09'}, 'lastUpdateSubmitDate': '2012-07-23', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'decrease pain and duration of the active phase considerably.', 'timeFrame': 'up to 8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fentanyl', 'analgesia', 'duration of the active phase', 'pain severity'], 'conditions': ['Decrease Labor Pain']}, 'descriptionModule': {'briefSummary': 'Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain of delivery. It is necessary to be known effect of these drugs on the mother and fetus during labor adverse. Therefore, the purpose of this study was determination of effect of Fentanyl intravenously on pain severity during the active phase of labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '21 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* multiparas pregnant women (gravid 2-7),\n* term singleton pregnancy,\n* cephalic presentation,\n* low risk pregnancy with no history of drug tolerance (addiction),\n* medical and mental diseases.\n\nExclusion Criteria:\n\n* Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).'}, 'identificationModule': {'nctId': 'NCT01648595', 'briefTitle': 'Effect of Fentanyl on Pain Severity and Duration of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Principal Investigator', 'orgStudyIdInfo': {'id': 'Effect of Fentanyl'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl', 'description': 'In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour. In control group was not intervention.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'NO_INTERVENTION', 'label': 'Without Fentanyl', 'description': 'The control group did not receive Fentanyl.'}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour after being diluted in 4 cc normal saline', 'armGroupLabels': ['Fentanyl']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Faculty of Midwifery', 'investigatorFullName': 'Nahid Jahani Shoorab', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}