Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01260051
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2010-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast-Feeding at Hospital Discharge', 'timeFrame': 'Baseline', 'description': 'This outcome variable is binary. If a woman is breast-feeding with bottle supplementation at the time of hospital discharge, then she is recorded as "Yes."'}], 'secondaryOutcomes': [{'measure': 'L&A Components of LATCH Score', 'timeFrame': 'Baseline', 'description': 'The L component of the score measures neonatal ability to latch at the breast and the A component measures the presence of audible swallows, which are variables that reflect neonatal neurobehavioral capacity with respect to feeding.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia, Epidural', 'Breast Feeding']}, 'referencesModule': {'references': [{'pmid': '17062784', 'type': 'BACKGROUND', 'citation': 'Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006 Nov;22(4):391-7. doi: 10.1177/0890334406293161.'}, {'pmid': '16306734', 'type': 'BACKGROUND', 'citation': 'Beilin Y, Bodian CA, Weiser J, Hossain S, Arnold I, Feierman DE, Martin G, Holzman I. Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: a prospective, randomized, double-blind study. Anesthesiology. 2005 Dec;103(6):1211-7. doi: 10.1097/00000542-200512000-00016.'}, {'pmid': '17980469', 'type': 'BACKGROUND', 'citation': 'Wiklund I, Norman M, Uvnas-Moberg K, Ransjo-Arvidson AB, Andolf E. Epidural analgesia: breast-feeding success and related factors. Midwifery. 2009 Apr;25(2):e31-8. doi: 10.1016/j.midw.2007.07.005. Epub 2007 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'Currently, no clear consensus exists regarding the effect of epidural anesthesia upon breast-feeding. In theory, epidurals may increase breast-feeding failure via inadequate maternal milk production, deficiencies in neonatal neurobehavior, or both, but most studies have failed to separate these potential mechanisms. The present study examines whether epidural duration correlates with 1) likelihood of breast-feeding at hospital discharge and 2) neonatal neurobehavioral deficits in feeding, as measured by the L\\&A components of the standardized, validated LATCH scoring system.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parturients who delivered at UHCMC between August 2009 and January 2010', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaginal delivery\n* Delivery of a single live neonate\n\nExclusion Criteria:\n\n* NICU admission following delivery\n* Pitocin augmentation'}, 'identificationModule': {'nctId': 'NCT01260051', 'briefTitle': 'Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes', 'orgStudyIdInfo': {'id': 'uhcmc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidural Recipients'}, {'label': 'Non-Epidural Recipients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Ashley L Szabo, MD Candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}