Text Size

Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes

This study has been completed.
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01260051
First received: December 14, 2010
Last updated: December 16, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition
Anesthesia, Epidural
Breast Feeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • L&A Components of LATCH Score [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Breast-Feeding at Hospital Discharge [ Designated as safety issue: No ]
    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."


Enrollment: 310
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epidural Recipients
Non-Epidural Recipients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population

Parturients who delivered at UHCMC between August 2009 and January 2010

Criteria

Inclusion Criteria:

  • Vaginal delivery
  • Delivery of a single live neonate

Exclusion Criteria:

  • NICU admission following delivery
  • Pitocin augmentation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260051

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Ashley L Szabo, MD Candidate Case Western Reserve University School of Medicine
  More Information

Publications:

Responsible Party: Ashley Szabo, M.D. Candidate, Case Western Reserve University School of Medicine
ClinicalTrials.gov Identifier: NCT01260051     History of Changes
Other Study ID Numbers: uhcmc
Study First Received: December 14, 2010
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 21, 2013