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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01260051
First Posted: December 15, 2010
Last Update Posted: December 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospitals Cleveland Medical Center
  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:


Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • L&A Components of LATCH Score
    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
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260051


Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland 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
First Submitted: December 14, 2010
First Posted: December 15, 2010
Last Update Posted: December 17, 2010
Last Verified: February 2010

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