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

December 14, 2010
December 16, 2010
March 2010
July 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01260051 on ClinicalTrials.gov Archive Site
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."
Same as current
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Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes
Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Parturients who delivered at UHCMC between August 2009 and January 2010

  • Anesthesia, Epidural
  • Breast Feeding
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  • Epidural Recipients
  • Non-Epidural Recipients
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
November 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Vaginal delivery
  • Delivery of a single live neonate

Exclusion Criteria:

  • NICU admission following delivery
  • Pitocin augmentation
Female
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260051
uhcmc
No
Ashley Szabo, M.D. Candidate, Case Western Reserve University School of Medicine
University Hospital Case Medical Center
Not Provided
Principal Investigator: Ashley L Szabo, MD Candidate Case Western Reserve University School of Medicine
University Hospital Case Medical Center
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP