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

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260051
• Other study ID #: uhcmc
• Status: Completed
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: April 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vaginal delivery

• Delivery of a single live neonate

Exclusion Criteria:

• NICU admission following delivery

• Pitocin augmentation

Related Conditions & MeSH terms

• Anesthesia, Epidural
• Breast Feeding

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Wiklund I, Norman M, Uvnäs-Moberg K, Ransjö-Arvidson AB, Andolf E. Epidural analgesia: breast-feeding success and related factors. Midwifery. 2009 Apr;25(2):e31-8. Epub 2007 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	Baseline
Secondary	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.	Baseline