NCT01260051

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

December 14, 2010

Last Update Submit

April 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • L&A Components of LATCH Score

    Baseline

Study Arms (2)

Epidural Recipients

Non-Epidural Recipients

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parturients who delivered at UHCMC between August 2009 and January 2010

You may qualify if:

  • Vaginal delivery
  • Delivery of a single live neonate

You may not qualify if:

  • NICU admission following delivery
  • Pitocin augmentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

  • 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: 17062784BACKGROUND
  • 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: 16306734BACKGROUND
  • 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.

    PMID: 17980469BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Ashley L Szabo, MD Candidate

    Case Western Reserve University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 15, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2010

Study Completion

November 1, 2010

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations