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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Parturients who delivered at UHCMC between August 2009 and January 2010

Description

Inclusion Criteria:

  • Vaginal delivery
  • Delivery of a single live neonate

Exclusion Criteria:

  • NICU admission following delivery
  • Pitocin augmentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Epidural Recipients
Non-Epidural Recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast-Feeding at Hospital Discharge
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
L&A Components of LATCH Score
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ashley L Szabo, MD Candidate, Case Western Reserve University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • uhcmc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Feeding

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