Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Neurobehavior as Breast-Feeding Predictors

June 12, 2018 updated by: MetroHealth Medical Center

Investigating Potential Determinants of Breast-Feeding Probability: Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Feeding Behavior

Presently, the literature addressing the relationship between epidural analgesia and likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals, administered prior to vaginal delivery of a full-term, healthy neonate, significantly decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum. One proposed mechanism is that analgesics, by decreasing maternal pain during labor, decrease maternal endorphin production and result in the transmission of lower endorphin levels to the neonate during breast-feeding. Lower endorphin levels, in turn, may render the neonate less likely to suckle optimally. Other studies have found that epidural analgesia does not significantly decrease lactation success when used during the vaginal delivery of a full-term, healthy neonate.

Although most studies to date have compared the breast-feeding success of epidural recipients and non-recipients at various points postpartum, they do not specifically note whether deficient feeding behaviors on the part of the infant contribute to failed breast-feeding. The present study uses the LATCH assessment tool to score the infant's ability to latch onto the breast and the presence of audible swallowing, as well as the mother's level of physical comfort with breast feeding, whether she can successfully position the infant for feeding on her own, and whether her nipples are inverted, everted, or flat. Thus, the LATCH assessment enables the separation of multiple factors that may contribute to breast-feeding failure. A multivariate regression analysis will determine how strongly the probability of breast-feeding at hospital discharge correlates with epidural duration, LATCH scores, and beta-endorphin concentrations in colostrum.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth 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

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study is open to all women, aged 18 and over, who are inpatients on the postpartum floor of MetroHealth Medical Center following the vaginal delivery of a single, healthy neonate. A neonate is "healthy" if neither of the following two conditions exists: 1) admission to the neonatal intensive care unit (NICU) following delivery and 2) pathologies, in either mother or baby, that would be reasonably expected to impede normal breast-feeding activity.

Description

Inclusion Criteria:

  • Age 18 or over
  • Vaginal delivery of a single live neonate at MetroHealth Medical Center's Main Campus

Exclusion Criteria:

  • Delivery by Caesarean section
  • Admission to the NICU following delivery
  • Neonatal or maternal pathologies that would obviously impede normal breast-feeding activity

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
Subjects who received epidural analgesia during labor
Non-epidural recipients
Subjects who did not receive epidural analgesia during labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast-Feeding at Discharge
Time Frame: Entire duration of postpartum hospital stay, average 2 days
The primary outcome measure is whether the subject is breast-feeding her infant, either exclusively or with bottle supplementation, at the time of hospital discharge.
Entire duration of postpartum hospital stay, average 2 days

Collaborators and Investigators

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

Sponsor

MetroHealth Medical Center

Investigators

  • Study Director: Charles E Smith, M.D., Dept. of Anesthesiology, MetroHealth Medical Center

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.

General Publications

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 Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (ESTIMATE)

August 31, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Szabo

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.

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