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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by MetroHealth Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01191970
First received: August 27, 2010
Last updated: December 17, 2010
Last verified: September 2010
  Purpose

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.


Condition
Breastfeeding
Lactation
Analgesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Potential Determinants of Breast-Feeding Probability: Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Feeding Behavior

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • Breast-Feeding at Discharge [ Time Frame: Entire duration of postpartum hospital stay, average 2 days ] [ Designated as safety issue: No ]
    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.


Biospecimen Description:

Colostrum samples collected 2x/d for duration of postpartum hospital stay, which is, on average, 2d.


Estimated Enrollment: 500
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epidural recipients
Subjects who received epidural analgesia during labor
Non-epidural recipients
Subjects who did not receive epidural analgesia during labor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191970

Contacts
Contact: Charles E Smith, M.D. als124@case.edu

Locations
United States, Ohio
MetroHealth Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44109
Sub-Investigator: Charles E Smith, M.D.         
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Study Director: Charles E Smith, M.D. Dept. of Anesthesiology, MetroHealth Medical Center
  More Information

Publications:
Responsible Party: Charles Smith, M.D., MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01191970     History of Changes
Other Study ID Numbers: 1-Szabo
Study First Received: August 27, 2010
Last Updated: December 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
epidural
beta-endorphins
breast-feeding
colostrum
feeding

Additional relevant MeSH terms:
Beta-Endorphin
Endorphins
Adrenocorticotropic Hormone
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014