Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Neurobehavior as Breast-Feeding Predictors
|ClinicalTrials.gov Identifier: NCT01191970|
Recruitment Status : Unknown
Verified September 2010 by MetroHealth Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 31, 2010
Last Update Posted : December 20, 2010
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 or disease|
|Breastfeeding Lactation Analgesia|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Investigating Potential Determinants of Breast-Feeding Probability: Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Feeding Behavior|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||March 2012|
Subjects who received epidural analgesia during labor
Subjects who did not receive epidural analgesia during labor
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191970
|Contact: Charles E Smith, M.D.||email@example.com|
|United States, Ohio|
|MetroHealth Medical Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44109|
|Sub-Investigator: Charles E Smith, M.D.|
|Study Director:||Charles E Smith, M.D.||Dept. of Anesthesiology, MetroHealth Medical Center|