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

NCT01191970 | Withdrawn

• 1 other identifier: 1-Szabo
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Lactation; Analgesia

Keywords

epidural; beta-endorphins; breast-feeding; colostrum; feeding

Outcome Measures

Primary Outcomes (1)

• Breast-Feeding at Discharge

  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

Study Arms (2)

Epidural recipients

Subjects who received epidural analgesia during labor

Non-epidural recipients

Subjects who did not receive epidural analgesia during labor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (8)

• Baumgarder DJ, Muehl P, Fischer M, Pribbenow B. Effect of labor epidural anesthesia on breast-feeding of healthy full-term newborns delivered vaginally. J Am Board Fam Pract. 2003 Jan-Feb;16(1):7-13. doi: 10.3122/jabfm.16.1.7.

  PMID: 12583645 BACKGROUND

• 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: 16306734 BACKGROUND

• Chang ZM, Heaman MI. Epidural analgesia during labor and delivery: effects on the initiation and continuation of effective breastfeeding. J Hum Lact. 2005 Aug;21(3):305-14; quiz 315-9, 326. doi: 10.1177/0890334405277604.

  PMID: 16113019 BACKGROUND

• Henderson JJ, Dickinson JE, Evans SF, McDonald SJ, Paech MJ. Impact of intrapartum epidural analgesia on breast-feeding duration. Aust N Z J Obstet Gynaecol. 2003 Oct;43(5):372-7. doi: 10.1046/j.0004-8666.2003.t01-1-00117.x.

  PMID: 14717315 BACKGROUND

• Zanardo V, Nicolussi S, Carlo G, Marzari F, Faggian D, Favaro F, Plebani M. Beta endorphin concentrations in human milk. J Pediatr Gastroenterol Nutr. 2001 Aug;33(2):160-4. doi: 10.1097/00005176-200108000-00012.

  PMID: 11568517 BACKGROUND

• 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: 17062784 BACKGROUND

• Volmanen P, Valanne J, Alahuhta S. Breast-feeding problems after epidural analgesia for labour: a retrospective cohort study of pain, obstetrical procedures and breast-feeding practices. Int J Obstet Anesth. 2004 Jan;13(1):25-9. doi: 10.1016/S0959-289X(03)00104-3.

  PMID: 15321436 BACKGROUND

• Gray L, Miller LW, Philipp BL, Blass EM. Breastfeeding is analgesic in healthy newborns. Pediatrics. 2002 Apr;109(4):590-3. doi: 10.1542/peds.109.4.590.

  PMID: 11927701 BACKGROUND

Biospecimen

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

MeSH Terms

Conditions

Breast Feeding; Agnosia

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles E Smith, M.D.

  Dept. of Anesthesiology, MetroHealth Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 31, 2010
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

US (1)