Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Maternal Anaesthesia and Analgesia Affecting Fetus or Newborn; Breast Feeding; Fentanyl; Bupivacaine; Nalbuphine
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital Case Medical Center Official(s) and/or principal investigator(s): Ashley L Szabo, M.D., Principal Investigator, Affiliation: University Hospital Case Medical Center
Overall contact: ASHLEY SZABO, M.D., Email: ashleyszabo@alumni.nd.edu
Summary
Intrapartum epidural analgesia has been associated with adverse breastfeeding outcomes. One
potential mechanism involves transfer of epidural fentanyl across the placenta and neonatal
blood-brain barrier, where it can subsequently attenuate neonatal exhibition of feeding
behaviors, such as latching and swallowing, during the immediate postpartum period. Vigorous
feeding behavior during the first days of life is a significant predictor of long-term
breastfeeding success at 3 and 6 months. In a randomized, controlled, double-blinded study,
neonatal Neurologic and Adaptive Capacity Scores (NACS) were significantly lower when
mothers received >150 mcg epidural fentanyl versus bupivacaine-only analgesia, and mean
umbilical cord fentanyl concentration was significantly higher in the >150 mcg versus <150
mcg group.
The investigators hypothesize that epidural fentanyl-bupivacaine analgesia is significantly
associated with decreased breastfeeding rates at hospital discharge and with neonatal
deficits in latching onto the breast and swallowing during the first three hours of life,
and that a significant dose-response relationship exists with respect to total micrograms
fentanyl infused.
The investigators will perform a prospective cohort study of all parturients age 18+ at
UHCMC over a three-month period, excluding those with multiples gestation, Cesarean section,
or neonatal intensive care unit admission. From patient charts, the investigators will
record the following variables: number of neonates delivered; type of delivery (spontaneous
vaginal / operative vaginal / Cesarean section); whether the neonate was admitted to the
intensive care unit; the mother's age, height, weight, gravity, parity, intention to
breast-feed at the time of hospital admission, number of children previously breast-fed, and
ethnicity; gestational age at the time of delivery; administration of oxytocin for labor
augmentation and in what quantity; duration of active labor; antibiotic administration;
neonatal APGAR scores at 1 and 5 minutes postpartum; and whether opioids or antibiotics were
administered before and/or after the delivery and at what exact time. We will also record
whether each patient received an epidural during labor and, if so, the duration of this
epidural infusion and the total micrograms fentanyl delivered; neonatal feeding behavior as
quantified by the LATCH scores assigned to each breast-feeding interaction that occurs on
the postpartum care floor; whether the mother is breast-feeding her baby at the time of
discharge from the hospital, and if not, then her primary reason for not doing so (as
communicated during the standard postpartum lactation consultation); and how long mother and
baby stayed in the hospital post-delivery.
Clinical Details
Official title: Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Neonatal deficiency in latching on to the breast and/or audibly swallowing during feeding
Secondary outcome: Likelihood of breast-feeding at the time of hospital discharge, either exclusively or with bottle supplementation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- age 18 or over
Exclusion Criteria:
- multiples gestation
- Cesarean section
- neonatal intensive care unit admission
Locations and Contacts
ASHLEY SZABO, M.D., Email: ashleyszabo@alumni.nd.edu
University Hospital Case Medical Center, Cleveland, Ohio, United States; Recruiting Ashley Szabo, M.D., Principal Investigator Jerrad Businger, D.O., Sub-Investigator Evan Goodman, M.D., Sub-Investigator
Additional Information
Related publications: 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. 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. 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. Wiklund I, Norman M, Uvnäs-Moberg K, Ransjö-Arvidson AB, Andolf E. Epidural analgesia: breast-feeding success and related factors. Midwifery. 2009 Apr;25(2):e31-8. Epub 2007 Nov 5. Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32.
Starting date: February 2012
Last updated: May 29, 2012
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