Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University Hospital Case Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ashley Szabo, M.D., University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01488149
First received: December 5, 2011
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition
Maternal Anaesthesia and Analgesia Affecting Fetus or Newborn
Breast Feeding
Fentanyl
Bupivacaine
Nalbuphine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Neonatal deficiency in latching on to the breast and/or audibly swallowing during feeding [ Time Frame: First 5 hours postpartum ] [ Designated as safety issue: No ]
    Measured by the standardized LATCH scoring system


Secondary Outcome Measures:
  • Likelihood of breast-feeding at the time of hospital discharge, either exclusively or with bottle supplementation [ Time Frame: Time of discharge from hospital (on average, 2 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Recipients of intrapartum epidural analgesia
Non-recipients of intrapartum epidural analgesia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parturients who deliver a single live neonate at UHCMC between February 2012 and June 2012

Criteria

Inclusion Criteria:

  • age 18 or over

Exclusion Criteria:

  • multiples gestation
  • Cesarean section
  • neonatal intensive care unit admission
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01488149

Contacts
Contact: ASHLEY SZABO, M.D. ashleyszabo@alumni.nd.edu
Contact: JERRAD BUSINGER, D.O.

Locations
United States, Ohio
University Hospital Case Medical Center Recruiting
Cleveland, Ohio, United States
Principal Investigator: Ashley Szabo, M.D.         
Sub-Investigator: Jerrad Businger, D.O.         
Sub-Investigator: Evan Goodman, M.D.         
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Ashley L Szabo, M.D. University Hospital Case Medical Center
  More Information

Publications:
Responsible Party: Ashley Szabo, M.D., Principal Investigator, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01488149     History of Changes
Other Study ID Numbers: epidural fentanyl
Study First Received: December 5, 2011
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Fentanyl
Bupivacaine
Nalbuphine

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 01, 2014