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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01488149
Recruitment Status : Unknown
Verified May 2012 by Ashley Szabo, M.D., University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
First Posted : December 8, 2011
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):
Ashley Szabo, M.D., University Hospitals Cleveland Medical Center

Brief 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.

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

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
Study Start Date : February 2012
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Recipients of intrapartum epidural analgesia
Non-recipients of intrapartum epidural analgesia

Primary Outcome Measures :
  1. Neonatal deficiency in latching on to the breast and/or audibly swallowing during feeding [ Time Frame: First 5 hours postpartum ]
    Measured by the standardized LATCH scoring system

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Inclusion Criteria:

  • age 18 or over

Exclusion Criteria:

  • multiples gestation
  • Cesarean section
  • neonatal intensive care unit admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01488149


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 Hospitals Cleveland Medical Center
Principal Investigator: Ashley L Szabo, M.D. University Hospitals Cleveland Medical Center

Responsible Party: Ashley Szabo, M.D., Principal Investigator, University Hospitals Cleveland Medical Center Identifier: NCT01488149     History of Changes
Other Study ID Numbers: epidural fentanyl
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Ashley Szabo, M.D., University Hospitals Cleveland Medical Center:

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