Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
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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 |
- 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
- 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 |
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
Contacts and Locations| Contact: ASHLEY SZABO, M.D. | ashleyszabo@alumni.nd.edu | |
| Contact: JERRAD BUSINGER, D.O. |
| 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. | |
| 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 Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 23, 2013