Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
NCT01488149 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2022-04-18
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.
Conditions
- Maternal Anaesthesia and Analgesia Affecting Fetus or Newborn
- Breast Feeding
- Fentanyl
- Bupivacaine
- Nalbuphine
Sponsors & Collaborators
-
University Hospitals Cleveland Medical Center
lead OTHER
Principal Investigators
-
Ashley L Szabo, M.D. · University Hospitals Cleveland Medical Center
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2012-06-30
- Completion
- 2012-06-30
Countries
- United States
Study Locations
More Related Trials
-
Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates
NCT00286143 ·Status: COMPLETED ·Phase: PHASE3
-
The Influence of Breastfeeding on Cortical Activity During Procedures
NCT03272594 ·Status: COMPLETED ·Phase: PHASE3
-
Endogenous Pain Facilitation and Inhibition in Postpartum Women
NCT01843517 ·Status: COMPLETED
-
Effects of Breast Feeding on Post-Cesarean and Post-Vaginal Delivery Pain
NCT01417260 ·Status: COMPLETED
-
Postpartum Pain Experience and Attitudes About Opioid Prescribing
NCT05202795 ·Status: COMPLETED
-
Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes
NCT01891201 ·Status: COMPLETED
-
Prevention of the Procedural Pain in the Newborn
NCT02109263 ·Status: COMPLETED ·Phase: NA
-
Interest of Using the Sevoflurane in the Prevention of Newborns Pain
NCT00420693 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
NCT03389789 ·Status: COMPLETED ·Phase: NA
-
Postoperative Pain Control & Relief in Neonates
NCT03677830 ·Status: TERMINATED ·Phase: PHASE4
-
Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
NCT00482560 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect of Neuraxial Morphine (Duramorph) on Pain Control
NCT03926559 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
NCT00908401 ·Status: UNKNOWN ·Phase: PHASE3
-
Breast Feeding Analgesia in Preterm Infants
NCT00175409 ·Status: COMPLETED ·Phase: PHASE1
-
Codeine in Mechanically Ventilated Neonates
NCT01322204 ·Status: COMPLETED ·Phase: PHASE1
-
Neurodegeneration in Newborns After Anesthetics
NCT03064607 ·Status: COMPLETED
-
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy
NCT00200590 ·Status: TERMINATED ·Phase: NA
-
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
NCT02851303 ·Status: COMPLETED ·Phase: PHASE4
-
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
NCT04149509 ·Status: ACTIVE_NOT_RECRUITING
-
Effects of Three Different Methods in Reducing Pain During Heel Blood Collection
NCT06741670 ·Status: COMPLETED ·Phase: NA
-
Nonpharmacological Pain Management in Neonates
NCT06155825 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention
NCT02125201 ·Status: COMPLETED ·Phase: PHASE4
-
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
NCT04772222 ·Status: COMPLETED ·Phase: PHASE2
-
Pain Managment in Preterm Neonates
NCT07148882 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Maternal Involvement in Pain Management in NICU
NCT04883944 ·Status: COMPLETED ·Phase: NA