Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
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|ClinicalTrials.gov 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
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|
|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|
|Recipients of intrapartum epidural analgesia|
|Non-recipients of intrapartum epidural analgesia|
- 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
- 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) ]
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 ClinicalTrials.gov identifier (NCT number): NCT01488149
|Contact: ASHLEY SZABO, M.D.||email@example.com|
|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 Hospitals Cleveland Medical Center|