Maternal Anaesthesia and Analgesia Affecting Fetus or NewbornNCT01488149
Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
An observational study of Maternal Anaesthesia and Analgesia Affecting Fetus or Newborn and Breast Feeding, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Anaesthesia and Analgesia Affecting Fetus or Newborn, Breast Feeding, Fentanyl
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Parturients who deliver a single live neonate at UHCMC between February 2012 and June 2012
Who may be able to join
- age 18 or over
Who cannot join
- multiples gestation
- Cesarean section
- neonatal intensive care unit admission
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital Case Medical Center
Cleveland, Ohio
About this study
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
- Keywords
- Fentanyl, Bupivacaine, Nalbuphine
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recipients of intrapartum epidural analgesia | Not described | |
| Non-recipients of intrapartum epidural analgesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal deficiency in latching on to the breast and/or audibly swallowing during feeding
Measured by the standardized LATCH scoring system
Measured: First 5 hours postpartum
Secondary outcomes (1)
Likelihood of breast-feeding at the time of hospital discharge, either exclusively or with bottle supplementation
Measured: Time of discharge from hospital (on average, 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Maternal Anaesthesia and Analgesia Affecting Fetus or NewbornStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley L Szabo, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488149
- Sponsor's protocol ID
- epidural fentanyl
- Status last verified
- Apr 2022
- First submitted
- 5 Dec 2011
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baumgarder DJ, Muehl P, Fischer M, Pribbenow B. Effect of labor epidural anesthesia on breast-feeding of healthy full-term newborns delivered vaginally. J Am Board Fam Pract. 2003 Jan-Feb;16(1):7-13. doi: 10.3122/jabfm.16.1.7.
PubMed 12583645Beilin Y, Bodian CA, Weiser J, Hossain S, Arnold I, Feierman DE, Martin G, Holzman I. Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: a prospective, randomized, double-blind study. Anesthesiology. 2005 Dec;103(6):1211-7. doi: 10.1097/00000542-200512000-00016.
PubMed 16306734Henderson JJ, Dickinson JE, Evans SF, McDonald SJ, Paech MJ. Impact of intrapartum epidural analgesia on breast-feeding duration. Aust N Z J Obstet Gynaecol. 2003 Oct;43(5):372-7. doi: 10.1046/j.0004-8666.2003.t01-1-00117.x.
PubMed 14717315Wiklund I, Norman M, Uvnas-Moberg K, Ransjo-Arvidson AB, Andolf E. Epidural analgesia: breast-feeding success and related factors. Midwifery. 2009 Apr;25(2):e31-8. doi: 10.1016/j.midw.2007.07.005. Epub 2007 Nov 5.
PubMed 17980469Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
PubMed 8176525
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01488149
- Acronym / sponsor ID
- epidural fentanyl
- Conditions
- Maternal Anaesthesia and Analgesia Affecting Fetus or Newborn, Breast Feeding, Fentanyl, Bupivacaine, Nalbuphine
- Keywords
- Fentanyl, Bupivacaine, Nalbuphine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recipients of intrapartum epidural analgesia | – | – |
| Non-recipients of intrapartum epidural analgesia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parturients who deliver a single live neonate at UHCMC between February 2012 and June 2012
Key inclusion criteria (1 listed)
- age 18 or over
Key exclusion criteria (3 listed)
- multiples gestation
- Cesarean section
- neonatal intensive care unit admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Background: PubMed 12583645Baumgarder DJ, Muehl P, Fischer M, Pribbenow B. Effect of labor epidural anesthesia on breast-feeding of healthy full-term newborns delivered vaginally. J Am Board Fam Pract. 2003 Jan-Feb;16(1):7-13. doi: 10.3122/jabfm.16.1.7.
- Background: PubMed 16306734Beilin Y, Bodian CA, Weiser J, Hossain S, Arnold I, Feierman DE, Martin G, Holzman I. Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: a prospective, randomized, double-blind study. Anesthesiology. 2005 Dec;103(6):1211-7. doi: 10.1097/00000542-200512000-00016.
- Background: PubMed 14717315Henderson JJ, Dickinson JE, Evans SF, McDonald SJ, Paech MJ. Impact of intrapartum epidural analgesia on breast-feeding duration. Aust N Z J Obstet Gynaecol. 2003 Oct;43(5):372-7. doi: 10.1046/j.0004-8666.2003.t01-1-00117.x.
- Background: PubMed 17980469Wiklund I, Norman M, Uvnas-Moberg K, Ransjo-Arvidson AB, Andolf E. Epidural analgesia: breast-feeding success and related factors. Midwifery. 2009 Apr;25(2):e31-8. doi: 10.1016/j.midw.2007.07.005. Epub 2007 Nov 5.
- Background: PubMed 8176525Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley L Szabo, M.D. principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Anaesthesia and Analgesia Affecting Fetus or Newborn and Breast Feeding, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal deficiency in latching on to the breast and/or audibly swallowing during feeding (time frame: First 5 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01488149, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.