BreastfeedingNCT01191970
Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Neurobehavior as Breast-Feeding Predictors
An observational study of Breastfeeding and Lactation, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Presently, the literature addressing the relationship between epidural analgesia and likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals, administered prior to vaginal delivery of a full-term, healthy neonate, significantly decrease lactation success at follow-up times ranging from… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Lactation, Analgesia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is open to all women, aged 18 and over, who are inpatients on the postpartum floor of MetroHealth Medical Center following the vaginal delivery of a single, healthy neonate. A neonate is "healthy" if neither of the following two conditions exists: 1) admission to the neonatal intensive care unit (NICU) following delivery and 2) pathologies, in either mother or baby, that would be reasonably expected to impede normal breast-feeding activity.
Who may be able to join
- Age 18 or over
- Vaginal delivery of a single live neonate at MetroHealth Medical Center's Main Campus
Who cannot join
- Delivery by Caesarean section
- Admission to the NICU following delivery
- Neonatal or maternal pathologies that would obviously impede normal breast-feeding activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Potential Determinants of Breast-Feeding Probability: Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Feeding Behavior
Presently, the literature addressing the relationship between epidural analgesia and likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals, administered prior to vaginal delivery of a full-term, healthy neonate, significantly decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum. One proposed mechanism is that analgesics, by decreasing maternal pain during labor, decrease maternal endorphin production and result in the transmission of lower endorphin levels to the neonate during breast-feeding. Lower endorphin levels, in turn, may render the neonate less likely to suckle optimally. Other studies have found that epidural analgesia does not significantly decrease lactation success when used during the vaginal delivery of a full-term, healthy neonate.
Although most studies to date have compared the breast-feeding success of epidural recipients and non-recipients at various points postpartum, they do not specifically note whether deficient feeding behaviors on the part of the infant contribute to failed breast-feeding. The present study uses the LATCH assessment tool to score the infant's ability to latch onto the breast and the presence of audible swallowing, as well as the mother's level of physical comfort with breast feeding, whether she can successfully position the infant for feeding on her own, and whether her nipples are inverted, everted, or flat. Thus, the LATCH assessment enables the separation of multiple factors that may contribute to breast-feeding failure. A multivariate regression analysis will determine how strongly the probability of breast-feeding at hospital discharge correlates with epidural duration, LATCH scores, and beta-endorphin concentrations in colostrum.
- Conditions
- Breastfeeding, Lactation, Analgesia
- Keywords
- epidural, beta-endorphins, breast-feeding, colostrum, feeding
- Medical subject headings
- Breast Feeding, Agnosia
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 |
|---|---|---|
| Epidural recipients | Subjects who received epidural analgesia during labor | |
| Non-epidural recipients | Subjects who did not receive epidural analgesia during labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast-Feeding at Discharge
The primary outcome measure is whether the subject is breast-feeding her infant, either exclusively or with bottle supplementation, at the time of hospital discharge.
Measured: Entire duration of postpartum hospital stay, 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 posted31 Aug 2010 (estimated)
Why it stopped: Withdrawn from IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Charles E Smith, M.D., Study director, Dept. of Anesthesiology, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191970
- Sponsor's protocol ID
- 1-Szabo
- Status last verified
- Jun 2018
- First submitted
- 27 Aug 2010
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
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 16306734Chang ZM, Heaman MI. Epidural analgesia during labor and delivery: effects on the initiation and continuation of effective breastfeeding. J Hum Lact. 2005 Aug;21(3):305-14; quiz 315-9, 326. doi: 10.1177/0890334405277604.
PubMed 16113019Henderson 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 14717315Zanardo V, Nicolussi S, Carlo G, Marzari F, Faggian D, Favaro F, Plebani M. Beta endorphin concentrations in human milk. J Pediatr Gastroenterol Nutr. 2001 Aug;33(2):160-4. doi: 10.1097/00005176-200108000-00012.
PubMed 11568517Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006 Nov;22(4):391-7. doi: 10.1177/0890334406293161.
PubMed 17062784Volmanen P, Valanne J, Alahuhta S. Breast-feeding problems after epidural analgesia for labour: a retrospective cohort study of pain, obstetrical procedures and breast-feeding practices. Int J Obstet Anesth. 2004 Jan;13(1):25-9. doi: 10.1016/S0959-289X(03)00104-3.
PubMed 15321436Gray L, Miller LW, Philipp BL, Blass EM. Breastfeeding is analgesic in healthy newborns. Pediatrics. 2002 Apr;109(4):590-3. doi: 10.1542/peds.109.4.590.
PubMed 11927701
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Potential Determinants of Breast-Feeding Probability: Epidural Analgesia, Beta-Endorphin Concentrations in Colostrum, and Infant Feeding Behavior
- ClinicalTrials.gov ID
- NCT01191970
- Acronym / sponsor ID
- 1-Szabo
- Conditions
- Breastfeeding, Lactation, Analgesia
- Keywords
- epidural, beta-endorphins, breast-feeding, colostrum, feeding
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawn from IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- First posted
- 31 Aug 2010 (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.
Presently, the literature addressing the relationship between epidural analgesia and likelihood of breast-feeding is inconclusive. Numerous studies have found that epidurals, administered prior to vaginal delivery of a full-term, healthy neonate, significantly decrease lactation success at follow-up times ranging from 24 hours to 6 months postpartum. One proposed mechanism is that analgesics, by decreasing maternal pain during labor, decrease maternal endorphin production and result in the transmission of lower endorphin levels to the neonate during breast-feeding. Lower endorphin levels, in turn, may render the neonate less likely to suckle optimally. Other studies have found that epidural analgesia does not significantly decrease lactation success when used during the vaginal delivery of a full-term, healthy neonate.
Although most studies to date have compared the breast-feeding success of epidural recipients and non-recipients at various points postpartum, they do not specifically note whether deficient feeding behaviors on the part of the infant contribute to failed breast-feeding. The present study uses the LATCH assessment tool to score the infant's ability to latch onto the breast and the presence of audible swallowing, as well as the mother's level of physical comfort with breast feeding, whether she can successfully position the infant for feeding on her own, and whether her nipples are inverted, everted, or flat. Thus, the LATCH assessment enables the separation of multiple factors that may contribute to breast-feeding failure. A multivariate regression analysis will determine how strongly the probability of breast-feeding at hospital discharge correlates with epidural duration, LATCH scores, and beta-endorphin concentrations in colostrum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural recipients | – | –Subjects who received epidural analgesia during labor |
| Non-epidural recipients | – | –Subjects who did not receive epidural analgesia during labor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is open to all women, aged 18 and over, who are inpatients on the postpartum floor of MetroHealth Medical Center following the vaginal delivery of a single, healthy neonate. A neonate is "healthy" if neither of the following two conditions exists: 1) admission to the neonatal intensive care unit (NICU) following delivery and 2) pathologies, in either mother or baby, that would be reasonably expected to impede normal breast-feeding activity.
Key inclusion criteria (2 listed)
- Age 18 or over
- Vaginal delivery of a single live neonate at MetroHealth Medical Center's Main Campus
Key exclusion criteria (3 listed)
- Delivery by Caesarean section
- Admission to the NICU following delivery
- Neonatal or maternal pathologies that would obviously impede normal breast-feeding activity
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
Breast-Feeding at Discharge
Time frame: Entire duration of postpartum hospital stay, average 2 days
The primary outcome measure is whether the subject is breast-feeding her infant, either exclusively or with bottle supplementation, at the time of hospital discharge.
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 14 Jun 2018.
- 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 16113019Chang ZM, Heaman MI. Epidural analgesia during labor and delivery: effects on the initiation and continuation of effective breastfeeding. J Hum Lact. 2005 Aug;21(3):305-14; quiz 315-9, 326. doi: 10.1177/0890334405277604.
- 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 11568517Zanardo V, Nicolussi S, Carlo G, Marzari F, Faggian D, Favaro F, Plebani M. Beta endorphin concentrations in human milk. J Pediatr Gastroenterol Nutr. 2001 Aug;33(2):160-4. doi: 10.1097/00005176-200108000-00012.
- Background: PubMed 17062784Kumar SP, Mooney R, Wieser LJ, Havstad S. The LATCH scoring system and prediction of breastfeeding duration. J Hum Lact. 2006 Nov;22(4):391-7. doi: 10.1177/0890334406293161.
- Background: PubMed 15321436Volmanen P, Valanne J, Alahuhta S. Breast-feeding problems after epidural analgesia for labour: a retrospective cohort study of pain, obstetrical procedures and breast-feeding practices. Int J Obstet Anesth. 2004 Jan;13(1):25-9. doi: 10.1016/S0959-289X(03)00104-3.
- Background: PubMed 11927701Gray L, Miller LW, Philipp BL, Blass EM. Breastfeeding is analgesic in healthy newborns. Pediatrics. 2002 Apr;109(4):590-3. doi: 10.1542/peds.109.4.590.
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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.
Charles E Smith, M.D. study director
Dept. of Anesthesiology, MetroHealth 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 Breastfeeding and Lactation, run by MetroHealth 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 2 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 14 Jun 2018. 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?
Breast-Feeding at Discharge (time frame: Entire duration of postpartum hospital stay, average 2 days). 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 NCT01191970, which also lists 8 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 14 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.