PainNCT01074190
The Effect of Neuraxial Analgesia on Maternal Breastfeeding
A study testing Group 1, Group 2 and Group 3 in people with Pain and Breastfeeding, run by Northwestern University at 1 site in United States.
Trial summary
A previous randomized trial showed a possible negative association with labor neuraxial analgesia with high compared to low doses of fentanyl, and breastfeeding at 6 weeks postpartum. The significance of this study would be to validate or refute these findings. 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
- Pain, Breastfeeding
- What is being tested?
- Group 1, Group 2 and Group 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2016
- Phase
- Interventional
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
Who may be able to join
- Age 18 and above
- English speaking
- Term gestation (> 38 weeks)
- Parous parturients presenting for attempted vaginal delivery with a cervical dilation less than 8 cm
- They must request neuraxial labor analgesia
- Have previously successfully breastfed their child postpartum for at least 6 weeks
- Are expressing an interest in exclusively breastfeeding postpartum
Who cannot join
- Under 18 years of age
- Parturients who have received parental opioids during labor or have taken opioids prenatally
- Patients whose neuraxial analgesia failed due to abnormal spinal anatomy including scoliosis or previous spinal instrumentation
- Supplemental epidural opioids during labor
- Had an expedited labor with the delivery of the fetus less than 90 minutes from the placement of the neuraxial anesthestic
- Underwent cesarean delivery
- Received general analgesia for an unanticipated postpartum procedure
- Dropout criteria include patients who wished to be taken out of the study or were lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
A previous randomized trial showed a possible negative association with labor neuraxial analgesia with high compared to low doses of fentanyl, and breastfeeding at 6 weeks postpartum. The significance of this study would be to validate or refute these findings. In addition, we hope to better evaluate the impact of cumulative dose of fentanyl on breastfeeding success in the initial postpartum period as well as at 6 weeks and 6 months post delivery. In order to better assess the quality of breastfeeding, we will utilize a validated breastfeeding assessment tool, LATCH (Latch, Audible swallowing, Type of Nipple, Comfort, and Help). This validated tool can assess maternal and infant variables, define areas of needed intervention, and determine priorities in providing patient teaching. The LATCH assessment has been shown to be a predictor of breastfeeding duration. We also plan to vary the dosage of fentanyl analgesia to determine the relationship between doses below 150 micrograms and changes in breastfeeding assessments. If a clear association between decreased breastfeeding and total fentanyl is identified, then regimens to reduce cumulative doses of fentanyl can be developed to improve the likelihood of breastfeeding success in mothers that desire to breastfeed.
Prior observational studies have inferred epidurals negatively affect breastfeeding by decreasing maternal plasma oxytocin release which may adversely affect infant neurobehavioral development. In a study by Beilin et al., it was reported that mothers receiving a high cumulative dose (> 150 microgram) epidural fentanyl were more likely to have stopped nursing 6 weeks postpartum compared with groups receiving no fentanyl or those receiving < 150 microgram. The study however, was underpowered to detect differences in breastfeeding prior to hospital discharge. In addition, the breastfeeding assessment tool utilized resulted in binary assessments, and therefore, a global rating of the quality of breastfeeding was not available.
Read the detailed description
Participants in this study will be asked to complete a questionnaire called the Intrinsic Motivation Inventory (IMI).
Subjects will be randomized at the time they request neuraxial analgesia to one of three groups: Group 1: patient controlled epidural analgesia (PCEA) with bupivacaine 1mg/mL; Group 2: PCEA with fentanyl 1 mcg/mL plus bupivacaine 0.8 mg/mL; Group 3: PCEA with fentanyl 2 mcg/mL plus bupivacaine 0.625 mg/mL. Labor analgesia will be initiated in all groups using fentanyl 15 mcg plus bupivacaine 2.5 mg administered intrathecally. A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
The patient as well as individuals who evaluate the study patient will be blinded to the group assignment. Samples of maternal venous blood ½ teaspoon (2 mls) and cord blood 2ml (1/2 teaspoon) will be collected after the delivery of the fetus. Blood concentrations of fentanyl and bupivacaine will be ascertained using high performance liquid chromatography (HPLC) analysis. Success of breastfeeding using the LATCH assessment tool will be measured by the lactation nurses within 24 hrs of delivery. At 6 weeks and at 3 months postpartum, follow-up phone calls by the anesthesia service will be made to assess for duration of breastfeeding. Also, the patient's obstetrician will be contacted to obtain the patient's Edinburgh Postnatal Depression Score to assess for postpartum depression, which may be a variable in decreasing breastfeeding success.
- Conditions
- Pain, Breastfeeding
- Being tested
- Group 1, Group 2, Group 3
- Keywords
- Epidural Labor Analgesia, Pain, Infant, Breastfeeding
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Drug
Also called bupivacaine 1mg/ml
A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
Group 2Drug
Also called fentanyl 1mcg/ml plus bupivacaine 0.8 mg/ml
A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
Group 3Drug
Also called fentanyl 2mcg/ml plus bupivacaine 0.625 mg/ml
A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL Receives: Drug: Group 1 |
| Group 2 | Experimental | spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg spinal followed by a PCEA infusion of fentanyl 1 micrograms/mL plus bupivacaine 0.8 mg/mL Receives: Drug: Group 2 |
| Group 3 | Active comparator | spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL Receives: Drug: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding at 6 Weeks Post Delivery
Breastfeeding continuing at 6 weeks after delivery of the baby.
Measured: 6 weeks post delivery
Secondary outcomes (1)
Breastfeeding at 3 Months After Delivery
Breastfeeding at 3 months after delivery of baby
Measured: 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paloma Toledo, Northwestern University
- Investigators
- Paloma Toledo, M.D.,MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074190
- Sponsor's protocol ID
- STU00007275
- Status last verified
- Apr 2022
- First submitted
- 22 Feb 2010
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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 12583645Riordan J, Gross A, Angeron J, Krumwiede B, Melin J. The effect of labor pain relief medication on neonatal suckling and breastfeeding duration. J Hum Lact. 2000 Feb;16(1):7-12. doi: 10.1177/089033440001600103.
PubMed 11138228Rahm VA, Hallgren A, Hogberg H, Hurtig I, Odlind V. Plasma oxytocin levels in women during labor with or without epidural analgesia: a prospective study. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1033-9. doi: 10.1034/j.1600-0412.2002.811107.x.
PubMed 12421171Beilin 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 16306734Jensen 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