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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding at 6 Weeks Post Delivery | Breastfeeding continuing at 6 weeks after delivery of the baby. | 6 weeks post delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding at 3 Months After Delivery | Breastfeeding at 3 months after delivery of baby | 3 months after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Fentanyl Dose (Micrograms) | Total cumulative dose of fentanyl in micrograms | Time of epidural catheter removal |
| Plasma Fentanyl Concentration (ng/mL) | Blood plasma fentanyl concentraton (nanograms/milliliter). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paloma Toledo, M.D.,MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12583645 | Background | 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. | |
| 11138228 | Background | Riordan 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL Group 1: 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. |
| FG001 | Group 2 | 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 Group 2: 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. |
| FG002 | Group 3 | spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL Group 3: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL Group 1: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breastfeeding at 6 Weeks Post Delivery | Breastfeeding continuing at 6 weeks after delivery of the baby. | Posted | Count of Participants | Participants | 6 weeks post delivery |
|
6 Weeks after delivery
Subject contacted at 6 weeks to assess for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL Group 1: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Spinal headache reported by the subject to the study team. |
The study was limited because few of the participants required more than 150 micrograms of fentanyl for labor analgesia. This was the cut off for reduction of breastfeeding stated by earlier studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald | Northwerstern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| Group 2 | Drug | 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 3 | Drug | 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. |
|
|
| Time of epidural catheter removal |
| Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | Umbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL) | Immediately after delivery |
| 12421171 | Background | Rahm 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. |
| 16306734 | Background | Beilin 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. |
| 8176525 | Background | Jensen 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. |
| Delivered in under 90 minutes |
|
| Subject withdrew consent |
|
| BG001 | Group 2 | 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 Group 2: 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. |
| BG002 | Group 3 | spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL Group 3: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | Years of age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (kg/m∧ 2) | Mean | Inter-Quartile Range | Kilograms/meters squared |
|
| Number of times pregnant | Mean | Inter-Quartile Range | Number of times pregnant |
|
| Live Births | Median | Inter-Quartile Range | live births |
|
| Gestational Age (Days) | Mean | Inter-Quartile Range | Days |
|
| Duration of breastfeeding with last infant | Assessment of breastfeeding history with participants prior child. | Count of Participants | Participants |
|
| Reason for discontinuing breastfeeding with last child | Count of Participants | Participants |
|
| Support for breastfeeding | Count of Participants | Participants |
|
| Used an assistive device/nipple shield | Count of Participants | Participants |
|
| Skin-to-skin contact in the first 24 hours | Count of Participants | Participants |
|
| Time from delivery to initial breastfeeding | Count of Participants | Participants |
|
| Took a breastfeeding class or received breastfeeding education | Count of Participants | Participants |
|
| Breastfeeding motivational measurement scale | The breastfeeding motivational measurement tool scores the responses on a 0- poor to 140 good breastfeeding. | Median | Inter-Quartile Range | Score on a scale |
|
| Verbal rating score for analgesia satisfaction (0-100) | Verbal rating score for analgesia satisfaction on a scale of 0-poor to 100 good. | Mean | Full Range | score on a scale |
|
| Infant birth weight | Mean | Full Range | Kilograms |
|
| Mode of Delivery | Count of Participants | Participants |
|
| Breastfeeding at lactation consultant assessment n (%) | Count of Participants | Participants |
|
| LATCH score (0-2 for each factor) | LATCH is a breastfeeding charting system which provides a method for gathering information about individual breastfeeding sessions. The system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding. (0- poor and 2 is good) for each section for a possible total score of 0 which is poor to 10 good. | Mean | Full Range | Score on scale |
|
| Skin-to-skin contact in the first 24 hours post delivery | Count of Participants | Participants |
|
| OG002 | Group 3 | spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL Group 3: 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. |
|
|
|
| Secondary | Breastfeeding at 3 Months After Delivery | Breastfeeding at 3 months after delivery of baby | Posted | Count of Participants | Participants | 3 months after delivery |
|
|
|
|
| Other Pre-specified | Cumulative Fentanyl Dose (Micrograms) | Total cumulative dose of fentanyl in micrograms | Posted | Median | Inter-Quartile Range | fentalyl dose micrograms | Time of epidural catheter removal |
|
|
|
|
| Other Pre-specified | Plasma Fentanyl Concentration (ng/mL) | Blood plasma fentanyl concentraton (nanograms/milliliter). | Posted | Median | Inter-Quartile Range | ng/mL | Time of epidural catheter removal |
|
|
|
| Other Pre-specified | Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | Umbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL) | Posted | Median | Inter-Quartile Range | ng/mL | Immediately after delivery |
|
|
|
| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | Group 2 | 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 Group 2: 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. | 0 | 109 | 0 | 109 | 0 | 109 |
| EG002 | Group 3 | spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL Group 3: 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. | 0 | 112 | 0 | 112 | 0 | 112 |
|
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| D001519 | Behavior |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Lost to follow up |
|