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The Effect of Neuraxial Analgesia on Maternal Breastfeeding

The Effect of Neuraxial Analgesia on Maternal Breastfeeding

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01074190
Enrollment
345
Registered
2010-02-24
Start date
2010-01-31
Completion date
2016-12-31
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Pain

Keywords

Epidural Labor Analgesia, Pain, Infant, Breastfeeding

Brief 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. 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.

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.

Interventions

DRUGGroup 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.

DRUGGroup 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.

DRUGGroup 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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding at 6 Weeks Post Delivery6 weeks post deliveryBreastfeeding continuing at 6 weeks after delivery of the baby.

Secondary

MeasureTime frameDescription
Breastfeeding at 3 Months After Delivery3 months after deliveryBreastfeeding at 3 months after delivery of baby

Other

MeasureTime frameDescription
Cumulative Fentanyl Dose (Micrograms)Time of epidural catheter removalTotal cumulative dose of fentanyl in micrograms
Plasma Fentanyl Concentration (ng/mL)Time of epidural catheter removalBlood plasma fentanyl concentraton (nanograms/milliliter).
Umbilical Vein Plasma Fentanyl Concentration (ng/mL)Immediately after deliveryUmbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL)

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
111
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.
109
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.
112
Total332

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDelivered in under 90 minutes021
Overall StudyEmergency Cesarean Delivery121
Overall StudyProtocol Violation210
Overall StudySubject withdrew consent111

Baseline characteristics

CharacteristicGroup 1Group 2Group 3Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
111 Participants109 Participants112 Participants332 Participants
Age, Continuous33 Years of age34 Years of age34 Years of age34 Years of age
Body Mass Index (kg/m∧ 2)28 Kilograms/meters squared28 Kilograms/meters squared29 Kilograms/meters squared28 Kilograms/meters squared
Breastfeeding at lactation consultant assessment n (%)
Consultant not available
5 Participants4 Participants11 Participants20 Participants
Breastfeeding at lactation consultant assessment n (%)
No
8 Participants9 Participants3 Participants20 Participants
Breastfeeding at lactation consultant assessment n (%)
Yes
98 Participants96 Participants98 Participants292 Participants
Breastfeeding motivational measurement scale119 Score on a scale117 Score on a scale117 Score on a scale118 Score on a scale
Duration of breastfeeding with last infant
3-6 months
20 Participants31 Participants30 Participants81 Participants
Duration of breastfeeding with last infant
Greater than 6 months
82 Participants72 Participants73 Participants227 Participants
Duration of breastfeeding with last infant
Less than three months
9 Participants6 Participants9 Participants24 Participants
Gestational Age (Days)277 Days276 Days276 Days276 Days
Infant birth weight3.54 Kilograms3.61 Kilograms3.57 Kilograms3.56 Kilograms
LATCH score (0-2 for each factor)
Audible swallowing
2 Score on scale2 Score on scale2 Score on scale2 Score on scale
LATCH score (0-2 for each factor)
Comfort (breast/nipple)
2 Score on scale2 Score on scale2 Score on scale2 Score on scale
LATCH score (0-2 for each factor)
Hold (positioning)
1 Score on scale1 Score on scale1 Score on scale1 Score on scale
LATCH score (0-2 for each factor)
Latch
2 Score on scale2 Score on scale2 Score on scale2 Score on scale
LATCH score (0-2 for each factor)
Total Score maximum 0-10
8.5 Score on scale8 Score on scale9 Score on scale8.5 Score on scale
LATCH score (0-2 for each factor)
Type of nipple
2 Score on scale2 Score on scale2 Score on scale2 Score on scale
Live Births1 live births1 live births1 live births1 live births
Mode of Delivery
Assisted Vaginal Delivery
0 Participants1 Participants2 Participants3 Participants
Mode of Delivery
Cesarean Delivery
0 Participants1 Participants0 Participants1 Participants
Mode of Delivery
Vaginal Delivery
111 Participants107 Participants110 Participants328 Participants
Number of times pregnant3 Number of times pregnant3 Number of times pregnant2 Number of times pregnant3 Number of times pregnant
Reason for discontinuing breastfeeding with last child
Child eating solid foods/teething
21 Participants17 Participants19 Participants57 Participants
Reason for discontinuing breastfeeding with last child
Difficulty with breastfeeding
9 Participants10 Participants5 Participants24 Participants
Reason for discontinuing breastfeeding with last child
Inadequate milk production
11 Participants19 Participants14 Participants44 Participants
Reason for discontinuing breastfeeding with last child
Lack of time
3 Participants2 Participants9 Participants14 Participants
Reason for discontinuing breastfeeding with last child
Perceived time to stop
22 Participants22 Participants20 Participants64 Participants
Reason for discontinuing breastfeeding with last child
Pregnancy
10 Participants9 Participants9 Participants28 Participants
Reason for discontinuing breastfeeding with last child
Return to work
35 Participants30 Participants36 Participants101 Participants
Region of Enrollment
United States
111 participants109 participants112 participants332 participants
Sex: Female, Male
Female
111 Participants109 Participants112 Participants332 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants
Skin-to-skin contact in the first 24 hours
0-25%
35 Participants33 Participants43 Participants111 Participants
Skin-to-skin contact in the first 24 hours
25-50%
28 Participants41 Participants39 Participants108 Participants
Skin-to-skin contact in the first 24 hours
50-75%
23 Participants27 Participants25 Participants75 Participants
Skin-to-skin contact in the first 24 hours
75-100%
13 Participants5 Participants3 Participants21 Participants
Skin-to-skin contact in the first 24 hours
Did not remember
2 Participants3 Participants2 Participants7 Participants
Skin-to-skin contact in the first 24 hours
Missing Data
10 Participants0 Participants0 Participants10 Participants
Skin-to-skin contact in the first 24 hours post delivery
0-25%
72 Participants70 Participants71 Participants213 Participants
Skin-to-skin contact in the first 24 hours post delivery
25-50%
19 Participants2 Participants17 Participants38 Participants
Skin-to-skin contact in the first 24 hours post delivery
50-75%
9 Participants8 Participants11 Participants28 Participants
Skin-to-skin contact in the first 24 hours post delivery
75-100%
5 Participants0 Participants2 Participants7 Participants
Support for breastfeeding
Missing Data
1 Participants0 Participants0 Participants1 Participants
Support for breastfeeding
Moderate
9 Participants13 Participants18 Participants40 Participants
Support for breastfeeding
Strong
101 Participants94 Participants93 Participants288 Participants
Support for breastfeeding
Weak
0 Participants2 Participants1 Participants3 Participants
Time from delivery to initial breastfeeding
0 to 1 hour
90 Participants80 Participants79 Participants249 Participants
Time from delivery to initial breastfeeding
1 to 3 hours
9 Participants19 Participants16 Participants44 Participants
Time from delivery to initial breastfeeding
4 to 10 hours
4 Participants4 Participants5 Participants13 Participants
Time from delivery to initial breastfeeding
Did not remember
4 Participants2 Participants5 Participants11 Participants
Time from delivery to initial breastfeeding
Greater than 10 hours
4 Participants4 Participants7 Participants15 Participants
Took a breastfeeding class or received breastfeeding education
Did not take class or no response
49 Participants57 Participants50 Participants156 Participants
Took a breastfeeding class or received breastfeeding education
Took breastfeeding class
62 Participants52 Participants62 Participants176 Participants
Used an assistive device/nipple shield
Did not use device or no response
92 Participants87 Participants94 Participants273 Participants
Used an assistive device/nipple shield
Used Device
19 Participants22 Participants18 Participants59 Participants
Verbal rating score for analgesia satisfaction (0-100)91 score on a scale91 score on a scale86 score on a scale89 score on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1110 / 1090 / 112
other
Total, other adverse events
0 / 1110 / 1090 / 112
serious
Total, serious adverse events
0 / 1110 / 1090 / 112

Outcome results

Primary

Breastfeeding at 6 Weeks Post Delivery

Breastfeeding continuing at 6 weeks after delivery of the baby.

Time frame: 6 weeks post delivery

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Breastfeeding at 6 Weeks Post DeliveryNot breastfeeding3 Participants
Group 1Breastfeeding at 6 Weeks Post DeliveryCurrently breast feeding100 Participants
Group 1Breastfeeding at 6 Weeks Post DeliveryLost to follow up8 Participants
Group 2Breastfeeding at 6 Weeks Post DeliveryNot breastfeeding2 Participants
Group 2Breastfeeding at 6 Weeks Post DeliveryCurrently breast feeding99 Participants
Group 2Breastfeeding at 6 Weeks Post DeliveryLost to follow up8 Participants
Group 3Breastfeeding at 6 Weeks Post DeliveryCurrently breast feeding102 Participants
Group 3Breastfeeding at 6 Weeks Post DeliveryLost to follow up4 Participants
Group 3Breastfeeding at 6 Weeks Post DeliveryNot breastfeeding6 Participants
p-value: 0.34Chi-squared
Secondary

Breastfeeding at 3 Months After Delivery

Breastfeeding at 3 months after delivery of baby

Time frame: 3 months after delivery

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Breastfeeding at 3 Months After DeliveryNot breastfeeding6 Participants
Group 1Breastfeeding at 3 Months After DeliveryBreastfeeding94 Participants
Group 1Breastfeeding at 3 Months After DeliveryLost to follow up11 Participants
Group 2Breastfeeding at 3 Months After DeliveryNot breastfeeding4 Participants
Group 2Breastfeeding at 3 Months After DeliveryBreastfeeding96 Participants
Group 2Breastfeeding at 3 Months After DeliveryLost to follow up9 Participants
Group 3Breastfeeding at 3 Months After DeliveryBreastfeeding93 Participants
Group 3Breastfeeding at 3 Months After DeliveryLost to follow up7 Participants
Group 3Breastfeeding at 3 Months After DeliveryNot breastfeeding12 Participants
p-value: 0.1Chi-squared
Other Pre-specified

Cumulative Fentanyl Dose (Micrograms)

Total cumulative dose of fentanyl in micrograms

Time frame: Time of epidural catheter removal

ArmMeasureValue (MEDIAN)
Group 1Cumulative Fentanyl Dose (Micrograms)15 fentalyl dose micrograms
Group 2Cumulative Fentanyl Dose (Micrograms)78 fentalyl dose micrograms
Group 3Cumulative Fentanyl Dose (Micrograms)139 fentalyl dose micrograms
TotalCumulative Fentanyl Dose (Micrograms)78 fentalyl dose micrograms
Comparison: A sample size of 315 achieves 80% power to detect a difference among groups using a 2 degrees of freedom Chi-Square Test with a significance level (alpha) of 0.05.p-value: 0.1Chi-squared
Other Pre-specified

Plasma Fentanyl Concentration (ng/mL)

Blood plasma fentanyl concentraton (nanograms/milliliter).

Time frame: Time of epidural catheter removal

ArmMeasureValue (MEDIAN)
Group 1Plasma Fentanyl Concentration (ng/mL).01 ng/mL
Group 2Plasma Fentanyl Concentration (ng/mL).07 ng/mL
Group 3Plasma Fentanyl Concentration (ng/mL).13 ng/mL
TotalPlasma Fentanyl Concentration (ng/mL).07 ng/mL
Other Pre-specified

Umbilical Vein Plasma Fentanyl Concentration (ng/mL)

Umbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL)

Time frame: Immediately after delivery

ArmMeasureValue (MEDIAN)
Group 1Umbilical Vein Plasma Fentanyl Concentration (ng/mL).005 ng/mL
Group 2Umbilical Vein Plasma Fentanyl Concentration (ng/mL).03 ng/mL
Group 3Umbilical Vein Plasma Fentanyl Concentration (ng/mL).06 ng/mL
TotalUmbilical Vein Plasma Fentanyl Concentration (ng/mL).03 ng/mL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026