N/A
N=345
The Effect of Neuraxial Analgesia on Maternal Breastfeeding
Pain · Breastfeeding
Bottom Line
View on ClinicalTrials.gov: NCT01074190 ↗Enrolled (actual)
345
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Breastfeeding at 6 Weeks Post Delivery — 100; 99; 102; 3 Participants — p=.34
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group 1 (Drug); Group 2 (Drug); Group 3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breastfeeding at 6 Weeks Post Delivery |
100; 99; 102; 3; 2; 6 | .34 |
| SECONDARY Breastfeeding at 3 Months After Delivery |
94; 96; 93; 6; 4; 12 | .1 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01074190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.