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NCT01074190 · ClinicalTrials.gov registry record · NA
The Effect of Neuraxial Analgesia on Maternal Breastfeeding
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 345
- Enrollment target
NCT01074190 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 345 participants.
The verdict
NCT01074190, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 345 participants
- Enrollment target
Study 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
Interventions
- DRUG Group 1
- DRUG Group 2
- DRUG Group 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01074190
The ClinicalTrials.gov registry entry for NCT01074190 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Group 1 is the first listed.
NCT01074190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01074190 about?
NCT01074190 is a clinical study titled "The Effect of Neuraxial Analgesia on Maternal Breastfeeding". 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 evaluat...
What is the current status of trial NCT01074190?
This trial is currently completed. It is a NA study. The enrollment target is 345 participants. The study started on 2010-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01074190?
The interventions under investigation include: Group 1 (DRUG), Group 2 (DRUG), Group 3 (DRUG).
Who is sponsoring clinical trial NCT01074190?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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