Trial · NCT01074190
The Effect of Neuraxial Analgesia on Maternal Breastfeeding
NCT01074190, Not applicable, Completed, Northwestern University; results first posted 2022-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Neuraxial Analgesia on Maternal Breastfeeding. Trials, record NCT01074190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01074190
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Neuraxial Analgesia on Maternal Breastfeeding
- NCT number
- NCT01074190
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 345 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Pain, Breastfeeding
- Interventions
- Group 1, Group 2, Group 3
- First posted
- 2010-02-24
- Last updated
- 2022-04-05
- Results first posted
- 2022-04-05
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Breastfeeding at 6 Weeks Post Delivery | 6 weeks post delivery | Breastfeeding continuing at 6 weeks after delivery of the baby. |
| Secondary | Breastfeeding at 3 Months After Delivery | 3 months after delivery | Breastfeeding at 3 months after delivery of baby |
| Other | Cumulative Fentanyl Dose (Micrograms) | Time of epidural catheter removal | Total cumulative dose of fentanyl in micrograms |
| Other | Plasma Fentanyl Concentration (ng/mL) | Time of epidural catheter removal | Blood plasma fentanyl concentraton (nanograms/milliliter). |
| Other | Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | Immediately after delivery | Umbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Breastfeeding at 6 Weeks Post Delivery | 6 weeks post delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Breastfeeding at 3 Months After Delivery | 3 months after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Cumulative Fentanyl Dose (Micrograms) | Time of epidural catheter removal | fentalyl dose micrograms | MEDIAN | |
| OTHER_PRE_SPECIFIED | Plasma Fentanyl Concentration (ng/mL) | Time of epidural catheter removal | ng/mL | MEDIAN | |
| OTHER_PRE_SPECIFIED | Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | Immediately after delivery | ng/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Breastfeeding at 6 Weeks Post Delivery | Group 1 | Currently breast feeding | 100 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 2 | Currently breast feeding | 99 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 3 | Currently breast feeding | 102 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 1 | Not breastfeeding | 3 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 2 | Not breastfeeding | 2 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 3 | Not breastfeeding | 6 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 1 | Lost to follow up | 8 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 2 | Lost to follow up | 8 | Participants | |
| Breastfeeding at 6 Weeks Post Delivery | Group 3 | Lost to follow up | 4 | Participants | |
| Breastfeeding at 3 Months After Delivery | Group 1 | Breastfeeding | 94 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 115 | |
| Overall Study | STARTED | Group 2 | 115 | |
| Overall Study | STARTED | Group 3 | 115 | |
| Overall Study | COMPLETED | Group 1 | 111 | |
| Overall Study | COMPLETED | Group 2 | 109 | |
| Overall Study | COMPLETED | Group 3 | 112 | |
| Overall Study | NOT COMPLETED | Group 1 | 4 | |
| Overall Study | NOT COMPLETED | Group 2 | 6 | |
| Overall Study | NOT COMPLETED | Group 3 | 3 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Spinal headache | Nervous system disorders | Group 1 | 0 | 111 | 0 |
| other | Spinal headache | Nervous system disorders | Group 2 | 0 | 109 | 0 |
| other | Spinal headache | Nervous system disorders | Group 3 | 0 | 112 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | 0 | 111 |
| Total, all-cause mortality | Group 2 | 0 | 109 |
| Total, all-cause mortality | Group 3 | 0 | 112 |
| Total, other adverse events | Group 1 | 0 | 111 |
| Total, other adverse events | Group 2 | 0 | 109 |
| Total, other adverse events | Group 3 | 0 | 112 |
| Total, serious adverse events | Group 1 | 0 | 111 |
| Total, serious adverse events | Group 2 | 0 | 109 |
| Total, serious adverse events | Group 3 | 0 | 112 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01074190
GET https://conductscience.org/api/trials/v1/NCT01074190/results?page=2