Trial · NCT00443560
The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
NCT00443560, Completed, Northwestern University; results first posted 2011-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery. Trials, record NCT00443560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00443560
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
- NCT number
- NCT00443560
- Status
- Completed
- Enrollment
- 2,162 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Labor Pain, Pregnancy
- Interventions
- Case controlled analysis of epidural labor analgesia patterns
- First posted
- 2007-03-06
- Last updated
- 2014-04-14
- Results first posted
- 2011-07-21
- Limitations and caveats
- The retrospective design incurs the risk of unrecorded or unobserved data. The sample selected included all patients with neuraxial analgesia who underwent IVD, but a limited sample of SVD.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor | Second stage of labor up to 3 hours | At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued. |
| Secondary | Number of Participants With Breakthrough Pain in the First Stage of Labor | Supplemental analgesia in first stage of labor (<24 hours) | Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced. |
| Secondary | Duration of Labor Analgesia | Time form initiation of labor analgesia to delivery (up to 24 hours) | Time in minutes from initiation of labor analgesia until delivery of the infant |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor | Second stage of labor up to 3 hours | Analysis was per protocal | participants | NUMBER |
| SECONDARY | Number of Participants With Breakthrough Pain in the First Stage of Labor | Supplemental analgesia in first stage of labor (<24 hours) | Analysis was per protocol | participants | NUMBER |
| SECONDARY | Duration of Labor Analgesia | Time form initiation of labor analgesia to delivery (up to 24 hours) | Analysis was per protocal | minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor | Instrumental Vaginal Delivery (IVD) | 146 | participants | ||
| Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor | Spontaneous Vaginal Delivery (SVD) | 51 | participants | ||
| Number of Participants With Breakthrough Pain in the First Stage of Labor | Instrumental Vaginal Delivery (IVD) | Supplemental bolus | 802 | participants | |
| Number of Participants With Breakthrough Pain in the First Stage of Labor | Spontaneous Vaginal Delivery (SVD) | Supplemental bolus | 243 | participants | |
| Number of Participants With Breakthrough Pain in the First Stage of Labor | Instrumental Vaginal Delivery (IVD) | Infusion increase | 149 | participants | |
| Number of Participants With Breakthrough Pain in the First Stage of Labor | Spontaneous Vaginal Delivery (SVD) | Infusion increase | 87 | participants | |
| Number of Participants With Breakthrough Pain in the First Stage of Labor | Instrumental Vaginal Delivery (IVD) | Concentration increase | 32 | participants | |
| Number of Participants With Breakthrough Pain in the First Stage of Labor | Spontaneous Vaginal Delivery (SVD) | Concentration increase | 19 | participants | |
| Duration of Labor Analgesia | Instrumental Vaginal Delivery (IVD) | 420 | Inter-Quartile Range 300 to 570 | minutes | |
| Duration of Labor Analgesia | Spontaneous Vaginal Delivery (SVD) | 300 | Inter-Quartile Range 210 to 420 | minutes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Instrumental Vaginal Delivery (IVD) | 1,081 | |
| Overall Study | STARTED | Spontaneous Vaginal Delivery (SVD) | 1,081 | |
| Overall Study | COMPLETED | Instrumental Vaginal Delivery (IVD) | 1,021 | |
| Overall Study | COMPLETED | Spontaneous Vaginal Delivery (SVD) | 1,051 | |
| Overall Study | NOT COMPLETED | Instrumental Vaginal Delivery (IVD) | 60 | |
| Overall Study | NOT COMPLETED | Spontaneous Vaginal Delivery (SVD) | 30 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Instrumental Vaginal Delivery (IVD) | ||
| Total, all-cause mortality | Spontaneous Vaginal Delivery (SVD) | ||
| Total, other adverse events | Instrumental Vaginal Delivery (IVD) | 0 | 0 |
| Total, other adverse events | Spontaneous Vaginal Delivery (SVD) | 0 | 0 |
| Total, serious adverse events | Instrumental Vaginal Delivery (IVD) | 0 | 0 |
| Total, serious adverse events | Spontaneous Vaginal Delivery (SVD) | 0 | 0 |
Source ClinicalTrials.gov
Papers10
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Instrumental Vaginal Delivery (IVD) vs Spontaneous Vaginal Delivery (SVD): Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor |
Source Trial comparisons
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/NCT00443560
GET https://conductscience.org/api/trials/v1/NCT00443560/registered