Comparison · NCT01621230-e82d232d
Epidural Fentanyl vs Epidural Bupivacaine Plus Fentanyl (Bupivacaine): Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Epidural Fentanyl vs Epidural Bupivacaine Plus Fentanyl (Bupivacaine): Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min. Trial comparisons, record NCT01621230-e82d232d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01621230-e82d232d
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0897 | 0.0542 | 0.145 | wilson | |
| Risk in group 2 | 0.0714 | 0.0403 | 0.123 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0183 | -0.0446 | 0.0817 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.589 | 2.68 | log | |
| Odds ratio, group 1 over group 2 | 1.28 | 0.563 | 2.92 | log | |
| Number needed to treat, for one more participant with the outcome on Epidural Fentanyl than on Epidural Bupivacaine Plus Fentanyl (Bupivacaine) | 54.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Epidural Fentanyl | A continuous epidural infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 ml/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 mL/hr for pain. Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed.~Epidural fentanyl: The subjects will receive epidural fentanyl 10 mcg/mL with the rate of 10mL/hr. | 14 | 156 | OG000 |
| Group 2 | Epidural Bupivacaine Plus Fentanyl (Bupivacaine) | A continuous epidural infusion of bupivacaine plus fentanyl during the second stage (i.e. 10 cm dilation) of labor. Epidural infusion are 10 ml/hr basal infusion plus 5 ml/hr demand dose via patient-controlled epidural analgesia (PCEA). Meperidine 25 mg intravenously every 1 hour for breakthrough pain as needed .~Epidural Bupivacaine plus fentanyl: The subjects will receive 0.125% bupivacaine with fentanyl 2 mcg/mL at a rate of 10 mL/hr. | 11 | 154 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min
- Description
- Number of participants whose newborns received an APGAR score of \<=3 at 1 min. A lower APGAR score represents poor health or a worsening in the Outcome,
- Time frame
- At the time of Delivery, up to 3 hours
- Population
Source ClinicalTrials.gov
Trial
- Title
- Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor
- NCT number
- NCT01621230
- Phases
- PHASE4
- Conditions
- Pregnancy
- Interventions
- Epidural Bupivacaine plus fentanyl, Epidural fentanyl
- Lead sponsor
- University of Texas Southwestern Medical Center
- Results first posted
- 2020-08-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01621230?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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