Comparing Effectiveness of CSE Versus DPE for Labor Analgesia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparing Effectiveness of CSE Versus DPE for Labor Analgesia (NCT05068661), a randomized phase 4 study. The primary outcome is Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One).

2. Clinical Question

3. Trial Design

This is a randomized controlled trial listed as phase 4. Its recorded allocation is randomized, masking is quadruple, and the trial model is sequential. The sponsor is Duke University. The record lists enrollment of 101 and status as completed. Although the results report outcome denominators of 48 for CSE and 52 for DPE, those denominators do not account for the enrollment figure by themselves; the reason for the difference is not reported in the registry record. The timing of enrollment and completion is recorded in the registry, but is not necessary for interpreting the primary comparison.

The two arms compare techniques for initiating and maintaining labor analgesia. Both descriptions include patient-controlled epidural analgesia as part of maintenance, while their initiation procedures differ. The registry identifies ropivacaine and bupivacaine injectable solutions among the interventions. The full CSE maintenance description is truncated in the record, so additional procedural details should not be inferred.

The primary outcome is a participant count for a composite block-quality event, assessed from epidural placement to delivery, up to 32 hours. The registry also lists nine secondary outcome measures, including maternal adverse events, motor block, labor and delivery measures, anesthetic use, patient-controlled boluses, mode of delivery, and postpartum satisfaction. The record lists nine analyses, while eight secondary outcomes are identified as posted. Only the secondary outcome details displayed in the results section should be treated as available evidence.

The registry record does not report the trial’s original sample-size justification, a detailed statistical analysis plan, interim analyses, or the identities of the masked groups. Those omissions limit what can be said about design choices, analysis conduct, and how the posted analyses relate to any prespecified plan.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Participants who completed the study.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One), measured over From placement of epidural to delivery of baby, up to 32 hours.

The primary endpoint counts participants who experienced at least one of five specified components of block quality. These are asymmetric block after 30 minutes of initiation, a top-up intervention, catheter adjustment, failed catheter requiring replacement, or failed epidural requiring general anesthesia or replacement neuraxial anesthesia for cesarean section. A participant is counted as having the composite outcome if any one or more of these components is present. The measure is assessed from epidural placement to delivery of the baby, up to 32 hours.

A composite endpoint can capture several ways that the study defines an unsatisfactory or problematic block in one summary measure. This can make the primary question broader than a question about any single component. At the same time, the combined count does not show which component accounts for the events or whether the components occur with similar frequency or importance. The registry record does not provide component-specific results, so the overall composite cannot be broken down further.

The endpoint is reported as a count of participants, with an arm denominator. The posted results show 16 participants with the outcome among 48 in the CSE arm and 13 among 52 in the DPE arm. These counts describe the observed composite events in the posted results; they do not, by themselves, establish a difference between techniques. The comparison and its uncertainty are considered in the interpretation and precision sections.

7. Results Posted in the Registry

• Dural Puncture Epidural: 25.0% (13/52) versus 33.3% (16/48) on control; risk difference -8.3 percentage points (95% CI -26.1 to 9.5), risk ratio 0.75 (0.40–1.39); unadjusted two-proportion z-test p = 0.359.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Participants With Motor Block as Measured by the Modified Bromage Score

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Dural Puncture Epidural: 19.2% (10/52) versus 27.1% (13/48) on control; risk difference -7.9 percentage points (95% CI -24.4 to 8.7), risk ratio 0.71 (0.34–1.47); unadjusted two-proportion z-test p = 0.351.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Dural Puncture Epidural and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Dural Puncture Epidural: 78.8% (41/52) versus 83.3% (40/48) on control; risk difference -4.5 percentage points (95% CI -19.8 to 10.8), risk ratio 0.95 (0.78–1.14); unadjusted two-proportion z-test p = 0.568.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Dural Puncture Epidural and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary measures spanning motor block, maternal adverse events, labor duration and epidural time, anesthetic dose, patient-controlled bolus use, mode of delivery, and postpartum satisfaction. The posted secondary information includes results for motor block and the number of participants who self-administered patient-controlled epidural analgesia boluses. Across these displayed results, the recalculated comparisons do not establish a clear difference between arms. The registry-reported analyses likewise do not provide clear evidence of a difference in those outcomes.

This broad pattern is compatible with the primary result: the displayed secondary comparisons do not resolve the uncertainty around the composite block-quality outcome. They should not be treated as substitutes for the primary endpoint, since they assess different outcomes. Nor does a lack of clear evidence in these secondary comparisons demonstrate that the arms are identical on the measured outcomes.

General statistical explanation: when a trial examines multiple secondary outcomes, each analysis creates another opportunity to observe a seemingly notable result by chance. Unless the analysis plan accounts for multiplicity, isolated secondary p-values carry less confirmatory weight than a prespecified primary analysis. The registry record does not report a multiplicity adjustment or a detailed hierarchy for interpreting secondary endpoints. The secondary results are therefore best used as descriptive context, not as independent proof of benefit or harm.

The record lists more secondary measures than are described with results in the detailed data. Results for secondary measures not displayed should not be inferred from the primary finding or from the available secondary comparisons. Their presence in the outcomes list identifies what was planned or registered, but does not establish a particular observed result.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Maternal Adverse Events
• Number of Participants With Motor Block as Measured by the Modified Bromage Score
• Duration of the Second Stage of Labor
• Total Labor Epidural Time
• Total Anesthetic Dose Required
• Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses
• Mode of Delivery
• Postpartum: Satisfaction With Analgesia Overall

9. Statistical Interpretation

10. Statistical Methods Explained

The primary result is a comparison of a binary outcome: each participant either had at least one component of the block-quality composite or did not. General statistical explanation: a binary outcome can be summarized within each arm by the number of participants with the event and the number assessed. A comparison then describes how the event frequency differs between arms. Here, the posted counts are 16 of 48 for CSE and 13 of 52 for DPE.

Absolute and relative comparisons

The re-calculation presents an absolute risk difference, with DPE compared with CSE. An absolute difference describes the gap between the two event proportions on the original probability scale. The estimate is -0.083. This sign indicates that the observed event proportion was lower in DPE in this comparison. The confidence interval, from -0.261 to 0.095, expresses uncertainty around that estimate. Because it covers values below and above zero, it does not rule out either a reduction or an increase in the event proportion.

The registry’s reported analysis uses a risk ratio instead. A risk ratio compares the event frequency in one arm with the event frequency in the other on a relative scale. The reported risk ratio is 0.75, with a 95% confidence interval from 0.40 to 1.39. For a risk ratio, the value that represents no relative difference is 1. The reported interval includes that value. The sponsor’s analysis reports p = 0.486 from a chi-squared method. These values are not interchangeable with the absolute risk difference or its p-value, because the measures and analysis are not the same. The registry record does not provide further detail on the sponsor’s implementation beyond the method and reported measure.

Confidence intervals and p-values

General statistical explanation: a confidence interval gives a range of estimates that are compatible with the data and the method used, under the assumptions of that method. It is not a guarantee that the true effect lies within the specific interval, and it does not measure the probability that a hypothesis is true. The interval is often more informative than a point estimate alone because it shows the precision of the estimate and which values remain compatible with the observed data.

A p-value summarizes how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the model assumptions were true. It is not the probability that the null hypothesis is true, nor a direct measure of clinical importance. The recalculated unadjusted p-value is 0.359, while the sponsor-reported p-value is 0.486. They are attached to different reported comparisons and should not be treated as duplicate values for one identical calculation.

What the composite means for analysis

The primary outcome classifies a participant as having an event if one or more of five components occurred. This rule makes the primary analysis a comparison of participants with any composite event, rather than a comparison of the number of components per participant. General statistical explanation: composites can increase the breadth of an endpoint, but the summary can obscure variation among components. A count of participants with any event does not reveal whether top-ups, catheter adjustments, or failures drove the result. The registry record does not report component-level counts for the primary endpoint.

The outcome is limited to the stated timeframe, from epidural placement to delivery, up to 32 hours. Statistical interpretation should therefore stay within that observation window. It does not establish what happened beyond the recorded period. The measure is reported as a participant count and has no dispersion statistic because it is not a continuous measurement.

Unadjusted re-calculation and reported analysis

The re-calculated estimates are described as simple, unadjusted calculations from the posted summary statistics. They are useful for presenting a common absolute comparison and for illustrating uncertainty from the arm counts. They do not replace the registry’s own analysis. The sponsor-reported primary result is the chi-squared risk ratio, and its values should be distinguished from the recalculated risk-difference result. The discrepancy indicator is false, but that does not make different effect measures identical or remove the need to identify which analysis is being described.

Adjustment for baseline variables, handling of missing outcomes, and the exact analysis population are not reported in the registry record. It is therefore not appropriate to claim that the reported or recalculated results are adjusted for participant characteristics, or to assert how missing data were treated. The registry does not report whether an interim analysis occurred or whether any multiplicity adjustment was prespecified.

Secondary comparisons

The posted secondary results also include binary participant counts, with comparisons reported by the registry as risk ratios and chi-squared analyses. Recalculated unadjusted risk differences and their intervals are available for the displayed secondary results. General statistical explanation: secondary endpoints can help describe other dimensions of a trial, but they do not automatically confirm or overturn the primary finding. Their interpretation depends on the endpoint definitions, precision, analysis plan, and whether multiple comparisons were considered. The registry record does not report a multiplicity procedure, so the secondary p-values should be regarded as exploratory rather than as a set of independently confirmatory tests.

These methods describe what the posted numbers can support, not the full statistical plan used by the investigators. The original sample-size justification and detailed protocol-level analytic choices are not reported in the registry record. Where those details are absent, the interpretation should remain tied to the observed counts, reported estimates, stated methods, and their uncertainty.

11. Confidence Intervals and Precision

The primary recalculated risk difference is -0.083, with a 95% confidence interval from -0.261 to 0.095. The interval is broad relative to the point estimate and spans zero. In practical terms, the posted data are compatible with a lower event frequency in DPE, little or no difference, or a higher event frequency in DPE under this absolute comparison. The estimate’s negative direction is not enough to resolve that uncertainty.

The sponsor-reported relative comparison is a risk ratio of 0.75, with a 95% confidence interval from 0.40 to 1.39. The interval spans the no-relative-difference value of 1 and includes values on either side. This is consistent with the lack of a clear difference in the sponsor’s reported p-value of 0.486. General statistical explanation: a 95% confidence interval reflects the range of effect estimates compatible with the data and method at the stated confidence level; a wider interval indicates less precision than a narrower one.

The re-calculated unadjusted p-value of 0.359 and the sponsor-reported p-value of 0.486 should be understood in the context of their respective analyses, rather than selected between as if they were the same statistic. The sponsor reports a chi-squared risk ratio, while the re-calculation reports an absolute risk difference. Both presentations leave uncertainty about the magnitude and direction of the underlying effect.

These intervals do not prove that the techniques are the same, and they do not prove a difference. The registry record does not report a prespecified equivalence or noninferiority margin, so the estimates cannot be used to declare equivalence. The sample available for the posted primary results is limited to the recorded arm denominators, and the enrollment entry is not fully reconciled with those denominators in the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size table and curve are planning illustrations based on the observed primary effect, not a record of the trial’s original design calculation. The displayed figures are participants per arm, not total participants. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The trial’s own original sample-size assumptions are not reported in the registry record.

For planning around 100% of the observed effect, the table gives 466 participants per arm for 80% power and 624 participants per arm for 90% power. For planning around 75% of the observed effect, it gives 847 participants per arm for 80% power and 1,133 participants per arm for 90% power. For planning around 50% of the observed effect, it gives 1,942 participants per arm for 80% power and 2,599 participants per arm for 90% power. The curve presents the planning relationship visually; it does not show additional observed trial results.

General statistical explanation: power is the chance, under specified assumptions and a particular true effect, of detecting that effect using the planned test at the chosen significance level. The 80% and 90% columns therefore describe alternative planning targets: the higher target requires more participants under the stated assumptions. Smaller effects are harder to distinguish from random variation, so planning to detect a smaller fraction of the observed effect requires more participants. These figures are not observed power for this completed trial; they are sample-size planning illustrations derived from its observed effect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.333; treatment proportion p₁ = 0.250; average p̄ = 0.292.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6428 = 1.2599.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6401 = 0.5387.
4. n = (1.2599 + 0.5387)² / (-0.0833)² = 465.8, rounded up to 466 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.333333333333333                          # control proportion
p1 <- 0.25                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(5068661)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 466 (80% power), 624 (90% power)
 75% of observed effect: n per arm = 847 (80% power), 1,133 (90% power)
 50% of observed effect: n per arm = 1,942 (80% power), 2,599 (90% power)
power.prop.test: 465.8 
Simulated power at n = 466 per arm: 0.803 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry’s own primary analysis reports a chi-squared comparison as a risk ratio of 0.75, with a 95% confidence interval from 0.40 to 1.39 and p = 0.486. This is the sponsor-reported inferential result and should be quoted as such. It expresses the comparison on a relative scale.

The re-calculation uses the posted arm counts to describe an unadjusted absolute risk difference of -0.083, with a 95% confidence interval from -0.261 to 0.095 and an unadjusted p-value of 0.359. This provides a different scale for understanding the comparison. The two p-values are not directly interchangeable because they accompany different effect measures and calculations. Both sets of results show uncertainty that includes no difference; neither should be selectively presented as a definitive conclusion.

The registry marks the discrepancy indicator as false. That status does not mean the relative and absolute estimates should match numerically: they use different measures. The sponsor’s analysis is the official posted analysis, while the re-calculation is an additional descriptive comparison derived from the published summary counts. The registry record does not provide enough detail to characterize every aspect of the sponsor’s analytic implementation, so the comparison should not be used to infer unreported modeling choices.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates more than one outcome or conducts several statistical comparisons. General statistical explanation: as the number of tests increases, the chance of at least one apparently notable result arising by chance can increase if each test is interpreted separately. Trial protocols may address this through a prespecified hierarchy, adjusted significance thresholds, or other procedures. The registry record lists nine outcome measures and nine analyses, but a multiplicity procedure or hierarchy is not reported in the registry record. The posted secondary results should consequently be read with caution and should not be treated as a collection of confirmatory tests.

The record describes randomization and quadruple masking, but it does not report the detailed allocation process, how masking was implemented, or which roles were masked. The randomization label indicates the recorded design feature; it is not enough to reconstruct concealment or implementation. The registry also does not report whether interim analyses occurred or whether stopping rules were used.

Missing-data handling is not reported in the registry record. The enrollment field lists 101, while the primary outcome denominators are 48 and 52. The record does not explain the difference. It also does not specify whether all randomized participants were included in the primary analysis, how any missing endpoint information was handled, or whether an intention-to-treat analysis was used. These details matter because the analyzed group and missing outcomes can affect interpretation of a randomized comparison.

The registry does not provide the full analysis plan, including any prespecified covariate adjustment, handling of protocol deviations, or sensitivity analyses. No particular method should be assumed. The posted primary results can be interpreted as reported, but the absence of those details limits assessment of whether all analyses followed a prespecified plan and how robust the findings are to alternative assumptions.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event entries report zero affected participants among 48 at risk in the CSE arm and zero among 52 at risk in the DPE arm. The record also reports zero deaths in each arm. These figures describe the serious-event and death counts recorded in the registry results; they do not show that no serious events could occur, nor do they establish that the techniques have identical safety profiles.

For other adverse events, the registry reports 40 of 48 participants affected in the CSE arm and 37 of 52 in the DPE arm. The record does not list serious adverse event terms, and no serious terms are reported in the posted data. The category of other adverse events should not be interpreted as a specific type or severity of event without further detail.

General statistical explanation: zero observed events do not establish zero underlying risk, particularly when the number of participants observed is limited. Safety comparisons also depend on the definitions, collection period, and completeness of reporting. The registry record does not give additional detail about those features, so the figures are best read as counts reported for the study rather than as a comprehensive safety assessment.

17. What the Result Does, and Does Not, Mean

The primary result describes the observed frequency of a composite block-quality event in the two randomized arms. The event was recorded for 16 of 48 participants in the CSE group and 13 of 52 in the DPE group. The estimated comparison points toward fewer composite events in DPE, but both the sponsor-reported and recalculated results are uncertain and do not establish a clear difference.

This result does not show that DPE is superior, nor does it establish that CSE and DPE are equivalent. The confidence intervals remain compatible with effects in either direction, and the registry record does not report an equivalence or noninferiority framework. A nonsignificant result is not proof of no effect; it can reflect imprecision as well as a genuinely small difference.

The endpoint represents any one or more of five components, not a direct measure of every aspect of analgesia or labor experience. Without separate counts for the components, the result cannot show whether the observed events involved top-ups, catheter adjustments, failed catheters, or the more serious failure scenarios described in the endpoint definition. The available outcome should not be generalized to unmeasured clinical outcomes.

The secondary measures add context but do not remove the uncertainty in the primary comparison. The registry lists several outcomes for which detailed results are not included in the data, and the record does not report a multiplicity plan. Those limitations make it important not to overinterpret selected secondary findings or treat their absence as evidence of no difference.

These are results from the completed trial as represented in the registry record. They do not, on their own, answer questions about other populations, settings, or outcomes. The record’s enrollment figure and primary outcome denominators also differ, without an explanation in the registry. Overall, the posted evidence supports a cautious description of the observed comparison, not a definitive conclusion about the relative performance of the two techniques.

18. Why This Trial Matters Statistically

This trial illustrates why a point estimate should be read alongside its confidence interval and the endpoint definition. The observed primary counts differ in direction from the null, and the re-calculated risk difference gives a concise absolute comparison. Yet its interval spans values on either side of no difference. Reporting only the direction of the point estimate would overstate what the data establish; reporting only a p-value would conceal the range of effects compatible with the data.

The registry also offers a useful contrast between relative and absolute effect measures. Its own analysis reports a risk ratio, while the additional re-calculation expresses an absolute risk difference. Both are legitimate ways to describe a comparison, but they answer different questions and should be named clearly. The distinction helps readers avoid treating estimates on different scales as conflicting versions of a single number.

The primary composite shows another statistical issue: combining multiple components can give a concise overall endpoint, while leaving uncertainty about which event types contribute to the result. A participant-level composite count is not equivalent to a detailed account of every component. Component-level reporting would be needed to make that distinction, and it is not reported in the registry record.

Finally, the sample-size illustrations show how planning requirements depend on the effect targeted and the desired power. They are not evidence that the completed study had a particular probability of detecting its observed result. Keeping planning calculations separate from trial outcomes is essential to avoid interpreting retrospective illustrations as trial design justification or as observed power.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this record constrain interpretation. First, enrollment is listed as 101, while the primary outcome denominators are 48 and 52. The registry record does not explain the difference, so the relationship between enrollment and the analyzed outcome group cannot be reconstructed. Missing-data handling and the analysis population are not reported.

Second, the primary endpoint is a composite, but component-specific event counts are not reported. The overall result therefore cannot show which of the five components contributed to the arm totals or whether the pattern differed across components. The registry also does not give details on the severity or clinical context of individual composite events.

Third, the registry reports a sponsor analysis as a risk ratio and the re-calculation as an absolute risk difference. These are different measures. The record does not provide a detailed statistical analysis plan to explain all analytic choices, including adjustment, missing-data methods, or sensitivity analyses. The discrepancy indicator is false, but that does not fill in details absent from the record.

Fourth, the multiplicity approach for the listed secondary outcomes is not reported. Several outcomes are registered, but detailed results are not available for every listed measure in the data. Consequently, secondary findings carry less confirmatory weight, and unreported results should not be inferred.

Finally, masking is recorded as quadruple, but the identities of masked parties and implementation details are not reported. The original sample-size rationale, interim analyses, and trial-specific planning assumptions are also not reported in the registry record. These omissions limit assessment of design rationale and conduct beyond the summary information shown.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Comparing Effectiveness of CSE Versus DPE for Labor Analgesia — NCT05068661.
• Registry record last updated 2024-11-06; status last verified 2024-10.
• Results first posted 2024-11-06.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

The registry describes a completed, randomized, quadruple-masked, phase 4 trial comparing combined spinal epidural with dural puncture epidural techniques for labor analgesia. Its primary outcome is the number of participants experiencing at least one of five block-quality components from epidural placement to delivery, up to 32 hours.

The primary counts are 16 of 48 for CSE and 13 of 52 for DPE. The registry-reported risk ratio is 0.75, with a 95% confidence interval from 0.40 to 1.39 and p = 0.486. The unadjusted re-calculated risk difference is -0.083, with a 95% confidence interval from -0.261 to 0.095 and p = 0.359. Both comparisons leave substantial uncertainty.

Secondary outcomes and adverse-event counts provide additional context, but the record does not report several details needed for a complete appraisal, including the original sample-size justification, missing-data methods, analysis populations, and multiplicity procedure. The posted results should therefore be read as a limited account of the observed trial data rather than a definitive resolution of the comparison.