Designed Protocol of Care for Postpartum Perineal Trauma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Designed Protocol of Care for Postpartum Perineal Trauma (NCT05268276), a randomized na study. The primary outcome is Severity of Postpartum Perineal Pain.

2. Clinical Question

The registry also describes hypotheses concerning perineal healing, infection, and difficulty performing functional activity. These are distinct outcomes from pain severity and would require their own outcome definitions and comparisons to interpret. The record does not report numerical results for these outcomes. Therefore, the stated research question and outcome schedule describe what the trial set out to examine, but they do not establish what the trial observed.

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. Its listed enrollment is 100. The record is marked completed, and gives a study start date of 2021-10-10 and a primary completion date of 2022-03-15. These record details describe the registered study; they do not establish how many participants were ultimately analyzed or whether every planned assessment was completed.

Participants were assigned to a study group receiving the designed protocol or a control group receiving routine hospital care. Random allocation can, in general, reduce systematic differences between groups at the point of assignment. It does not guarantee that the groups are identical, especially in a trial of this size, and it does not eliminate bias from outcome measurement, missing follow-up, or analysis choices.

Masking is listed as none. In general, when participants and care providers know which care is being received, expectations and behavior can influence outcomes or their assessment. This consideration is relevant to a self-reported pain scale. The registry does not report whether outcome assessors were masked, how treatment assignment was implemented, or whether allocation concealment was used.

The primary outcome is a continuous pain score measured repeatedly from one hour after delivery through day 7 after delivery. Such repeated assessments can describe how scores change over time, but interpretation depends on the planned statistical comparison: for example, a comparison at each time point is not the same estimand as a comparison of an overall trajectory. The statistical plan and the analysis population are not reported in the registry record.

The registry lists 4 outcome measures and 0 analyses. It does not report group means, standard deviations, confidence intervals, p-values, or a primary-outcome treatment effect. Thus the available record gives the design and intended measurements, but not an analyzable account of the trial’s primary result.

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.

Before assignment: no participants were excluded for the study after enrollment and before assignment to study or control group

Overall Study

Analysis population for the primary outcome, as defined in the registry: severity of postpartum perineal pain

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.

6. Primary Endpoint

The registry lists the primary outcome as Severity of Postpartum Perineal Pain, measured over one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery.

The primary endpoint is severity of postpartum perineal pain, described as a score on a scale and summarized in the registry as a mean with standard deviation. The instrument is the Visual Analogue Scale for pain intensity, described as a self-reported 10 cm horizontal line representing a participant’s subjective pain intensity. The record also describes a 0–10-point numerical scale with categories for no pain, mild pain, moderate pain, and severe pain. The category boundaries are described in the registry record.

Pain intensity is relevant to the stated question because the intervention is intended to affect postpartum perineal trauma outcomes, including pain. A continuous score can preserve gradations in reported intensity rather than reducing every assessment to a category. In general, the mean describes the group’s average score, while the standard deviation describes variation in scores among participants. Neither statistic alone communicates the precision of a between-group effect; that ordinarily requires an estimate of the difference and an uncertainty measure such as a confidence interval.

The outcome is scheduled at one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, and day 7 after delivery. Repeated measurements can help characterize pain over time, but they also raise a question about which comparison is primary. The registry record does not report a numerical score at any listed assessment, the treatment-effect estimate, or the analysis used to combine or compare repeated scores.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The registry specifies that the primary pain outcome is a continuous measure summarized by a mean and standard deviation. In general, a mean is the arithmetic average of the recorded scores and gives a central summary for a group. The standard deviation describes how dispersed individual scores are around that average. It is not the same as the uncertainty in the estimated mean, and it is not itself a treatment-effect estimate. A comparison of group means would need to be reported separately, with an uncertainty measure that reflects the design and analysis.

The registry does not report the means or standard deviations for either group. It also does not report a difference in means, confidence interval, or p-value. Thus there is no numerical comparison to interpret. A description of the outcome scale and summary statistic is not a substitute for results.

Why does the assessment schedule matter?

Pain is assessed repeatedly, from one hour after delivery through day 7 after delivery, at the times listed in the registry. Repeated scores from the same participant are generally related rather than independent. In general, analyses of repeated measures account for that within-participant relationship. Ignoring it can make uncertainty estimates inappropriate. The particular method used for this trial is not reported in the registry record.

There is also a choice of estimand: a statistical analysis could focus on a specified time point, compare average scores across a period, or estimate differences in the pattern of scores over time. These answer different questions. The registry does not report which of these was prespecified as the principal comparison, or whether each listed time point was intended to have a separate test. A reader should not treat the list of assessment times as evidence that every time point was analyzed or that a particular time point was selected after seeing the results.

What does randomization contribute?

In general, random assignment aims to make treatment groups comparable with respect to both measured and unmeasured characteristics at the time of assignment. It supports a causal interpretation when allocation is implemented as intended and when the analysis respects the randomized design. Randomization does not ensure balance in every characteristic in a particular trial. It also cannot by itself address missing outcomes, deviations from assigned care, or choices made after outcome data are examined.

The record identifies randomized allocation and a parallel model, but does not report the allocation procedure, concealment, baseline characteristics, or analysis population. It therefore does not allow an assessment of how assignment was implemented or whether the reported analysis, if any, preserved the benefits of randomization.

How should uncertainty and statistical significance be read?

In general, a confidence interval gives a range of effect values reasonably compatible with the observed data under the model and assumptions used. It is more informative about precision than a p-value alone. A p-value addresses how surprising data at least as extreme as those observed would be under a specified null model; it does not give the probability that the null hypothesis is true, and it does not measure the size or importance of an effect.

No confidence interval or p-value for the primary outcome is reported in the registry record. The record does state that a sample-size planning illustration used a two-sided significance level of 0.05, equal allocation, and a normal approximation, with an effect defined as a stated fraction of the observed effect. Those are planning assumptions, not evidence of an observed result or of the trial’s original design justification. The illustration’s resulting sample-size values are not reported in the registry record. Such planning values must not be interpreted as observed power or as proof that the trial could detect a particular effect.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model expects. It matters most in models where variance is tied to the mean, such as some analyses of counts or binary outcomes. If over-dispersion is not accommodated, uncertainty can be understated and inferential conclusions can be too confident. The primary endpoint is described as a continuous score, and the registry does not report an analysis model or evidence of over-dispersion. This general issue should not be mistaken for a finding about this trial.

What can be inferred from the registered methods?

The registered information establishes that the intended primary outcome was self-reported pain severity and that the investigators planned to summarize it as a mean and standard deviation at repeated assessments. It does not specify the statistical model, covariate adjustment, handling of missing scores, multiplicity procedure, or analysis population. These details are not reported in the registry record. Without outcome data and analysis details, no recalculated effect estimate or independent check of the sponsor’s analysis is possible. The registry also does not report a sponsor analysis to compare with a recalculation.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, time points, or statistical comparisons are examined. In general, the more tests performed, the greater the chance of at least one apparently notable result arising by chance if no adjustment or prespecified hierarchy is used. Repeated pain assessments create a potential multiplicity issue if each time point is tested separately. The listed secondary outcomes—postpartum perineal trauma infection and difficulty performing functional activity—also represent additional questions beyond the primary pain endpoint.

The registry record does not report a multiplicity strategy, a hierarchy among endpoints, or which comparison was designated as the primary statistical test. It lists 4 outcome measures and 0 analyses. Therefore, it is not possible to determine whether multiplicity was addressed, which outcomes were analyzed, or whether any reported result would have been selected from multiple comparisons.

Missing data are another important issue for repeated assessments. In general, missed pain scores can reduce the information available and can bias a comparison if the likelihood of missingness is related to a participant’s condition or outcome. Statistical methods make different assumptions about missingness; those assumptions and any sensitivity analyses matter to interpretation. The registry does not report the number of missing scores, reasons for missingness, imputation procedures, or sensitivity analyses.

The analysis population is also not reported in the registry record. For example, the record does not say whether analyses followed randomized assignment regardless of care received, or whether another population was used. These choices can affect the question answered by an analysis. The listed enrollment of 100 does not establish how many participants contributed to each outcome analysis.

11. 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.

The registry’s adverse-event record lists 50 participants at risk in the Study Group and 50 in the Control Group for serious events, with 0 affected in each group. For other events, it likewise lists 50 at risk in each group and 0 affected in each group. Deaths are recorded as 0 in both groups, and no top serious-event terms are listed.

These entries describe what the registry reports; they do not show that all possible harms were systematically assessed or that no events occurred outside the record’s reporting framework. The record does not provide event definitions, the observation period for safety, event-specific follow-up completeness, or details of how adverse events were collected. It also does not explain whether the figures reflect the full trial population or a safety-analysis population.

In general, zero events in a study do not establish that an event is impossible or that risk is absent. The precision of a safety estimate depends on the amount of exposure, event ascertainment, follow-up, and the outcome’s frequency. The reported at-risk counts and zero affected counts should therefore be read as registry entries, not as proof of safety or as a comparison demonstrating an absence of risk.

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

The trial record identifies a clinically focused question: whether a designed care protocol is associated with different postpartum perineal pain scores than routine hospital care among women with vaginal delivery and perineal trauma. It also identifies an intended assessment schedule and additional outcomes related to healing, infection, and functional activity. These details clarify the purpose and structure of the study.

What the record does not establish is the result. It contains no reported group pain scores, standard deviations, effect estimate, confidence interval, or p-value. It does not report numerical results for healing, infection, or functional activity. The intended hypotheses cannot be treated as observations, and a completed status cannot be taken as evidence that the hypothesized differences were found.

In general, a statistically detectable difference and a clinically important difference are not identical concepts. Statistical interpretation concerns how compatible the data are with a specified model; clinical importance concerns the size and relevance of the effect in context. Both require outcome estimates, and precision requires uncertainty information. Because neither is reported for the primary endpoint, the size and practical meaning of any between-group difference cannot be assessed from this record.

The absence of reported results also prevents assessment of consistency across the repeated pain assessments. A single comparison, a trend over time, and an average across assessments could lead to different interpretations. The analysis approach and results are not reported in the registry record, so none of these patterns can be inferred.

The appropriate conclusion is limited: the registry describes a randomized parallel-group study and its intended outcomes, but it does not provide the numerical findings needed to determine what the trial observed. This is not evidence that the protocol did or did not change pain, healing, infection, or functional outcomes.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between a registered research question and a reported result. A clear intervention contrast and a prespecified outcome schedule tell readers what investigators intended to study. They do not tell readers whether outcome data were obtained, how those data were analyzed, or what the comparison showed.

Repeated pain measurement illustrates why endpoint definition matters. Scores at one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, and day 7 after delivery could support questions about individual time points or change over time. Those approaches are not interchangeable. A prespecified analysis helps distinguish the central question from additional exploratory comparisons, while appropriate handling of correlation and missing scores supports valid uncertainty estimates.

The record also illustrates why transparent reporting should include effect estimates and precision, not just a trial status or a list of intended outcomes. Group summaries alone would describe scores, but a between-group estimate with an uncertainty interval would be needed to evaluate the comparative effect. Analysis populations, missingness, and methods for multiple outcomes would further clarify how the result should be interpreted.

Here, the registry lists 4 outcome measures and 0 analyses, and it does not report the primary endpoint’s numerical results. That gap prevents readers from assessing effect magnitude, precision, or consistency across assessment times. The statistical importance of the trial record is therefore chiefly methodological: design information is useful, but without outcome reporting it cannot answer the stated comparative question.

14. 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.

The main limitation of the available record is the absence of numerical results for the primary endpoint. No group means, standard deviations, treatment-effect estimate, confidence interval, or p-value are reported. The registry also does not report numerical results for the other listed outcomes, so the intended hypotheses cannot be evaluated from this record.

Important design and analysis details are not reported in the registry record. These include eligibility criteria beyond the broad population description, the randomization procedure, allocation concealment, baseline characteristics, the definition of routine hospital care, and whether participants and outcome assessors knew treatment assignment. The record lists no masking, which is relevant because the primary outcome is self-reported, but it does not clarify assessor procedures.

For the repeated pain scores, the statistical model, primary comparison, and approach to within-participant correlation are not reported. The handling of missing assessments, deviations from assigned care, and the analysis population are also not reported. Without these details, readers cannot assess the assumptions behind a treatment-effect estimate—even if one were available elsewhere in a complete report.

The registry lists enrollment of 100, but it does not establish how many participants completed each assessment or contributed to each analysis. Its planning assumptions do not replace a reported sample-size justification or analysis plan, and resulting planning illustration values are not reported in the registry record. Safety interpretation is also constrained by the absence of event definitions and collection details. These limitations restrict interpretation to the registered design and intended outcomes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Designed Protocol of Care for Postpartum Perineal Trauma — NCT05268276.
• Registry record last updated 2025-03-19; status last verified 2025-03.
• Results first posted 2024-12-27.
• 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.

18. Record Summary

The record describes a completed randomized, parallel-group trial with no masking and listed enrollment of 100. The study compares a designed protocol that includes perineal ice-gel pad application, pelvic floor exercises, and perineal warm compresses with routine hospital care. Its primary outcome is postpartum perineal pain severity measured with a Visual Analogue Scale and summarized as a mean with standard deviation.

Pain assessments are planned from one hour after delivery through day 7 after delivery. The registry also lists perineal trauma infection and difficulty performing functional activity as secondary outcomes. It records 4 outcome measures and 0 analyses. Numerical results for pain and the other outcomes, along with the statistical analysis details needed to interpret them, are not reported in the registry record.