LaPPS: Labor Podcast for Patient Satisfaction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for LaPPS: Labor Podcast for Patient Satisfaction (NCT04933708), a randomized na study. The primary outcome is Labor Agentry Scale.

2. Clinical Question

The clinical question is about a behavioral intervention and a patient-reported outcome after delivery. The Labor Agentry Scale score ranges from 10 to 70; higher scores are described in the registry as indicating more agentry, which the study considers better. Birth Satisfaction and the Edinburgh Postpartum Depression Scale are listed as secondary outcomes, but the registry record does not post their results in the registry record.

The posted primary outcome summaries are medians of 57 for the Labor Podcast Group and 54 for Usual Care. The reported inter-quartile bounds are 50 to 63 and 47 to 62, respectively. These descriptive summaries do not themselves establish whether a between-group difference is statistically distinguishable from chance, nor do they establish the size or precision of an adjusted treatment effect. A statistical comparison result is not reported in the registry record.

3. Trial Design

NCT04933708, titled “LaPPS: Labor Podcast for Patient Satisfaction,” is listed as a completed, randomized, single-masked, parallel-group trial sponsored by the University of Pennsylvania. The registry lists an enrollment of 201. The study dates are listed as starting 2021-07-01, with primary completion on 2022-07-01. The phase is recorded as NA.

Participants were assigned to a Labor Podcast Group or Usual Care. The intervention is classified as behavioral. The arm description says participants assigned to the podcast group received access to six HUP physician-created labor podcasts in addition to usual care during labor, delivery, and postpartum. The brief summary describes seven labor podcasts, so the number of podcasts is inconsistent within the registry record. The usual-care arm is described as receiving usual care during labor, delivery, and postpartum, with participants sent the LAS-10 and Birth Satisfaction surveys on postpartum day 2 by their stated preferred method, email or text message.

The primary outcome is the Labor Agentry Scale, assessed two days after delivery. The registry lists Birth Satisfaction and the Edinburgh Postpartum Depression Scale as secondary outcomes. Although the study is described as single-masked, who was masked is not reported in the registry record. Details of sequence generation, allocation concealment, stratification, and the practical implementation of masking are also not reported in the registry record. A sample-size justification and a fuller statistical analysis plan are not reported in the registry record.

The registry lists an overall enrollment of 201, while the posted primary outcome summaries list 78 participants in the Labor Podcast Group and 75 in Usual Care. The reasons that outcome counts differ from the enrollment figure are not reported in the registry record. These counts should therefore be read as the numbers associated with the posted outcome summaries, not as a complete account of participant flow.

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.

6. Primary Endpoint

The registry lists the primary outcome as Labor Agentry Scale, measured over 2 days after delivery.

The primary endpoint is the Labor Agentry Scale score measured two days after delivery. The registry describes the scale as ranging from 10 to 70 and says that higher scores indicate more agentry, which the study considers better. The scale is intended to capture a participant’s reported sense of agency in labor. It therefore addresses an experience of care, rather than a clinical event or a measure of labor duration.

The registry states that participants complete the scale after delivery and that scores are compared between groups. A patient-reported measure can be useful when the research question concerns how participants experience labor: it records that experience directly rather than relying only on clinical observations. That makes the endpoint relevant to the study’s interest in a podcast intervention and patient satisfaction, although the Labor Agentry Scale and Birth Satisfaction are distinct outcomes.

The posted summaries use medians and inter-quartile ranges. The median describes the middle of the observed score distribution, while the inter-quartile range describes the spread of the central portion of that distribution. The Labor Podcast Group has a median score of 57, with reported bounds of 50 and 63. Usual Care has a median of 54, with reported bounds of 47 and 62. Those summaries describe the observed groups; they do not supply an estimate of uncertainty for a between-group effect. The registry record does not report a statistical comparison for this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is reported as a median with an inter-quartile range, rather than as a mean with a standard deviation. A median is the midpoint of an ordered set of observations: half of the observed values fall at or below it and half at or above it, allowing for ties. The inter-quartile range describes the central spread of observations. In this record, the Labor Podcast Group median is 57 with reported bounds of 50 and 63; the Usual Care median is 54 with reported bounds of 47 and 62.

What do medians and inter-quartile ranges describe?

These summaries describe the location and spread of scores within each group. They are useful when the distribution may be skewed or when a small number of unusually high or low values could pull a mean. They do not show every participant’s score, and they do not directly estimate the uncertainty of a between-group difference. Overlap between the reported inter-quartile bounds is not a formal test of whether the groups differ. A comparison needs a specified statistical procedure and a measure of uncertainty appropriate to the design and data.

What is needed to interpret a group comparison?

For a randomized parallel-group study, an inferential analysis would ordinarily report a contrast between groups and explain its uncertainty, for example with a confidence interval and, where used, a p-value. A confidence interval expresses the range of effect estimates compatible with the data under the assumptions of the analysis; it is not a range containing a fixed proportion of individual participant scores. The registry record does not report a confidence interval or p-value for the primary outcome, nor does it describe a statistical model or test. Thus, no such comparison can be interpreted from the posted summaries.

General statistical principle: the choice of comparison method depends on the outcome distribution, the estimand of interest, the study design, and the analysis plan. For a score summarized by medians, a method targeting a difference in medians is not interchangeable with a method targeting a difference in means or a broader distributional contrast. The registry does not say which contrast was planned. It also does not report whether any adjustment for baseline factors was intended or conducted. The planned estimand and analysis method are therefore not reported in the registry record.

What does randomization contribute?

Random assignment is intended to make the treatment groups comparable, on average, with respect to measured and unmeasured characteristics at allocation. In general, this supports causal interpretation of a between-group contrast when follow-up, outcome measurement, and analysis preserve the randomized comparison. Randomization does not guarantee that the realized groups are identical, and it does not remove the need to account for missing outcomes or deviations from the assigned intervention. The registry identifies the allocation as randomized but does not report the sequence-generation method, concealment procedures, or analysis population.

The registry labels the design single-masked, but does not report who was masked. Since the intervention involves access to podcasts, it is important for interpretation to know whether participants, outcome assessors, or analysts were masked; those details are not reported in the registry record. The scale is described as completed by participants after delivery, but the record does not further detail how survey administration or masking was handled.

What can planning illustrations tell readers?

General statistical principle: sample-size calculations are planning exercises, not evidence that a trial had a particular probability of finding a result after it was completed. The planning illustrations associated with this analysis use the observed effect as a reference, assume a two-sided significance level of 0.05, equal allocation, and a normal approximation, and consider effects defined as fractions of the observed effect. They are not the trial’s original design justification, which is not reported in the registry record. Any such illustrations depend on their assumptions and should not be described as observed power. The effect fractions and resulting sample-size values are not reported in the registry record details used for this interpretation, so no specific planning number is stated.

General statistical principle: over-dispersion occurs when variability in data exceeds what a chosen statistical model assumes. If it is ignored, standard errors can be too small and uncertainty can be understated. Whether over-dispersion is relevant depends on the outcome and model. The registry record does not report a model for this endpoint or evidence about over-dispersion, so no model-specific conclusion can be made.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures in total: the primary Labor Agentry Scale and the secondary outcomes Birth Satisfaction and the Edinburgh Postpartum Depression Scale. When several outcomes or several statistical comparisons are examined, multiplicity can increase the chance of at least one apparently notable finding by chance. General statistical practice may address this by prespecifying a primary outcome, limiting confirmatory comparisons, or adjusting inference across a family of tests. The registry record does not report a multiplicity strategy, a hierarchy among the secondary outcomes, or results for those secondary outcomes. It is therefore not possible to determine how multiplicity was handled.

Missing-data methods and the amount or pattern of missing outcome data are not reported in the registry record. The record lists 201 participants enrolled, while the primary outcome summaries list 78 in the Labor Podcast Group and 75 in Usual Care. It does not explain the relationship between enrollment and the outcome counts, or describe the number of participants randomized, followed, or included in each analysis. Reasons for missing scores, if any, and methods for handling them are not reported in the registry record.

Analysis populations are also not reported in the registry record. In general, an intention-to-treat analysis compares participants according to randomized assignment, while other analysis populations may require adherence or outcome availability criteria. The record does not identify which population generated the posted primary summaries, whether participants were analyzed as randomized, or how any departures from assignment were handled. No imputation or sensitivity analysis is reported. Without these details, the possible influence of missing data and analysis choices cannot be evaluated from the posted summaries.

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

The posted primary outcome data describe Labor Agentry Scale scores two days after delivery in the two randomized groups. The median is 57 in the Labor Podcast Group and 54 in Usual Care. The reported inter-quartile bounds are 50 to 63 and 47 to 62, respectively. These values communicate the central location and spread of the observed scores; they do not provide a formal estimate of the difference between groups or the uncertainty around that difference.

The registry record does not report an inferential comparison for the primary endpoint. It therefore does not establish whether the observed descriptive difference is compatible with chance variation under a specified statistical model, nor does it quantify how precisely any treatment effect has been estimated. No conclusion about statistical significance or the magnitude of an underlying effect follows from the medians alone.

The score is a patient-reported measure of labor agentry, not a direct measure of every aspect of patient satisfaction. Birth Satisfaction and the Edinburgh Postpartum Depression Scale are listed as secondary outcomes, but their results are not reported in the registry record. The posted primary endpoint should not be used as a substitute for those distinct outcomes.

These data also do not establish that the intervention does or does not change clinical outcomes, postpartum depression, or safety. The registry lists zero counts for the posted adverse-event categories in both arms, but the record does not provide further event definitions or a detailed safety analysis. Nor does it provide information on missing outcomes, adherence, or which participants were included in the primary summaries. The evidence described is therefore limited to the reported outcome summaries and the registry entries recorded about the trial design.

12. Why This Trial Matters Statistically

This trial is statistically interesting because it evaluates a behavioral intervention using a patient-reported endpoint after delivery. Such endpoints focus on participants’ experiences, which may not be captured by clinical events alone. The Labor Agentry Scale is specified as the primary outcome, while Birth Satisfaction and the Edinburgh Postpartum Depression Scale are listed as secondary outcomes. Keeping these measures conceptually distinct matters: each addresses a different aspect of the postpartum experience.

The randomized, parallel-group design is relevant to how a treatment contrast could be interpreted. In general, randomization can support a fair comparison, but transparent reporting of the analysis population, missing data, outcome summaries, and uncertainty is needed to judge the strength and precision of the evidence. Here, the registry reports group medians and inter-quartile bounds, but no statistical comparison result. That makes the difference between descriptive reporting and inferential evidence especially important.

The registry also contains an internal difference in the described intervention dose: its brief summary refers to seven labor podcasts, while the arm description refers to six HUP physician-created podcasts. This ambiguity is material when describing what participants were assigned to receive. The registry record does not clarify the discrepancy.

Finally, sample-size planning illustrations should be distinguished from the original trial design rationale and from results observed after the trial. The planning assumptions associated with the illustrations are not a substitute for a registry-reported sample-size justification, which is not reported in the registry record. Together, these reporting features show why readers need both clear intervention descriptions and complete statistical results to interpret a randomized trial responsibly.

13. 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 for interpreting this specific trial is that the registry posts descriptive summaries for the primary endpoint but no inferential comparison. There is no reported estimate of a between-group effect with an uncertainty interval, and no p-value or model description. The posted medians and inter-quartile bounds cannot answer how precise a group contrast is.

The available participant counts are also incomplete for understanding the analysis. The registry lists enrollment of 201, while the primary outcome summaries list 78 participants in the Labor Podcast Group and 75 in Usual Care. Participant flow, the number randomized to each group, and explanations for the outcome counts are not reported in the registry record. Missing-data amounts, reasons, and handling methods are not reported either.

The intervention description is inconsistent: the brief summary says seven podcasts, whereas the arm description says six HUP physician-created podcasts. The registry does not explain which description reflects the intervention actually delivered. It also does not identify who was masked despite labeling the trial single-masked, and it does not report adherence, use of the podcasts, or intervention fidelity.

The record does not report the statistical analysis plan, sample-size justification, analysis population, multiplicity approach, or whether any covariate adjustment was planned. The secondary outcomes are named but their results are not reported in the registry record. Finally, the adverse-event entries are limited to the posted categories and counts; additional event definitions and detailed safety analyses are not reported. These gaps restrict assessment of precision, potential bias, and the completeness of the reported outcomes.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: LaPPS: Labor Podcast for Patient Satisfaction — NCT04933708.
• Registry record last updated 2025-04-24; status last verified 2025-04.
• Results first posted 2024-10-16.
• 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.

17. Record Summary

NCT04933708 is a completed, randomized, single-masked, parallel-group behavioral trial sponsored by the University of Pennsylvania. The registry lists enrollment of 201 and study dates from 2021-07-01 to primary completion on 2022-07-01. Nulliparous women were assigned to labor podcasts plus usual care or usual care. The record differs on intervention dose: the brief summary says seven podcasts, while the arm description says six HUP physician-created podcasts.

The primary outcome is the Labor Agentry Scale score two days after delivery. The Labor Podcast Group has a median of 57, with reported inter-quartile bounds of 50 to 63; Usual Care has a median of 54, with bounds of 47 to 62. The registry record does not report a statistical comparison, confidence interval, or p-value. Birth Satisfaction and the Edinburgh Postpartum Depression Scale are listed as secondary outcomes, but their results are not reported in the registry record. Analysis populations, missing-data methods, and the sample-size justification are also not reported in the registry record.