Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery (NCT02533167), a na na study. The primary outcome is Maternal Evoked Pain Scores.

2. Clinical Question

Maternal satisfaction and narcotic usage are named in the study title, and the brief description mentions assessment of pain and maternal satisfaction on post-delivery day 1. However, the registry record does not provide their numerical results or define their analysis in the available primary outcome entry. The clinical question can therefore be described as an evaluation of feasibility and maternal outcomes in a single group, not as a comparative estimate of the effect of skin-to-skin contact.

3. Trial Design

The registry lists NCT02533167 as completed, with Wake Forest University Health Sciences as sponsor. The recorded enrollment is 70. The recorded study dates are 2015-07 for the start and 2015-12 for primary completion. The phase is listed as NA.

The design is single group, with allocation listed as NA and masking listed as none. The intervention is skin-to-skin contact, described as being initiated on all consented cesarean sections while in the operating room. Because the registry does not identify a separate control arm, this is not a randomized comparison and does not support a direct treatment-versus-control estimate from the design information recorded.

The brief description concerns scheduled or non-emergent cesarean sections, receipt of the standard spinal anesthetic, and newborn assessment after delivery. Contact was to begin once Apgar scores and the newborn assessment were completed, with a goal of at least 60 minutes. The description allows for interruption during transfer from the operating room table to the stretcher. It says participants were to be seen on post-delivery day 1 for pain and maternal satisfaction assessments.

The registry does not report whether the planned contact duration was achieved for each participant, how many participants met the eligibility description, or how many completed each assessment. It also does not report a detailed protocol or an analysis plan. Those omissions limit what can be inferred about adherence, follow-up, and the population represented by any outcome summaries.

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 Maternal Evoked Pain Scores, measured over up to 24 hours.

The primary endpoint is maternal evoked pain, described as a continuous score measured with a 100 mm sliding visual analogue scale. Its anchors are 0 for no pain and 100 for the most severe pain ever. The registry gives the timeframe as up to 24 hours and identifies the summary measure as a mean with standard deviation.

A continuous pain scale can represent differences in reported symptom intensity across a range rather than reducing responses to a simple yes-or-no category. A mean describes the central value of scores in the analyzed group, while a standard deviation describes how dispersed individual scores are around that mean. These are general interpretations of the stated summary measures; the registry record does not report the actual mean or standard deviation for this endpoint.

The endpoint is relevant to the stated study focus on pain after cesarean delivery, and the brief description says pain was assessed on post-delivery day 1. The exact assessment schedule, the handling of multiple pain assessments, and the particular evoked-pain procedure are not reported in the registry record. Without the observed score and a defined comparator, the endpoint cannot establish how pain in this group differed from pain under another care approach.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the stated summary measure mean?

The primary endpoint is continuous and is summarized by a mean and standard deviation. General explanation: the mean is the arithmetic average of the observed scores included in an analysis. The standard deviation describes how much individual scores vary around that average. These measures answer different questions: one describes the group’s central score and the other describes the spread of its scores. They do not, on their own, show whether an intervention caused a change or whether an estimate is precise.

The endpoint uses a 100 mm sliding visual analogue scale, anchored at 0 for no pain and 100 for the most severe pain ever. The scale’s endpoints give the score a defined direction and interpretation. A mean score would need to be read in the context of the scale, the assessment timing, and the population whose scores were included. The registry describes the timeframe as up to 24 hours, but does not report the actual mean, standard deviation, or analysis details for the endpoint.

What would a confidence interval add?

General explanation: a confidence interval communicates uncertainty around an estimated quantity. It is influenced by the observed data and the statistical method used. It is not a guarantee that the true value lies within the interval, and it does not correct for limitations such as selection, missing data, or lack of a comparator. No confidence interval for maternal evoked pain is reported in the registry record, so the estimate’s precision cannot be evaluated from the recorded results.

What does a single-group design allow?

The registry identifies a single-group model, allocation NA, and no masking. The recorded intervention is skin-to-skin contact initiated in the operating room. General explanation: a single-group study can describe outcomes observed in the group receiving the intervention, if those outcomes are reported. Without a concurrent control group, however, a difference attributable to the intervention cannot be separated from other possible influences, such as the participants’ characteristics, the delivery context, or changes over time. These are general design considerations, not claims about what occurred in this study.

The registry’s own caution says the arms are not a like-for-like control comparison. No between-group effect estimate should therefore be inferred from this record. The design information also does not state whether a within-person baseline comparison was planned or performed. Such a plan is not reported in the registry record.

How should planning illustrations be understood?

The registry describes sample-size assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says the effect to detect is a stated fraction of the observed effect, and that the illustration is computed from the observed effect rather than being the trial’s own design. These are planning assumptions, not evidence that the completed study enrolled those two arms or used that design.

The registry record does not report the observed effect needed to interpret such planning illustrations, and it does not report a sample-size justification for this single-group study. General explanation: a planning illustration estimates the sample size needed under its assumptions to detect a chosen effect with a chosen power. It is not a measure of the study’s observed power, and it cannot substitute for the actual outcome estimate and its uncertainty. The record’s description of equal allocation between two arms should not be mistaken for the trial design, which is listed as single group.

What can the listed analysis count tell us?

The registry lists zero analyses despite listing six outcome measures. That establishes that analysis entries are not present in the registry record; it does not establish that no analyses were conducted outside the registry. The primary endpoint’s mean and standard deviation are not reported. The registry also does not name statistical tests, adjustment variables, a model specification, an interim analysis plan, or a method for handling repeated measurements. These details cannot be reconstructed from the endpoint label or the study description.

General explanation: statistical methods should be interpreted alongside the outcome definition, participants included, and missing-data approach. A test result without that context can be difficult to assess; an outcome label alone does not establish which test was used. Here, the registered design and endpoint description permit a limited account of what was intended, but the lack of numerical outcome results and analysis details prevents a fuller statistical interpretation.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Skin to Skin")
n   <- c(55)
m   <- c(43.55)
sp  <- c(25.34)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Skin to Skin  55  43.550  25.340  36.700  50.400

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, but identifies only maternal evoked pain as the primary endpoint in the recorded outcome information. The other outcome measures and their numerical results are not reported in the registry record. The registry lists zero analyses. It does not report whether outcomes were tested, whether a hierarchy among secondary outcomes was specified, or whether any adjustment for multiple testing was planned or used.

General explanation: when multiple outcomes or repeated tests are examined, the chance of obtaining a result that appears notable by chance can increase. A prespecified primary endpoint and a transparent analysis plan help readers understand which findings were central and how secondary findings should be interpreted. Whether any multiplicity strategy was used in this study is not reported in the registry record.

The record does not state how many participants contributed to the primary endpoint or to the other outcomes. Although enrollment is listed as 70, the registry does not report an endpoint-specific analysis population or completion count. It also does not report whether missing observations occurred, why any measurements might be missing, or how missing values were handled. Imputation, complete-case analysis, and other missing-data procedures are not reported.

The registry does not define an intention-to-treat, per-protocol, or other analysis population. It is therefore not possible to determine which participants’ data were included in any endpoint estimate. Those omissions matter because the analyzed group and the handling of missing measurements can affect the interpretation of a summary. No assumption about either can be made from the registry record.

12. 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 safety entry lists one group titled Skin to Skin. It reports 55 at risk, 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. No top serious adverse event terms are listed.

These are counts recorded for the group and risk set in the safety entry. They do not establish that no adverse events were possible, and they do not show the comparative safety of skin-to-skin contact against another approach. There is no separate control group identified in the design. The registry record does not explain why the safety count at risk is 55 when enrollment is listed as 70, or whether the safety group and enrollment count refer to different analysis populations.

General explanation: a count of zero means no events of that type were recorded for the stated group and risk set in the registry entry. It should not be interpreted as proof of zero risk. The record does not report additional detail about event definitions, the safety-monitoring period, or how adverse events were collected. Thus, the safety entry supports only a description of the recorded counts, not a broader conclusion about comparative safety or all possible harms.

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

The record documents a completed, single-group study of skin-to-skin contact initiated in the operating room after cesarean delivery. It describes an intended approach, a primary endpoint of maternal evoked pain, and safety counts for the Skin to Skin group. It does not report the numerical primary endpoint result. As a result, the direction, size, and precision of the group’s pain scores cannot be assessed from the registry record.

The study design also lacks a separate control group in the registry information. Any observed outcome in the intervention group would be descriptive unless supported by a suitable comparison elsewhere. A single-group result cannot, on its own, distinguish the intervention’s contribution from other factors affecting pain or satisfaction. The record does not provide a causal effect estimate.

The title names maternal satisfaction and narcotic usage, but their numerical results are not reported in the registry record. The brief description says pain and maternal satisfaction were assessed on post-delivery day 1; it does not give their results. Nor does the available primary outcome entry provide a narcotic-usage result. Their inclusion in the study title should not be taken as evidence of a particular finding.

The safety entry records no serious adverse events, other adverse events, or deaths among the 55 listed at risk. These counts describe the registry entry, not comparative risk, and they do not explain the relation between the safety group and the enrollment count of 70.

Overall, the registry information supports a description of the study’s design and intended assessment, but not a conclusion about whether pain, satisfaction, or narcotic usage differed because of the intervention. The absence of reported numerical outcomes and analysis details is central to interpreting what the record can establish.

14. Why This Trial Matters Statistically

This trial is statistically notable because its stated clinical aim is paired with a single-group design. Such a design can document how an intervention was implemented and describe outcomes in the group studied, but it does not provide a like-for-like control comparison. The registry itself cautions that the arms are not a like-for-like control comparison. This distinction is important when a study title names an intervention and outcomes: an association or description should not be confused with an estimate of causal effect.

The primary endpoint is a continuous score with a defined scale and anchors. Continuous outcomes can preserve more gradation than a simple event count, but interpreting them requires the actual distribution or at least the reported summary, the number of participants analyzed, and the assessment timing. The registry gives the measure and its summary type but not the numerical result, so readers cannot assess its central value or variability.

The record also illustrates why enrollment, analysis populations, and safety risk sets should not be treated as interchangeable. Enrollment is listed as 70, while the safety group lists 55 at risk. The registry does not explain the relationship between those figures, and it does not report the endpoint-specific sample size. This limits assessment of follow-up and completeness.

Finally, the record lists six outcome measures but zero analyses. Without outcome results or a statistical analysis plan, readers cannot evaluate multiplicity handling, missing-data methods, or the rationale for the analyses. These gaps do not erase the study’s descriptive value, but they narrow the conclusions that can be supported from the registry information.

15. 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 interpretation is that the registry record does not report the numerical result for the primary endpoint. It identifies maternal evoked pain, a mean with standard deviation, and a timeframe of up to 24 hours, but supplies no observed mean, standard deviation, confidence interval, or test result. The direction and precision of the endpoint therefore cannot be evaluated.

The single-group design is a further limitation for causal interpretation. Allocation is listed as NA, masking as none, and the model as single group. A separate comparator is not identified, so the recorded design cannot distinguish an intervention-related effect from other explanations for outcomes. The registry cautions that the arms are not a like-for-like control comparison.

The record does not describe the analysis population, endpoint-specific participant counts, completion of assessments, or missing-data methods. Although enrollment is listed as 70, the safety entry lists 55 at risk, and the reason for the difference is not reported. It is not possible to determine from the registry how many participants contributed to the primary endpoint or whether missing observations affected results.

Additional details are also absent: the registry does not report the detailed statistical analysis plan, multiplicity handling, interim analyses, or sample-size justification. It lists six outcome measures and zero analyses. The title names satisfaction and narcotic usage, but numerical results for those outcomes are not reported in the registry record. The stated eligibility notation “EGA.37 weeks” is not clarified. These limitations constrain interpretation of both the intended methods and the study’s reported findings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery — NCT02533167.
• Registry record last updated 2018-09-05; status last verified 2018-08.
• Results first posted 2018-08-06.
• 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.

19. Record Summary

NCT02533167 is listed as a completed study sponsored by Wake Forest University Health Sciences. The registry records a single-group design, allocation NA, no masking, and enrollment of 70. The recorded start and primary completion are 2015-07 and 2015-12.

The intervention was skin-to-skin contact initiated in the operating room after cesarean delivery, as soon as feasible following newborn assessment. The stated goal was at least 60 minutes of contact. Maternal evoked pain was the primary endpoint, assessed with a 100 mm sliding visual analogue scale and summarized as a mean with standard deviation. The registry record does not report its numerical result.

The safety entry lists 55 at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. The record lists six outcome measures and zero analyses. It does not report the analysis population, missing-data handling, or a comparative control group.