Neonatal Outcome by Reason for Delivery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Neonatal Outcome by Reason for Delivery (NCT01818518), a registered phase not stated study. The primary outcome is Composite Perinatal Morbidity.

2. Clinical Question

3. Trial Design

NCT01818518, titled “Neonatal Outcome by Reason for Delivery,” is described in the registry as a prospective observational study sponsored by Obstetrix Medical Group. Its stated purpose is to determine the rate of composite neonatal morbidity among very preterm babies delivered following preterm labor compared with those delivered following prelabor rupture of membranes. The registry lists a further group of premature births before 32 weeks that are not classified as PTL or PROM.

The registry reports enrollment of 995 participants. The study began in 2013-07, reached primary completion on 2016-05-03, and is marked completed. The primary outcome concerns newborns of enrolled female participants, with follow-up from birth until discharge or until the infant reaches 28 days of life. These details describe the planned population and outcome period; the record does not report the number of infants with evaluable outcome data.

The study is observational rather than randomized. Allocation is not stated in the registry record, and the groups should not be read as a randomized, like-for-like control comparison. Reasons for delivery may be associated with other characteristics that also relate to neonatal outcomes. The registry record does not report whether or how such factors were measured or adjusted for in an analysis.

One primary outcome measure is listed, but no statistical analyses are posted in the registry record. Numerical event counts, group-specific rates, effect estimates, confidence intervals, and p-values are not reported in the registry record. The statistical analysis plan, any planned sample-size justification, and details of participant flow are also not reported in the registry record.

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

Analysis population for the primary outcome, as defined in the registry: Composite morbidity is defined as ≥ 1 of the following: RDS, BPD, severe IVH (grades III or IV), PVL, blood culture-proven sepsis present within 72 hours of birth, NEC, or perinatal death. Perinatal Morbidity assessed pertains to the newborns born to the enrolled female patients.

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.

Only the first 6 of 7 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Composite Perinatal Morbidity, measured over Infants from birth until discharge or until infant reaches 28 days of life..

The primary endpoint is composite perinatal morbidity in newborns born to enrolled female participants. An infant meets the composite definition if at least one listed outcome occurs: respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), severe intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death. The registry specifies RDS using oxygen requirement, clinical diagnosis, and a consistent chest radiograph; BPD by oxygen support at 28 days of life; and severe IVH as grades III or IV. The primary outcome description specifies blood culture-proven sepsis present within 72 hours of birth, and defines perinatal death as stillbirth or neonatal death before hospital discharge.

A composite can capture whether a participant experiences any event from a set of outcomes, rather than reporting only one condition. This can be useful when a study is concerned with a broad pattern of morbidity. However, the composite does not by itself show which component occurred, whether components were equally frequent, or how much each contributed to an overall group difference. Those component counts and the primary outcome results are not reported in the registry record.

The outcome period is from birth until discharge or until the infant reaches 28 days of life. The registry lists the endpoint as a participant count, but does not report observed counts or rates for the groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a prospective observational study and identifies a binary primary endpoint: whether an infant has at least one specified morbidity event or perinatal death during the stated outcome period. The record does not report the statistical analysis methods used, so the explanations below describe general concepts relevant to this kind of outcome rather than methods confirmed for this study.

What does a binary endpoint represent?

A binary endpoint classifies each infant as having or not having the composite event. Group summaries commonly express the number of infants with an event in relation to the number assessed in that group. The registry lists the endpoint in participant counts, but does not report those counts, group denominators, or calculated rates. Without them, the frequency of the endpoint and any comparison between groups remain unknown.

In an observational comparison, the groups are defined by delivery circumstances rather than random assignment. A simple comparison of group event rates would describe the observed data, but group composition could differ in ways relevant to the outcome. An adjusted analysis can attempt to account for measured characteristics, but its interpretation depends on which variables were collected, how they were modeled, and whether the assumptions of the model are reasonable. Those details are not reported in the registry record. Statistical adjustment also cannot automatically remove bias from unmeasured or poorly measured factors.

How should an effect estimate and its uncertainty be read?

An effect estimate describes the size and direction of a contrast between groups according to a chosen measure, such as a difference in event rates or a relative measure. A confidence interval describes the range of values reasonably compatible with the data and the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while an interval that includes values corresponding to no difference may leave the direction or size of an association uncertain. These are general interpretations; the registry record contains no effect estimate or confidence interval for this study.

A p-value, when reported, summarizes how incompatible the observed data are with a specified null model under the assumptions used. It is not a measure of the probability that the null hypothesis is true, nor does it quantify clinical importance. The registry record reports no p-values and does not describe a statistical testing plan. Statistical significance, precision, and the practical size of an association are distinct questions and should not be treated as interchangeable.

Why does the composite definition matter?

A composite endpoint combines several component outcomes into one indicator. This may provide a broad summary, but interpretation depends on the definition and on the component events. The listed outcomes are not identical in type: they include respiratory, neurologic, infectious, gastrointestinal, and mortality outcomes. An overall result could be driven by one or more components, and the combined endpoint alone would not identify which ones. Component-specific counts and estimates would help explain the composition of the outcome, but are not reported in the registry record.

The observation window also defines what qualifies as an event. The registry describes follow-up from birth until discharge or until the infant reaches 28 days of life, with specific definitions for several components. Differences in follow-up or event ascertainment can affect which outcomes are recorded. The record does not report how missing or incomplete follow-up was handled, how event definitions were applied in practice, or whether outcome assessment was standardized across groups.

What do planning calculations mean?

Sample-size calculations are planning illustrations, not observed findings and not evidence that a study had a particular probability of detecting an effect after it was completed. A planning calculation depends on assumptions about the effect to detect, significance level, allocation, and statistical approximation. The registry does not report the study's own sample-size justification or a planned effect size. No observed effect is reported, so an effect-based planning illustration cannot be interpreted as a result of this study. Any planning values should be understood as conditional on their stated assumptions, not as estimates of what occurred among participants.

Overall, the design and endpoint permit a description of morbidity by delivery reason if suitable data and analyses are available. The registry record does not post the numerical data or analysis details needed to assess the observed association, its uncertainty, or the robustness of a statistical model.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure, but does not report a statistical analysis plan, a hierarchy of hypotheses, or the number of planned comparisons. It is therefore not possible to determine whether the PTL-versus-PROM comparison was the sole planned comparison, whether the additional delivery-reason group was included in formal testing, or whether analyses of individual composite components were planned. The handling of multiplicity is not reported in the registry record.

Missing-data methods are also not reported in the registry record. The record does not state how infants with incomplete follow-up, unavailable outcome information, or uncertain component status were treated. It does not report the numbers of missing observations, whether exclusions occurred, or whether any sensitivity analyses assessed the effect of missing data. These details matter because an analysis limited to infants with complete outcome information can be biased if completeness is related to delivery group or outcome.

The analysis population is not reported in the registry record. Although enrollment is listed as 995 participants, this does not indicate how many infants contributed to each analysis, whether all enrolled participants were included, or how multiple births or other participant-level details were handled. No account of participant flow, exclusions, or analyzed denominators is posted.

These omissions limit assessment of the validity and reproducibility of any comparison. They do not establish that multiplicity or missing data were mishandled; rather, the registry record does not provide enough information to evaluate those issues.

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

The record establishes that the study set out to describe composite neonatal morbidity by reason for very preterm delivery and that it defined a composite covering several neonatal complications and perinatal death. It also records the observational nature of the study, its enrollment, and the outcome period. These details help clarify the intended research question and what counted as an event.

The record does not provide the numerical results needed to answer the study question. It reports no group-specific event counts or rates, no estimate of the contrast between PTL and PROM, and no measure of precision. It therefore does not show whether morbidity was more common in one group, whether the groups had similar rates, or whether any apparent difference was compatible with substantial uncertainty. No conclusion about statistical significance can be made from the registry record.

Even if group results were available, an observational comparison would not by itself establish causation. PTL and PROM groups may differ in other characteristics relevant to neonatal outcomes. The registry record does not report the adjustment strategy or the information needed to judge whether confounding was addressed.

The composite also does not represent a single specific condition. It counts the occurrence of at least one among several listed outcomes, and a combined result would not reveal which components account for the observed morbidity. Component-level findings and sufficient information about follow-up and missing data would be needed for a fuller interpretation.

Accordingly, the registry record documents a completed study with a stated question and outcome definition, but does not support a conclusion about the observed relationship between delivery reason and neonatal morbidity. The absence of posted results should not be interpreted as showing no association.

12. Why This Trial Matters Statistically

This study addresses a statistical question where the groups arise from different clinical circumstances rather than assignment to a study treatment. That distinction shapes the interpretation: any comparison would describe how outcomes differed among the observed delivery-reason groups, while causal interpretation would require careful consideration of other factors that could distinguish them.

The endpoint also illustrates a common trade-off in clinical research. A composite can summarize a broad set of outcomes with one indicator, but the combined result may conceal which components are most frequent or most influential. Clear definitions help specify what is counted, while component-level reporting is needed to understand the pattern behind a composite finding. The registry defines multiple components but does not report their observed counts.

Statistical precision depends on event counts and analyzed group sizes, not enrollment alone. Although enrollment is listed as 995 participants, group denominators and outcome counts are not reported in the registry record. Without these, readers cannot evaluate the uncertainty around a rate or comparison. The lack of a posted analysis also prevents assessment of adjustment, missing-data handling, and multiplicity.

The record therefore demonstrates why a clearly stated question and endpoint are only part of the evidence needed for statistical interpretation. Numerical results, analysis methods, and transparent reporting of the population analyzed are necessary to judge the size and reliability of an observed association. In their absence, the study's stated objective can be understood, but its empirical answer cannot be assessed from the registry record.

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 trial-specific limitation for interpreting the registry entry is that it contains no numerical primary outcome results. Group event counts, denominators, rates, effect estimates, confidence intervals, and p-values are not reported in the registry record. The number of infants contributing outcome data is also not reported, so the listed enrollment cannot establish the precision or completeness of the primary comparison.

The study is observational, and allocation is not stated in the registry record. The record does not describe measured baseline characteristics, potential confounders, or an adjustment strategy. A comparison by reason for delivery could therefore reflect differences in group composition as well as any association with delivery reason. The information needed to assess this possibility is not reported in the registry record.

The composite includes multiple kinds of neonatal outcomes and perinatal death. Although the definitions are described, component-specific event counts and results are not reported. The registry also does not report how outcomes were ascertained, whether adjudication procedures were used, or how any uncertainty in classification was handled.

Further details that would support appraisal are not reported in the registry record, including the statistical analysis plan, sample-size justification, missing-data methods, analysis populations, participant flow, and planned handling of multiple comparisons. These reporting gaps prevent evaluation of the analysis strategy and its robustness. They do not show that the study methods were necessarily inadequate; they limit what can be concluded from the information recorded.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Neonatal Outcome by Reason for Delivery — NCT01818518.
• Registry record last updated 2019-06-18; status last verified 2019-06.
• Results first posted 2019-06-07.
• 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

NCT01818518 is a completed prospective observational study titled “Neonatal Outcome by Reason for Delivery,” sponsored by Obstetrix Medical Group. The registry reports enrollment of 995 participants, a start in 2013-07, and primary completion on 2016-05-03. The stated objective is to assess composite neonatal morbidity among very preterm births following PTL versus PROM; a group of premature births before 32 weeks not including PTL or PROM is also described.

The primary outcome is a composite of at least one specified neonatal morbidity or perinatal death, assessed from birth until discharge or until the infant reaches 28 days of life. The registry record lists one outcome measure but no statistical analyses. Numerical outcome findings, group denominators, effect estimates, and analysis methods are not reported in the registry record. The study's statistical results and the strength or direction of any association therefore cannot be assessed from the registry record.