This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for The Effect of Video Education on Skin-to-Skin at the Time of Delivery (NCT03200925), a randomized na study. The primary outcome is Intention to Practice Skin-to-skin Contact After Birth.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03200925 |
| Phase | NA |
| Condition | Kangaroo Care, Video, Prenatal Education |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 240 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Kettering Health Network |
| Results posted | Yes |
2. Clinical Question
The study asks whether a short prenatal video about skin-to-skin contact is associated with a change in participants’ stated intention to practice skin-to-skin contact after birth. It also describes a secondary question: whether participants were able to have skin-to-skin contact within five minutes of delivery. The registry record does not report results for either question.
Population
Pregnant participants admitted for delivery who were enrolled in the study. Planned enrollment was 240. Further eligibility details are not reported in the registry record.
Intervention
A short video, “Jumping into Kangaroo Care,” created by the Ohio Department of Health. Participants in the video group completed a follow-up question about intention after watching it.
Comparator
The no-video group completed the brief survey without watching the video. Both groups were asked about their intention to practice skin-to-skin contact at delivery.
Primary question
How did stated intention to practice skin-to-skin contact after birth compare between the study groups? The registry record does not report an analyzed comparison or its result.
The practical focus is the relationship between prenatal education and an intention reported around delivery. The study description also identifies actual skin-to-skin participation as an outcome of interest, with participation assessed within five minutes of delivery. These are related but distinct questions: a stated plan is not the same measure as recorded participation. The registry record does not report whether the video changed intention, whether any change was maintained through delivery, or how the groups compared on actual participation.
3. Trial Design
The study is listed as completed and randomized, with a parallel-group design and single masking. Planned enrollment was 240. The registry record lists the phase as NA. Kettering Health Network is named as the sponsor. The study began on 2017-06-23, and primary completion is dated 2017-10-26.
Participants were assigned to a no-video group or a video group. Both groups completed a short survey about intention to practice skin-to-skin contact at the time of delivery. The survey also asked about skin-to-skin experience in a previous pregnancy and prior formal education. The video group watched “Jumping into Kangaroo Care” and then answered a follow-up question about intention. Participants were followed until after delivery to assess whether they participated in skin-to-skin contact.
The registry record does not identify which person or aspect of the study was masked. It does not report the method used to generate or conceal the random assignment, whether assignment was stratified, or whether participants and study staff knew the group assignments. Those details should not be inferred from the single-masking label.
The intervention was a brief educational video, rather than a medication or procedure. The record describes intention as the primary outcome and participation within five minutes of delivery as a secondary endpoint. The primary outcome has several categories or time points in the record and is not reduced to a single comparison. Although the study is marked completed, no analyzed primary or secondary outcome results are reported. The participant flow, exclusions after randomization, and analysis populations are 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
| Stage | Group A - no Video Group | Group B - Video Group |
|---|---|---|
| STARTED | 120 | 120 |
| COMPLETED | 120 | 120 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | Group A - no Video Group | Group B - Video Group | Total |
|---|---|---|---|---|
| Participants analysed | 120 | 120 | 240 | |
| Age, Continuous | years | 27.1 (SD 5.5) | 27 (SD 5.1) | 27 (SD 5.3) |
| Sex: Female, Male: Female | Participants | 120 | 120 | 240 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Caucasian | Participants | 90 | 98 | 188 |
| Race/Ethnicity, Customized: African American | Participants | 22 | 12 | 34 |
| Race/Ethnicity, Customized: Hispanic | Participants | 4 | 1 | 5 |
| Race/Ethnicity, Customized: Other | Participants | 4 | 9 | 13 |
| Primiparous | Participants | 53 | 55 | 108 |
| Private Insurance | Participants | 55 | 58 | 113 |
| Medicaid | Participants | 61 | 58 | 119 |
| Comorbidities: Chronic Hypertension | Participants | 5 | 3 | 8 |
| Comorbidities: Gestational Hypertension | Participants | 6 | 10 | 16 |
| Comorbidities: Preeclampsia | Participants | 3 | 2 | 5 |
| Comorbidities: Gestational Diabetes Mellitus | Participants | 4 | 9 | 13 |
| Comorbidities: Asthma | Participants | 10 | 10 | 20 |
| Comorbidities: Neurologic Disease | Participants | 4 | 1 | 5 |
| Comorbidities: Hematologic Disease | Participants | 13 | 9 | 22 |
| Comorbidities: Other Medical Comorbitities | Participants | 40 | 42 | 82 |
| Obstetric Measures: Spontaneous Vaginal Delivery | Participants | 84 | 89 | 173 |
| Obstetric Measures: Vacuum Delivery | Participants | 11 | 9 | 20 |
| Obstetric Measures: Low Transverse Cesarean Delivery | Participants | 25 | 22 | 47 |
| Gestational Age (weeks) | weeks | 39 (37 to 41) | 39 (37 to 41) | 39 (37 to 41) |
| 5 Minute APGAR Score | units on a scale | 9 (7 to 9) | 9 (8 to 10) | 9 (7 to 10) |
6. Primary Endpoint
The registry lists the primary outcome as Intention to Practice Skin-to-skin Contact After Birth, measured over 1 day.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Intention to Practice Skin-to-skin Contact After Birth.” It concerns participants’ stated intention, recorded through a questionnaire item asking whether they planned to participate in skin-to-skin contact, also called kangaroo care, immediately after birth. The registry record gives a timeframe of 1 day and identifies the unit as participants.
The endpoint is used to assess the immediate response to prenatal education. In the study description, both groups are asked about intention at admission, while the video group is asked again after watching the video. This means the record describes an immediate pre- and post-video question for the video group, alongside a no-video group’s survey response. The registry record does not report an analyzed comparison that clarifies how these measurements were combined or which time point posted the reported primary result.
Intention is a self-reported measure of a plan, not a direct measure of behavior. The secondary endpoint addresses a different outcome: whether a participant was able to take part in skin-to-skin contact within five minutes of delivery. Considering both outcomes can distinguish a reported intention from participation, but the registry record does not report results for either. It also does not report the questionnaire’s response categories, rules for incomplete answers, or a detailed endpoint analysis plan.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record contains no analyzed primary outcome result. It therefore does not establish the direction or size of any difference in intention between the video and no-video groups, and it does not report a confidence interval or significance test for that comparison. No conclusion about an effect on intention can be drawn from the posted results. The same limitation applies to the secondary endpoint concerning skin-to-skin participation within five minutes of delivery.
The study description outlines a comparison, but a study objective and hypothesis are not results. In particular, the stated hypothesis that video education would increase knowledge and encourage intention is not evidence that intention changed. The enrollment target and group descriptions also do not indicate how many participants completed each survey or contributed to an outcome analysis. The registry record does not report those counts.
The timing of the questions matters for interpreting a future comparison. The video group was asked about intention after watching the video, whereas the no-video group completed the brief survey without that video follow-up. A clear analysis would need to specify which responses are being compared and how the repeated question in the video group is handled. The registry record does not report that analysis. It also does not report whether the groups’ baseline intentions were compared or whether any adjustment was made.
General statistical interpretation: an effect estimate describes the observed contrast between groups, while a confidence interval describes the uncertainty around that estimate under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but neither an estimate nor its interval is available for the primary comparison in the registry record. A p-value, if reported, would address compatibility of the data with a specified null hypothesis; it would not by itself describe the magnitude or practical importance of a difference. No p-value is reported for the primary endpoint.
Because the primary outcome result is absent, the effect cannot be judged for precision, and the role of chance cannot be assessed from the record. There is also no reported result for actual participation to assess whether stated intention corresponded with behavior. These are limitations in what can be interpreted from the registry record, rather than evidence for either a positive or a null effect.
9. Statistical Methods Explained
The registry record identifies a randomized, parallel-group study. Random assignment is intended to create groups that are comparable on average at the point of assignment, so that a later group contrast can be interpreted in relation to the assigned intervention. General statistical explanation: randomization does not guarantee that every characteristic will be balanced in a particular study, and it does not eliminate the need to report how participants were analyzed. The record does not report the randomization method or a primary statistical analysis.
What kind of outcome is described?
The primary endpoint concerns a participant’s intention, recorded by questionnaire. The outcome is described as a count of participants, and the study description indicates responses about whether the participant planned to use skin-to-skin contact. The registry record also notes that the primary outcome includes several categories or time points and was not reduced to one comparison. Without the response categories, group counts, or a specified analysis, an effect estimate cannot be reconstructed from the record.
General statistical explanation: for a binary outcome, a group comparison can be expressed using a difference in event proportions, a relative measure, or another prespecified contrast. Each scale answers a somewhat different question. A clear report identifies the event definition, analysis population, contrast, and uncertainty measure. No such analyzed estimate is reported for this endpoint.
How should uncertainty be understood?
General statistical explanation: a confidence interval gives a range of values compatible with the observed data under the model and its assumptions. It communicates precision as well as direction and magnitude. An interval that spans values on both sides of a null contrast may be compatible with several interpretations; the interval’s width and the clinical context matter. A p-value is not an effect size and does not measure the probability that a hypothesis is true. The registry record does not report an interval or p-value for the primary endpoint, so precision and statistical evidence cannot be evaluated.
What do the planning illustrations represent?
Any sample-size figures associated with planning illustrations should be read as planning calculations, not as observed power or as the study’s original design justification. The stated calculation assumptions are a two-sided significance level of 0.05, equal allocation between the groups, and a normal approximation. The illustration uses a stated fraction of the observed effect as the effect to detect. The registry record does not report the trial’s own sample-size justification, and no primary effect estimate is reported in the results. Such calculations cannot fill that evidence gap or establish that the study had adequate precision.
General statistical explanation: planning calculations describe the sample size associated with chosen assumptions about an effect, error rate, allocation, and analysis method. If the assumed effect changes, the resulting planning requirement can change too. A calculation based on an observed effect is especially dependent on that estimate and should be treated as an illustration rather than proof that the trial was adequately powered. A sample-size target is not the number analyzed, and it does not substitute for reporting estimates and confidence intervals.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. If ignored, uncertainty estimates from some models can be too small, which can make results appear more precise than they are. Model choice should fit the type and distribution of the outcome. The primary endpoint is described as participant counts, but the registry record does not report a model, a dispersion assessment, or an analysis that would allow over-dispersion to be evaluated.
The study has a distinct behavioral secondary endpoint: participation in skin-to-skin contact within five minutes of delivery. Its analysis would require a clear definition of who was eligible for assessment and how inability to participate, missing documentation, or other circumstances were classified. Those rules and the corresponding results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures, while identifying intention to practice skin-to-skin contact as the primary endpoint and participation within five minutes of delivery as a secondary endpoint. It also notes that the primary outcome has several categories or time points and is not reduced to one comparison. These features create questions about which contrast is the main test and how multiple outcomes or measurements are handled.
The statistical plan for multiplicity is not reported in the registry record. In general, testing several outcomes, categories, or time points can increase the chance of finding an apparently notable result by chance if each is treated as a separate confirmatory test. A prespecified hierarchy or adjustment can clarify how such testing is interpreted. The record does not state whether any such approach was planned or used.
Missing-data rules, the number of participants with missing responses, and the handling of incomplete questionnaires are not reported in the registry record. The record also does not report how participants who did not deliver at the study site, could not have skin-to-skin contact, or lacked documentation were handled for the secondary endpoint. These details affect which participants contribute to each outcome and how the result should be interpreted.
Analysis populations are not reported in the registry record. It is not stated whether participants were analyzed according to randomized group, according to the intervention received, or under another rule. No analysis results are reported, so the impact of missing information or population definitions cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Group A - no Video Group | 0 | 120 | 0.0% |
| Group B - Video Group | 0 | 120 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group A - no Video Group | 0 of 120 |
| Group B - Video Group | 0 of 120 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Group A - no Video Group | 0 of 120 |
| Group B - Video Group | 0 of 120 |
The registry record lists zero serious adverse events in each group. It lists 120 participants at risk in the no-video group and 120 in the video group. Other adverse events are also listed as zero in both groups, with 120 at risk in each. Deaths are listed as zero in each group.
These entries describe what is recorded in the registry; they do not establish that no adverse events occurred outside the record or that all possible harms were assessed. The record does not report adverse-event definitions, methods of collection, attribution rules, or detailed observation periods. It also does not list serious adverse-event terms. The safety entries should therefore be read as registry counts, not as a comprehensive assessment of safety or as proof that the intervention carries no risk.
General statistical explanation: a zero count is an observed count, not a guarantee that the underlying event risk is zero. Interpretation depends on the number and characteristics of participants assessed, the completeness of event ascertainment, and the period and definitions used. The registry record does not provide enough detail to evaluate those aspects beyond the listed counts and at-risk numbers.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized study was conducted to examine prenatal video education about skin-to-skin contact. It describes a no-video group, a video group, a questionnaire-based intention outcome, and a secondary question about participation within five minutes of delivery. It also records planned enrollment of 240 and marks the study completed.
What the record does not establish is whether the video changed intention, how large any group difference was, or how precisely that difference was estimated. No analyzed primary outcome result, uncertainty interval, or significance test is reported. The registry record also does not report a result for the secondary participation outcome. The study’s hypothesis cannot be treated as a finding.
Intention and behavior are not interchangeable. A participant may report an intention without later being able to act on it, and actual participation may depend on circumstances around delivery. The record’s separate outcomes reflect that distinction, but absent results it is not possible to assess whether intention and participation aligned in this study.
General statistical explanation: evidence about an average group contrast does not automatically describe every participant, and statistical uncertainty is distinct from clinical importance. A result would need an effect estimate and its uncertainty to support a careful assessment of both. In their absence, the appropriate interpretation is limited to the study’s design and outcome definitions. Neither a beneficial effect nor a lack of effect is demonstrated by the registry information.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between an educational intervention’s immediate effect on a stated intention and its relationship to a later behavior. The intention question is self-reported after a brief video in one group, while the study also proposes to assess participation after delivery. These outcomes address different stages of the pathway from education to action and should not be treated as interchangeable measures.
The timing of measurement is also important. The video group was asked about intention after viewing the video, while the no-video group completed a brief survey. Interpreting a comparison requires clarity about which responses are compared, whether repeated responses are analyzed, and how the timing is reflected in the estimand. The registry record does not report those analysis details or a primary result.
Random allocation is relevant because it offers a design-based way to compare groups, but transparent reporting remains necessary. Group counts, missing responses, analysis populations, effect estimates, and uncertainty would allow readers to judge how much information the trial provides. Those primary outcome results are not reported in the registry record.
The study therefore matters statistically as an example of why outcome definition and reporting are central to interpretation. The registry description identifies a question worth evaluating, but without analyzed results it cannot resolve that question. Distinguishing the study’s hypothesis from evidence in its results prevents overstatement and keeps conclusions aligned with what the record documents.
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.
Several limitations of interpretation arise from the registry record. It does not report analyzed results for the primary intention endpoint or the secondary participation endpoint. No group-specific outcome counts, effect estimates, confidence intervals, or p-values are reported, so the direction, magnitude, and precision of any comparison cannot be assessed.
The primary outcome description includes several categories or time points and is not reduced to one comparison. The record does not specify how those categories and measurements were combined for analysis. The video group answered an intention question after viewing the video, but the analysis plan for that follow-up in relation to the no-video group’s response is not reported.
The registry record does not report eligibility details beyond the study population description, participant flow, analysis populations, missing-data handling, or a statistical analysis plan. It also does not explain the single-masking designation or detail the method of randomization. These omissions limit assessment of the comparison’s conduct and potential sources of bias.
For the secondary endpoint, the record does not report how inability to participate, missing medical-record documentation, or other delivery circumstances were classified. The safety entries list zero events, but event definitions and ascertainment procedures are not reported. These limitations concern what can be evaluated from the registry record; they do not establish that the study was conducted improperly.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effect of Video Education on Skin-to-Skin at the Time of Delivery — NCT03200925.
- Registry record last updated 2019-08-02; status last verified 2019-07.
- Results first posted 2019-07-22.
- 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.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, randomized, parallel-group study of prenatal video education about skin-to-skin contact. Planned enrollment was 240. One group completed a brief survey without the video; the other watched “Jumping into Kangaroo Care” and answered a follow-up question about intention. The primary endpoint concerned intention to practice skin-to-skin contact after birth, and a secondary endpoint concerned participation within five minutes of delivery.
The sponsor is Kettering Health Network. The study began on 2017-06-23, with primary completion on 2017-10-26. The phase is listed as NA, and masking is listed as single. The registry record does not report analyzed outcome results, a primary statistical analysis, missing-data procedures, or analysis populations. Serious adverse events, other adverse events, and deaths are listed as zero in both groups, with 120 participants at risk in each group.