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 Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds (NCT05653362), a randomized na study. The primary outcome is Quality of Ultrasound Images.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05653362 |
| Phase | NA |
| Condition | Pregnancy, High Risk |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Indiana University |
| Results posted | Yes |
2. Clinical Question
Population
Pregnant patients with high-risk pregnancies were the study population. The registry record lists an enrollment of 40. Further eligibility details, such as specific pregnancy characteristics, are not reported in the registry record.
Intervention
Coconut oil was used as a coupling medium during obstetric ultrasound imaging. Participants were to have three study images obtained with coconut oil and three with commercial ultrasound gel.
Comparator
The comparator was commercial ultrasound gel, the other coupling medium used for the study images. The record describes randomization to an order of use, with one medium used before the other.
Primary question
The primary question was whether image quality scores differed between images obtained using coconut oil and those obtained using commercial ultrasound gel. Patient acceptability was also assessed as a secondary outcome.
This is a within-participant comparison: each participant was described as receiving both coupling media during the ultrasound. That design allows the study to compare the two media within the same person rather than assigning each person to only one medium. The record describes randomization of the order, which is relevant because the first or second scan could differ for reasons unrelated to the coupling medium.
The primary image-quality assessment used a quantifiable scale developed for the study. Two experienced Maternal-Fetal Medicine physicians rated the images while blinded to the coupling agent and the randomization list; their scores were averaged. Acceptability was assessed with a 10-question, 5-point Likert scale survey after the ultrasound. Numerical results for either outcome are not reported in the registry record, so the registry record does not establish how the two media compared on image quality or acceptability.
3. Trial Design
The registry record describes a randomized, single-masked, crossover trial with an enrollment of 40. It lists coconut oil and commercial ultrasound gel as the two coupling media. In a crossover design, each participant receives both conditions, so comparisons can be made within participants. The record says that participants would have six study images obtained: three using each medium.
Randomization was used to determine the order in which the media were used. The listed sequence titles are coconut oil followed by commercial ultrasound gel, and commercial ultrasound gel followed by coconut oil. However, the descriptions attached to both sequence titles repeat wording that says the images would be obtained first with coconut oil and then with commercial gel. The sequence descriptions are therefore not fully consistent, and the precise implementation of the two orders is not clear from the registry record.
The image set included three specified image types for each coupling medium: Biparietal Diameter/Head circumference (BPD/HC), abdominal circumference (AC), and femur length (FL). The image ratings were made by two experienced Maternal-Fetal Medicine physicians. The record says those physicians were blinded to the agent used for each image and had no knowledge of the randomization list. It identifies the trial as single-masked but does not report who else, if anyone, was masked.
Participants were also to complete a 10-question, 5-point Likert scale survey about acceptability after the ultrasound using both media. The ultrasound scanning timeframe is described as an average of 1 hour. The record lists the study as completed, with an enrollment of 40, but does not report the date of completion or numerical findings.
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 | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 20 | 20 |
| 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 | Coconut Oil Followed by Commercial Ultrasound Gel | Commercial Ultrasound Gel Followed by Coconut Oil | Total |
|---|---|---|---|---|
| Participants analysed | 20 | 20 | 40 | |
| Age, Continuous | Years | — | — | — |
| Sex: Female, Male: Female | Participants | 20 | 20 | 40 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 20 | 20 | 40 |
6. Primary Endpoint
The registry lists the primary outcome as Quality of Ultrasound Images, measured over ultrasound scanning, an average of 1 hour.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the quality of ultrasound images obtained with coconut oil compared with commercial ultrasound gel. Image quality was rated on a study-developed scale from 0 to 100. Scores from 0-25 were categorized as unacceptable, 26-50 as suboptimal, 51-75 as acceptable, and 76-100 as optimal. The registry record describes the primary measure as a mean score, with standard error as its dispersion measure.
For each coupling medium, the three specified image types were evaluated. Two experienced Maternal-Fetal Medicine physicians rated the images, and their ratings were averaged to produce a score for each image per coupling agent. The physicians were blinded to which agent had been used and to the randomization list. This procedure is intended to reduce the influence of knowledge about the coupling medium on image ratings.
Image quality is relevant to this comparison because the study asks whether the images obtained with one coupling medium receive different quality scores from those obtained with the other. The scale also gives descriptive categories for interpreting scores. However, the registry record does not report the observed scores, a comparison estimate, or uncertainty around a comparison. It therefore does not indicate which quality category the images reached or whether scores differed between the media. Acceptability was registered as a secondary outcome, but its numerical results are also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record documents the study question, design, image-rating process, and intended acceptability assessment. It does not report outcome values for image quality or acceptability. No mean scores, comparison estimates, confidence intervals, p-values, or analysis results are reported in the registry record. As a result, the posted record does not allow a reader to assess the direction or magnitude of any observed difference between coconut oil and commercial ultrasound gel.
The image-quality endpoint is described as a mean on a scale with categories ranging from unacceptable to optimal. Knowing the scale and its categories explains what the investigators intended to measure, but it does not reveal the observed quality of the images. The same applies to the acceptability survey: the record describes its 10 questions and 5-point response scale but does not give survey scores or a comparison between the media.
The crossover design means that participants were intended to receive both coupling media. In general, a within-participant comparison can account for stable differences between participants, since each person contributes experience under both conditions. The analysis still needs to address features of the design, including the order of use and the fact that multiple images are obtained from each participant. The registry record does not report the statistical model or other methods used to account for these features.
The image ratings were made by two physicians and averaged for each image per coupling agent, as described in the record. This clarifies how ratings were combined, but the record does not report individual scores, agreement between raters, or the final results by coupling medium. The extent to which image ratings varied between images or participants is also not reported.
Although the record lists the study as completed and an enrollment of 40, completion status is not a substitute for results. It does not establish that every planned image or survey was available for analysis, nor does it show how missing observations were handled. Participant flow, exclusions, and analysis populations are not reported in the registry record.
Any sample-size figures elsewhere in the posted material should be read as planning illustrations under their stated assumptions, not as evidence about the precision of the trial results or as observed power. The registry record gives no numerical effect estimates to interpret alongside those illustrations. With no reported outcome analysis, the central statistical conclusion is that the registry entry is insufficient to determine the comparative image-quality or acceptability findings.
9. Statistical Methods Explained
The registry record identifies a randomized crossover design and describes how image quality was to be rated. It does not report the statistical analysis used for the primary comparison. The following explanations describe general statistical concepts relevant to the stated design; they should not be taken as a claim that a particular method was used in this trial.
What does a crossover design imply for analysis?
In a crossover study, each participant receives both study conditions. A comparison can therefore use the within-participant difference between measurements made under the two conditions. In general, this can help separate the effect associated with the study condition from stable characteristics that differ between people. It also means the observations are not independent in the way observations from separate groups would be: measurements from the same participant are related.
That relationship needs to be reflected in an analysis. A paired comparison or a model that accounts for participant-level clustering may be suitable in general, depending on the outcome and study plan. The registry record does not report whether the investigators used a paired test, a mixed model, another method, or any adjustment for participant-level dependence. It also does not report an analysis plan for the randomized order.
Why can order matter?
When a participant receives both conditions, the order can matter if the first and second measurement differ for reasons other than the coupling medium. General examples include changes over the course of a procedure or effects of having received the first condition. Randomizing the order can help balance such influences across sequences, but it does not by itself show how order was handled in the analysis. Here, the registry lists two sequence titles, but the descriptions attached to them repeat the same coconut-oil-first wording. The actual sequence implementation and any analysis of sequence or period effects are not reported clearly in the registry record.
How should the image scores be understood?
The primary measure is described as a mean score on a scale from 0 to 100, with standard error as the dispersion measure. A mean describes the average score in the group of observations being summarized. A standard error describes the precision of an estimated mean: in general, a smaller standard error indicates a more precisely estimated mean, while it does not describe the full spread of individual scores. The registry record does not give the means or standard errors, so neither the average scores nor their precision can be assessed from the registry entry.
The scale also groups scores into four descriptive categories: unacceptable, suboptimal, acceptable, and optimal, with the stated score ranges. These categories make the scale easier to interpret descriptively. They do not replace a comparison estimate or convey how uncertain a mean or difference is. No score distribution or category count is reported in the registry record.
What does a confidence interval usually add?
In general, a confidence interval gives a range of values compatible with the data and a specified statistical procedure. It communicates uncertainty around an estimate, whereas a point estimate alone does not. The registry record does not report a confidence interval for the comparison of image quality, or for acceptability. Without a comparison estimate and its uncertainty, it is not possible to judge the size or precision of a difference from the posted registry results.
What is the role of hypothesis tests?
A p-value, when reported, summarizes how compatible the observed data are with a specified null hypothesis under the assumptions of a statistical test. It does not measure the size or importance of an effect, and it does not by itself establish that two conditions are equivalent. The registry record lists no analyses and reports no p-value or test result. The statistical plan, including any chosen hypothesis test or decision threshold, is not reported in the registry record.
What do the sample-size assumptions mean?
The stated sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are described as participants per arm; time-to-event examples use a total event count. These are planning assumptions, not a report of the trial's own design justification and not observed power. The registry record does not report the trial's sample-size justification or a statistical plan showing that these assumptions governed enrollment. In addition, the described trial is a crossover study, so an illustration framed around allocation between two arms should not be mistaken for a description of its within-participant analysis.
Overall, these concepts explain what an analysis could need to address, but they cannot reconstruct the trial's results or methods. The registry record does not report the analysis model, estimates, uncertainty intervals, hypothesis tests, or handling of the repeated images and survey observations.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures and identifies image quality as the primary outcome and acceptability as a secondary outcome. It describes three image types for each coupling medium and a multi-question acceptability survey. The record does not report whether there was a prespecified hierarchy among image types, a primary summary across image types, or a plan for controlling the risk of false-positive findings when making multiple comparisons. A multiplicity adjustment or other approach to multiple testing is not reported in the registry record.
The record also does not report a numerical analysis for the primary endpoint or the secondary acceptability outcome. It lists no analyses, and no outcome estimates or test results are included. Therefore, there is no reported result from which to assess whether multiple testing affected the interpretation.
Missing-data handling is not reported in the registry record. The enrollment and planned image collection are described, but the record does not state how many participants contributed usable images or surveys, whether any observations were missing, or how missing observations were addressed. It also does not report participant flow or reasons for any exclusions.
The analysis population is not specified. The record does not say whether analyses included all randomized participants, only participants with complete measurements, or another group. These details matter because the number and pattern of observations available can affect both the estimated comparison and its uncertainty, particularly in a crossover design where a within-participant comparison depends on measurements under both conditions.
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 |
|---|---|---|---|
| Coconut Oil | 0 | 40 | 0.0% |
| Ultrasound Gel | 0 | 40 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Coconut Oil | 0 of 40 |
| Ultrasound Gel | 0 of 40 |
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 |
|---|---|
| Coconut Oil | 0 of 40 |
| Ultrasound Gel | 0 of 40 |
The registry's safety entries list coconut oil and ultrasound gel separately. For each listed group, the record gives 40 participants at risk for serious adverse events and 0 affected; it also gives 40 at risk for other adverse events and 0 affected. Deaths are listed as 0 in each group. These entries describe what was recorded in the safety fields; they do not provide detail about surveillance procedures or event definitions.
Because this is a crossover trial, the safety entries should not be read as evidence of two separate groups of participants. The record lists both coupling media as groups, while participants were intended to receive both. The safety figures therefore do not establish how exposure periods were handled or whether events were attributed to one medium, both, or neither. Those details are not reported in the registry record.
Zero events in the posted fields means no events are listed for those categories in this registry entry. It does not establish that the study could rule out uncommon harms, nor does it provide a comparison estimate with uncertainty. The registry record does not report further safety analysis or a detailed narrative of adverse events.
12. What the Result Does, and Does Not, Mean
The record shows that a randomized crossover trial was conducted to compare coconut oil with commercial ultrasound gel for obstetric ultrasound imaging. Its primary planned measure was image quality, rated on a study-developed scale by physicians blinded to the coupling agent and randomization list. Patient acceptability was also assessed through a survey after use of both media. These descriptions clarify the research question and measurement approach.
The registry record does not report the numerical image-quality scores, acceptability results, or statistical comparisons. It therefore cannot establish whether scores were higher with either medium, whether any difference was large or small, or how precise an estimate might be. It also cannot establish that the media produced equivalent results: a lack of reported comparison results is not evidence of equivalence.
The record lists no analyses, and it does not give a statistical plan, confidence intervals, p-values, participant flow, or missing-data methods. As a result, readers cannot assess how repeated images, within-participant measurements, sequence, or missing observations were handled in the analysis. The listed safety fields record zero affected for the stated adverse-event categories, but the entry does not include a detailed safety analysis.
General statistical interpretation requires both an estimate and information about its uncertainty, alongside a clear account of how observations were analyzed. The registry entry provides neither for the main comparison. Its completion status and enrollment figure describe the study record, not the direction or certainty of its findings. Any planning illustrations are distinct from observed results and should not be interpreted as proof of precision, efficacy, or equivalence.
13. Why This Trial Matters Statistically
This trial is statistically notable for its crossover structure. Each participant was intended to contribute images obtained with both coupling media, creating a within-participant comparison. In general, such designs can reduce the influence of stable between-person differences, but they require appropriate handling of the relationship between observations from the same person. The registry record does not report whether or how that dependence was incorporated in the analysis.
The outcome also involves repeated measurements: three specified image types were to be obtained with each medium, and two physicians rated the images before their ratings were averaged. This raises useful statistical questions about how image-level scores are summarized, how repeated observations are accounted for, and whether the results vary by image type. The record describes the rating process but reports no statistical analysis or image-level results.
Randomized order is relevant because measurements collected first and second may differ for reasons unrelated to the medium. The registry lists two order titles, but their written descriptions are inconsistent. This makes the sequence implementation difficult to establish from the record, and no analysis of order is reported.
Finally, the gap between a detailed measurement description and absent results is important for interpretation. The record specifies a scale, blinding of image raters, and an acceptability survey, but gives no outcome estimates or uncertainty. It can therefore support an understanding of the design and intended measures, not a statistical conclusion about comparative image quality or acceptability.
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.
Important design and reporting details are not available in the registry record. Although the trial is identified as randomized and crossover, the written descriptions for the two randomized sequences repeat the same coconut-oil-first order. The sequence titles indicate opposite orders, but the accompanying text does not clearly confirm how both orders were implemented. The record also does not report how order or period effects were addressed.
The image-quality scale was developed for the study, but information about its validation or measurement properties is not reported in the registry record. The record says two experienced Maternal-Fetal Medicine physicians rated the images and that their scores were averaged. It does not report the degree of agreement between raters or whether the assessment process was evaluated for consistency.
Numerical results are absent for both image quality and acceptability. The registry record does not report participant flow, missing-data handling, analysis populations, or the statistical method used to account for multiple images within participants. It also does not state how multiple outcomes or image types were handled in statistical testing. These omissions prevent assessment of the precision and robustness of the intended comparisons.
The record identifies the population as high-risk pregnancy but does not report further eligibility characteristics or detailed participant characteristics. The extent to which the findings might apply beyond the enrolled study population cannot be evaluated from the registry record. The record lists safety counts but does not report detailed safety monitoring or attribution methods. Finally, although the study is marked completed, its numerical findings are not reported, so the registry entry cannot support a conclusion about the comparative outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds — NCT05653362.
- Registry record last updated 2023-06-02; status last verified 2023-05.
- Results first posted 2023-06-02.
- 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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18. Record Summary
The registry record describes NCT05653362, a randomized, single-masked crossover trial comparing coconut oil with commercial ultrasound gel during obstetric ultrasounds. It lists Indiana University as sponsor, an enrollment of 40, and the condition Pregnancy, High Risk. The study status is completed.
Participants were to have three study images obtained with each coupling medium. Image quality was assessed on a study-developed scale, with two experienced Maternal-Fetal Medicine physicians blinded to the agent and randomization list; their ratings were averaged. Acceptability was assessed with a 10-question, 5-point Likert scale survey. The record lists image quality as the primary outcome and acceptability as a secondary outcome.
Numerical results and statistical analyses are not reported in the registry record. The listed safety entries show 0 serious adverse events, 0 other adverse events, and 0 deaths for each coupling-medium group. Details of analysis methods, missing data, and participant flow are not reported.