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 Efficacy Evaluation of Using Finger Stick Peripheral Blood for Point of Care Pregnancy Testing (NCT06747598), a registered phase not stated study. The primary outcome is Number of Participants With Positive POC Serum Pregnancy Test.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06747598 |
| Phase | Phase not stated |
| Condition | Pregnancy Testing |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Nebraska |
| Results posted | Yes |
2. Clinical Question
Population
Women with previously confirmed pregnancies. The outcome description states that 30 women were tested, and the registry lists enrollment of 30.
Intervention
A point-of-care pregnancy test using a peripheral serum specimen collected through a finger stick. The intervention is listed as a pregnancy test.
Comparator
No comparison arm or alternative test is reported. The record describes a single POC serum pregnancy test arm, not a like-for-like control comparison.
Primary question
Among participants with previously confirmed pregnancies, how many had a positive POC serum pregnancy test at enrollment? The registry reports that all 30 peripheral serum specimens tested positive.
The clinical question is about test positivity in a group already known to be pregnant. It is not a comparison of the finger-stick POC test with another test, and it does not assess results in people who are not pregnant. Those distinctions matter when interpreting diagnostic performance: the posted result describes the observed outcome in this particular group, rather than a full assessment of how well the test separates pregnant from nonpregnant people.
The registry describes a one-time test at enrollment. It does not report a comparative accuracy analysis, an estimate of sensitivity or specificity, or a prespecified threshold for agreement with another test. Details of how the earlier pregnancy confirmation was established are not reported in the registry record. The main question answered by the stated outcome is therefore narrower: whether the tested specimens from these previously confirmed pregnancies were reported as positive or negative by the POC test.
3. Trial Design
The registry identifies this study as a completed evaluation of finger-stick peripheral blood for point-of-care pregnancy testing. The sponsor is the University of Nebraska. The record gives a start date of 2025-02-26 and a primary completion date of 2025-08-01. Enrollment is listed as 30, and the condition is pregnancy testing.
The listed arm is the POC serum pregnancy test arm. Its description says that enrolled participants provide a peripheral serum specimen for POC pregnancy testing. The outcome description further states that a peripheral serum sample was collected through a finger stick from women with previously confirmed pregnancies, with results reported as positive or negative. The primary outcome timeframe is one test at enrollment.
This is not presented as a randomized comparison. The registry lists one test arm, and an allocation method or comparator arm is not stated. There is consequently no between-arm estimate to interpret. The registry record does not describe blinding, a reference-test comparison, repeat testing, or a protocol for resolving discordant results. Those design details are not reported in the registry record.
The record labels the study completed, but completion status alone does not provide information about how participants were recruited, whether every enrolled participant contributed a usable specimen, or whether the conduct followed a particular analysis plan. The listed outcome population says all 30 peripheral serum specimens tested positive. Further details about exclusions, specimen failures, or deviations are not reported in the registry record.
The record gives an enrollment figure and an outcome description, but it does not provide a randomized design or a control group. The findings should therefore be read as a descriptive account of the test results in the studied group, not as a comparative treatment or diagnostic trial estimate. A protocol, eligibility criteria, and detailed procedures 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 | POC Serum Pregnancy Test Arm |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All 30 peripheral serum specimens tested positive for pregnancy.
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 | POC Serum Pregnancy Test Arm |
|---|---|---|
| Participants analysed | 30 | |
| Age, Customized: Age | Participants | 30 |
| Sex/Gender, Customized: Female | Participants | 30 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Positive POC Serum Pregnancy Test, measured over One time test at time of enrollment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with a positive POC serum pregnancy test. It is a count outcome: each tested specimen is reported as positive or negative, and the endpoint records the number with a positive result. The registry specifies a one-time test at enrollment.
This endpoint is relevant to the stated study aim because it records whether the POC test returned a positive result in participants whose pregnancies had already been confirmed. The registry reports that all 30 peripheral serum specimens tested positive. The result is therefore a direct description of the observed test outcomes in this enrolled group.
The count does not, on its own, describe performance across the full range of people who might undergo pregnancy testing. The participants were already known to be pregnant, and no nonpregnant comparison group is reported. Without results from people who are not pregnant, this outcome cannot describe the frequency of positive results in that group or establish specificity. The record also does not report a direct comparison with a reference test, so agreement between tests cannot be assessed from the stated endpoint.
The registry gives no interval estimate or analysis for the endpoint. Thus, the observed count is available, but the precision of an estimated positivity rate is not reported in the registry record. The endpoint should be interpreted as a descriptive count in the enrolled group rather than as a complete diagnostic-accuracy assessment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted result is straightforward: all 30 peripheral serum specimens tested positive for pregnancy. The registry describes these as specimens from women with previously confirmed pregnancies, tested once at enrollment. This establishes what was observed in the stated group; it does not establish how the test would perform in a broader population or in a comparison with another testing method.
There is no comparator arm in the record, so the result cannot be expressed as a difference between test strategies. The record also does not report a reference-test comparison, a cross-tabulation of test results against pregnancy status, or an interval estimate. Without such information, readers cannot judge statistical precision from the posted result alone. The number of positive specimens describes the observed data, while an estimate of performance beyond those participants would require additional analysis and assumptions.
The fact that the participants had previously confirmed pregnancies is important. A positive test among known pregnant participants addresses positivity in that selected group. It does not address false-positive results among people who are not pregnant. Nor does the outcome report how pregnancy confirmation was established, how long before the POC test it occurred, or whether the same reference method was used consistently. These details are not reported in the registry record.
The result should not be read as proof that every future specimen will test positive, or as evidence that the test is equivalent to another method. A finite set of observed results can be described exactly, but generalization requires consideration of how participants were selected, how the test was performed, and how uncertainty was quantified. Those design and analysis details are not reported in the registry record.
The registry lists no analyses. It therefore does not provide an inferential estimate, a confidence interval, or a statistical test for the endpoint. No estimate of sensitivity, specificity, predictive value, or agreement is reported. Such measures require information beyond the positive count in a group of known pregnancies, particularly results among people without pregnancy and a clearly described reference standard.
The study is marked completed and has a stated primary completion date, but completion status does not change the scope of the result. The reported finding remains a descriptive observation from the enrolled group. It can be useful as a record of the test outcomes obtained in that setting, while questions about diagnostic accuracy, precision, reproducibility, and performance in other populations remain open.
9. Statistical Methods Explained
What does a count endpoint represent? The primary outcome is a count of participants with a positive result. The underlying response is binary: a specimen is classified as positive or negative, and the count records the positive classifications. The registry reports all 30 tested peripheral serum specimens as positive. This is a descriptive summary of the observations, not a model-based estimate of performance in a wider population.
How would uncertainty usually be described? In general, a confidence interval expresses the range of values compatible with the observed data under a specified statistical model. It helps distinguish the observed result from the uncertainty around a population quantity that the study aims to estimate. The width of an interval depends on the amount of information and the analysis assumptions. No confidence interval for the endpoint is reported in the registry record, so the precision of any population-level estimate cannot be evaluated from the registry result.
For a binary outcome in a single group, analysts may estimate the proportion of participants with a positive result and quantify uncertainty around that estimate. That kind of estimate would still refer to the population represented by the study and would not automatically answer whether the test distinguishes pregnancy from nonpregnancy. The registry does not report a proportion estimate, an interval, or the method used for an inferential analysis. The stated count should not be expanded into an unreported estimate.
Why does the study design matter? Comparative analyses require an appropriate comparison group or paired observations from a reference method. This record describes one POC serum pregnancy test arm and does not report a comparator. A comparison between testing approaches, or an assessment of agreement, is therefore not available in the registry record. The outcome description says participants had previously confirmed pregnancies, but details of the confirmation method are not stated. Without a documented reference procedure and its results, diagnostic accuracy measures cannot be interpreted from the positive count alone.
In general, sensitivity concerns positive results among people who truly have the condition, while specificity concerns negative results among people who do not. Estimating both requires information from the relevant groups and a way to establish the underlying status. This study’s reported outcome concerns known pregnancies; the registry does not report a nonpregnant group. It therefore does not provide the evidence needed to estimate specificity. Other measures, such as predictive values, also depend on the composition of the tested population and cannot be inferred from the reported count alone.
What does the analysis record say? The registry lists one outcome measure and no analyses. That means the result available for statistical interpretation is the reported positive count, rather than an adjusted estimate or a formal test of a hypothesis. The record does not identify an analysis population beyond the outcome description, specify a missing-data method, or state how any unusable tests would be handled. These methods are not reported in the registry record.
How should planning calculations be understood? In general, sample-size planning calculations describe what a future study might require under stated assumptions; they are not observed findings. The planning illustration associated with this record is described as based on the 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 described as a stated fraction of the observed effect. These assumptions do not establish that the trial itself used that design or that its enrollment was chosen using those calculations. The registry does not report a sample-size justification for the trial. Because this study is listed as a single-arm test evaluation, a hypothetical two-arm planning framework should not be mistaken for evidence that a second arm was conducted.
In general, planning based on an observed effect can be optimistic if the observed effect is unusually large or unstable. A planning calculation is conditional on its assumptions and does not show the probability that the completed study detected an effect. It should not be called observed power. The registry record does not report an interim analysis plan, stopping rule, or formal statistical analysis plan. Those elements should not be inferred from the completed status or from a planning illustration.
What can be concluded from the posted result? The result supports a factual statement about the tested specimens: all 30 were reported positive. Statistical methods can help quantify uncertainty or compare diagnostic approaches when the needed design and data are available, but they cannot supply missing comparison information. Since the record reports no analyses and no reference-test results, further conclusions about accuracy or comparative performance are not reported in the registry record.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| POC Serum Pregnancy Test Arm | 30 | 30 | 100.0% | 88.4% to 100.0% | 88.6% to 100.0% | 88.8% to 99.9% |
R code and output
arm <- c("POC Serum Pregnancy Test Arm")
n <- c(30)
events <- c(30)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM POC Serum Pregnancy Test Arm 30 30 100.0 88.4 100.0 88.6 100.0 88.8 99.911. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure: the number of participants with a positive POC serum pregnancy test. It lists no analyses. With one listed outcome, the record does not describe a set of multiple primary endpoints or a family of statistical tests, but it also does not report a multiplicity procedure. Whether additional outcomes or exploratory analyses were planned outside the registry record is not reported in the registry record.
The outcome description states that all 30 peripheral serum specimens tested positive. The registry does not explain whether any enrolled participants lacked a test result, whether specimens could be excluded, or how missing or invalid tests would be handled. It also does not report a missing-data analysis. The stated population describes the tested specimens; further details about the relation between enrollment, specimen availability, and analysis inclusion are not reported in the registry record.
The record does not name an intention-to-treat, per-protocol, or other analysis population. It also does not describe exclusions after enrollment or protocol deviations. The outcome wording refers to all 30 peripheral serum specimens tested, but it does not provide a detailed participant flow or eligibility accounting. Consequently, readers cannot assess whether the analyzed set differed from the enrolled group for any reason.
No adjustment for covariates, subgroup analysis, or sensitivity analysis is reported. No analysis plan is listed. These omissions limit the ability to assess how the endpoint was selected, how incomplete data were treated, and whether the reported count was the only analysis performed.
12. 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 |
|---|---|---|---|
| POC Serum Pregnancy Test Arm | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| POC Serum Pregnancy Test Arm | 0 of 30 |
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 |
|---|---|
| POC Serum Pregnancy Test Arm | 0 of 30 |
The adverse-event record lists 30 participants at risk for serious adverse events and zero participants affected. It also lists 30 participants at risk for other adverse events and zero affected. Deaths are recorded as zero, and no serious adverse-event terms are listed.
These entries describe the safety data recorded for the POC serum pregnancy test arm. A zero count means that no affected participants are recorded in those fields; it does not establish that an event is impossible or that the intervention has no risk. Safety interpretation depends on how events were defined, collected, reviewed, and reported. Those details, including the observation period for adverse events and the method of ascertainment, are not reported in the registry record.
The study is a single-arm test evaluation, so the adverse-event figures do not provide a comparative safety estimate. The record does not identify a control group or report a comparison of event rates between groups. The counts should therefore be read as registry-reported observations for the listed arm, not as evidence of a difference in safety between approaches.
13. What the Result Does, and Does Not, Mean
The result establishes that the registry reports positive POC serum pregnancy test results for all 30 peripheral serum specimens tested in women with previously confirmed pregnancies. The test was described as a one-time assessment at enrollment. This finding is the central observation available for the primary endpoint.
It does not establish diagnostic accuracy across all people who might seek pregnancy testing. The record does not describe a nonpregnant comparison group, a reference-test result for each participant, or an estimate of sensitivity or specificity. It therefore cannot quantify false-positive results or show how closely the POC test agrees with another method. The result also does not establish that the same findings would occur in other settings, populations, or testing conditions.
The registry reports no analyses or interval estimates. The observed count can be stated, but the precision of a population-level estimate is not reported in the registry record. The record also does not describe recruitment, detailed eligibility criteria, test failures, missing results, or a statistical analysis plan. These omissions leave uncertainty about how broadly the finding can be applied and how the result would be evaluated under a prespecified inferential framework.
The study’s completed status is a record of trial status, not an independent measure of evidence strength. Likewise, a positive result in the enrolled group should not be interpreted as proof of equivalence to another testing approach or as a claim about clinical outcomes. The posted data are best understood as a descriptive account of test results in a group already known to be pregnant, with comparative and broader diagnostic questions unresolved.
14. Why This Trial Matters Statistically
This study illustrates why a clear definition of the target question matters in diagnostic research. A positive result among participants with previously confirmed pregnancies addresses whether the test returned positive in that selected group. It does not, by itself, address performance among people without pregnancy or distinguish the test’s contribution from the method used to establish pregnancy status.
The record also shows the difference between reporting an observed count and reporting an inferential analysis. All 30 specimens are reported positive, but the registry lists no analyses and no interval estimate. A count is useful for describing what happened in the tested group; estimates of precision and generalizability require an analysis plan and an account of the population represented.
Comparator design is central to claims about agreement or relative performance. This record lists a single test arm, so it does not support a direct comparison with another test. A documented reference method, results across relevant pregnancy-status groups, and transparent handling of missing or invalid tests would address questions that the stated outcome cannot resolve.
Statistically, the case is a reminder to separate the observed result from what a study can establish beyond its participants. The posted result is simple to read, while its scope is narrow. Understanding both points prevents a descriptive finding from being mistaken for a complete assessment of diagnostic performance.
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 registry describes one arm and does not report a comparator or randomized allocation. This limits interpretation to the observed outcomes in the POC serum pregnancy test arm and prevents a direct comparison with another test or method.
All participants in the outcome description had previously confirmed pregnancies. No nonpregnant group is reported, so the outcome does not address positive test results in people without pregnancy. The method used to confirm pregnancy before testing is not reported in the registry record, and no paired reference-test results are provided. These gaps prevent assessment of agreement or a full diagnostic-accuracy profile.
The record reports a count but no inferential analyses or confidence interval. It does not state how participants were recruited, give detailed eligibility criteria, or explain how invalid, failed, or missing test results would be handled. A participant-flow account and a detailed analysis population are not reported in the registry record.
The endpoint is described as a one-time test at enrollment. The registry does not report repeat testing, reproducibility, operator training, test-reading procedures, or whether results were interpreted without knowledge of prior pregnancy status. Such procedural details are not reported in the registry record.
The completed status and the reported positive results do not resolve these limitations. The study provides a descriptive observation in its stated group, but the registry record does not establish the result’s precision, comparative performance, or applicability beyond that group.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Efficacy Evaluation of Using Finger Stick Peripheral Blood for Point of Care Pregnancy Testing — NCT06747598.
- Registry record last updated 2026-05-12; status last verified 2025-03.
- Results first posted 2026-05-12.
- 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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19. Record Summary
The University of Nebraska-sponsored study, NCT06747598, is listed as completed. Its start date is 2025-02-26, its primary completion date is 2025-08-01, and enrollment is listed as 30. The study evaluates point-of-care pregnancy testing using a peripheral serum specimen collected through a finger stick.
The primary outcome is the number of participants with a positive POC serum pregnancy test at a one-time test at enrollment. The outcome description states that all 30 tested peripheral serum specimens from women with previously confirmed pregnancies were positive. The registry lists one outcome measure and no analyses.
One test arm is described; no comparator is reported. The registry does not report a reference-test comparison, an interval estimate, or a detailed statistical analysis plan. Safety fields list zero affected participants for serious and other adverse events and zero deaths.