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 Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women (NCT01282710), a registered phase not stated study. The primary outcome is Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01282710 |
| Phase | Phase not stated |
| Condition | Pregnancy - Labor Monitoring |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Reproductive Research Technologies, LP |
| Results posted | Yes |
2. Clinical Question
The study asks how contraction timing measured by SureCALL® EMG Labor Monitor® and by a tocodynamometer compares with timing measured by an intrauterine pressure catheter (IUPC). The registry describes the IUPC as the gold standard for the comparison. It also says the SureCALL® and tocodynamometer measurements were compared with each other.
Population
Pregnant women in labor. The registry lists an enrollment of 20 and describes the group as Pregnant, In Labor.
Intervention
Contraction-event timing measured with the SureCALL® EMG Labor Monitor®.
Comparator
The tocodynamometer is the predicate device. IUPC measurements serve as the stated gold-standard reference for the timing comparisons.
Primary question
How do the timing measurements from SureCALL® and the tocodynamometer compare with IUPC timing, and how do the two non-IUPC measurements compare with each other?
This is a measurement question, not a question about treatment assignment or clinical outcomes. The registry does not report a treatment effect or a patient outcome. It also does not provide numerical agreement or difference results, so the size and precision of any observed measurement differences cannot be described from the registry record.
3. Trial Design
The registry identifies NCT01282710 as a completed study sponsored by Reproductive Research Technologies, LP. Enrollment was 20. The study began in 2008-08, and the primary completion date was 2008-12. The listed condition is Pregnancy - Labor Monitoring.
The study is described as evaluating SureCALL® against the predicate tocodynamometer, using IUPC performance as the gold standard. The primary outcome description says contraction timing from SureCALL® and the tocodynamometer was compared with contraction timing from the IUPC, and that SureCALL® and tocodynamometer timing were also compared. The outcome is continuous, expressed in seconds, and summarized as a mean with standard deviation. Its stated timeframe is 9 - 42 Minutes.
The registry lists a Pregnant, In Labor group, but does not provide a fuller arm description. It is not a randomized comparison; allocation is not stated, and the listed arms are not a like-for-like control comparison. The registry record does not report the measurement sequence, whether all participants underwent each measurement, how contraction events were paired, or the number of observations contributing to each comparison. These details matter for understanding whether measurements were obtained under comparable conditions and how repeated measurements within a participant were handled.
The record lists one outcome measure and two analyses, but the analysis details and numerical results are not reported in the registry record. A protocol, sample-size justification, and fuller statistical analysis plan are not reported in the registry record either.
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 | Pregnant, In Labor |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 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 | Pregnant, In Labor |
|---|---|---|
| Participants analysed | 20 | |
| Age, Categorical: <=18 years | Participants | 2 |
| Age, Categorical: Between 18 and 65 years | Participants | 18 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age Continuous | years | 24.85 (SD 4.38) |
| Sex: Female, Male: Female | Participants | 20 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, measured over 9 - 42 Minutes.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Seconds |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns contraction-event timing, measured in seconds. It compares timing recorded by SureCALL® and by a tocodynamometer with timing recorded by an IUPC, which the study description calls the gold standard. It also includes a direct comparison between the SureCALL® and tocodynamometer timing measurements. The registry states that the continuous endpoint is expressed as a mean with standard deviation, over a timeframe of 9 - 42 Minutes.
For a measurement study, comparison with a reference method can help describe whether an instrument’s readings track the readings used as the standard. Looking at mean timing can describe the average level of the measurements, while standard deviation describes their variability. These summaries alone do not establish how closely individual measurements agree: average differences can coexist with substantial variation among measurements. General statistical interpretation of agreement may also use paired differences, limits of agreement, correlation, or other methods, but the registry record does not identify which methods were used.
The outcome is relevant to the stated device-comparison objective because contraction timing is what the instruments are being compared on. However, numerical means, standard deviations, differences, and uncertainty estimates are not reported in the registry record. The endpoint definition is therefore available, but the magnitude and precision of the observed comparisons cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the intended comparison: contraction timing from SureCALL® and a tocodynamometer was evaluated against IUPC timing, with an additional comparison between SureCALL® and the tocodynamometer. The endpoint is continuous and measured in seconds, with a stated timeframe of 9 - 42 Minutes. The record lists an enrollment of 20 and reports that the study is completed.
Those details describe the question and study context, not the result. The numerical outcome values are not reported in the registry record. In particular, the record does not provide the means or standard deviations for the measurements, a mean difference between devices, an estimate of agreement, a confidence interval, or a p-value. It lists two analyses, but their estimates and methods are not reported in the registry record. Therefore, the direction, magnitude, and precision of the observed comparisons cannot be characterized.
In general, a mean difference can indicate whether one measurement method tends to give higher or lower values than another, while a confidence interval can show the uncertainty around an estimated difference. For measurement agreement, the spread of paired differences is also important: a small average difference does not by itself mean that individual readings are close. These are general considerations, not descriptions of results from this study.
Without the outcome estimates, it is not possible to say whether either device’s timing measurements were close to IUPC measurements, whether one device differed more than the other, or how uncertain such comparisons were. A p-value alone, if one were reported, would not establish agreement or practical importance; the estimate and its uncertainty would still be needed. No such p-value is reported in the registry record.
The enrollment of 20 should be read as the number enrolled, not automatically as the number of usable measurement pairs for every analysis. The number contributing data to each comparison, exclusions, and missing measurement handling are not reported in the registry record. Consequently, the denominator and data completeness for the endpoint cannot be established from the available information.
The registry describes the study as completed, but completion status does not fill in the missing outcome estimates. Its stated comparison framework can be understood, while its substantive statistical findings remain unavailable in the registry record.
9. Statistical Methods Explained
The registry identifies a continuous endpoint summarized as a mean and standard deviation. It describes two device comparisons against IUPC timing and a comparison between SureCALL® and the tocodynamometer. The record does not specify the statistical procedures used for the listed analyses or report their numerical results. The explanations below are general statistical context, not claims about methods actually used in this study.
What does a mean describe?
A mean is a measure of the average value in a set of observations. In this study’s endpoint, that value concerns contraction timing in seconds. A mean can help describe the central level of timing measurements, but by itself it does not show how much measurements vary or how close measurements from different devices are for individual events. Two devices can have similar average readings while differing substantially for particular events.
What does a standard deviation describe?
In general, standard deviation describes how dispersed observations are around their mean. A larger standard deviation indicates greater variability in the observations, while a smaller one indicates less variability. It is not the same as the uncertainty in an estimated mean. A standard error or confidence interval is generally used to describe uncertainty in an estimate, and neither is reported for this endpoint in the registry record.
Why do paired measurements matter?
When two devices measure the same event, the comparison can be based on paired readings: each reading from one device is matched to the reading for the same event from the other. In general, analyzing paired differences can account for the fact that two readings from the same event are related. An unpaired comparison instead treats observations as independent groups, which may not represent a within-event measurement comparison. The registry record does not report whether observations were paired, how events were matched, or which analysis was used.
Repeated events from the same participant can also be related. In general, treating every event as independent when events are clustered within participants can understate uncertainty. Methods that account for participant-level clustering may be appropriate when repeated observations are present. The registry record does not report the number of contraction events, the number of observations per participant, or whether clustering was addressed, so the analysis structure cannot be determined.
What does agreement mean?
In general, agreement asks how close measurements from two methods are, rather than merely whether they move together. Correlation can describe how measurements vary together, but high correlation does not guarantee close agreement: one method could consistently read higher than another and still track its changes. A mean paired difference can describe average bias, while the spread of paired differences describes how individual readings differ. Limits of agreement are one general approach to describing that spread. These are possible concepts for a device-comparison study; the registry record does not say whether any of them were used.
Comparison with a reference method also does not make the reference error-free. The registry calls IUPC the gold standard, but the record does not provide information about reference-method measurement error or how uncertainty in IUPC readings was handled. Thus, any comparison should be understood as comparison with the stated reference, not as proof that the reference gives errorless measurements.
How should uncertainty be read?
In general, a confidence interval gives a range of values compatible with the data and analysis under its assumptions. A narrow interval indicates greater statistical precision than a wide interval, though precision is distinct from whether a difference is important for the intended use. The registry record does not report confidence intervals, standard errors, or other uncertainty measures for the endpoint. The precision of the device comparisons therefore cannot be assessed.
A p-value, in general, addresses how compatible data are with a specified null model under the analysis assumptions. It does not measure the size of a difference, quantify agreement, or establish practical importance. The registry record does not report p-values or identify a null hypothesis for the listed analyses.
What role does sample-size planning play?
The registry describes a planning illustration 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. This is a planning framework, not evidence about the study’s observed precision. Numerical planning results and the effect estimate used for them are not reported in the registry record. Such illustrations are not observed power and cannot replace the actual estimate and uncertainty from the study.
In general, planning calculations depend on assumptions about the target effect, variability, allocation, and analysis. A calculation based on an observed effect can be especially difficult to interpret as an independent justification, because the observed effect itself is uncertain. The registry record does not report the original design assumptions or sample-size justification, so the planning illustration should not be treated as the study’s documented prospective design.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and two analyses. It does not report what those analyses were, whether they address separate device comparisons or alternative analytic approaches, or which analysis was designated as primary. The protocol and a fuller statistical analysis plan are not reported in the registry record.
Multiplicity arises when several hypotheses or outcomes are tested. In general, conducting multiple tests can increase the chance of obtaining at least one apparently unusual result under a collection of null hypotheses. Statistical plans may address this by defining a primary comparison, adjusting inference, or treating some analyses as exploratory. The registry record does not report whether multiplicity was considered or whether any adjustment was used. Since numerical test results are also absent, it is not possible to assess how the two listed analyses affect interpretation.
Missing-data information is likewise limited. The enrollment is 20, but the number with usable measurements for each device comparison is not reported in the registry record. The record does not describe missing observations, withdrawals, exclusions, incomplete measurement pairs, or any imputation or other missing-data method. Enrollment therefore should not be assumed to equal the analysis population for every endpoint.
The record does not identify an analysis population, such as all enrolled participants or participants with complete paired measurements. It also does not report how any participant-level or event-level data were handled. These omissions matter because the analyzed set and treatment of incomplete measurements can affect estimates and their uncertainty. No specific missingness mechanism or analysis choice can be inferred from the registry record.
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 |
|---|---|---|---|
| Pregnant, In Labor | 0 | 20 | 0.0% |
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 |
|---|---|
| Pregnant, In Labor | 0 of 20 |
For the Pregnant, In Labor group, the registry lists 20 participants at risk and 0 affected for serious adverse events. It also lists 20 at risk and 0 affected for other adverse events. The death count is not reported in the registry record. No serious adverse-event terms are listed.
These figures describe the entries in the registry, not a complete safety assessment. In general, a count of zero affected means no events were recorded in that category for the listed group; it does not by itself establish that no events occurred outside the reported collection or observation period. The registry does not provide further information about adverse-event definitions, monitoring, observation duration, or completeness of reporting.
The safety entries do not describe the contraction-timing comparisons and should not be used to infer measurement agreement. Because the record lists a single group rather than a like-for-like control comparison, these counts also do not provide a comparative estimate of adverse-event risk. The registry record does not report enough detail to interpret the safety findings beyond the stated counts and denominators.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed study of contraction timing measurements in pregnant women in labor. It identifies SureCALL® and a tocodynamometer as the devices being compared, and IUPC as the stated gold-standard reference. It defines a continuous endpoint in seconds, summarized as a mean with standard deviation, over a timeframe of 9 - 42 Minutes. The enrollment was 20.
What the record does not establish is the size or direction of the device comparisons. The numerical means, standard deviations, estimated differences, and uncertainty measures are not reported in the registry record. It is therefore not possible to determine from this record how closely the readings agreed, whether one device tended to record different timing from another, or how precise any comparison was. The record also does not identify the analytic methods used for the two listed analyses.
In general, a measurement comparison is not settled by similar averages alone. Individual-level agreement, variability, and uncertainty can all matter. Likewise, a statistical test, if available, would not by itself answer whether measurements were sufficiently close for a particular purpose. These are general principles and do not imply any specific finding in this study.
The registry entry also does not describe a randomized treatment comparison, and its group descriptions are not a like-for-like control comparison. Thus, this record should be read as a device-measurement study description, not as evidence about a treatment effect. It does not report patient outcomes or establish that use of one device changes clinical outcomes.
The result is best understood as an incompletely reported measurement comparison: the devices, reference method, population, endpoint, and enrollment are identified, but the numerical findings needed to judge performance are not reported in the registry record.
13. Why This Trial Matters Statistically
Measurement studies address a distinct statistical problem from trials that compare treatments. Their central question is whether methods produce measurements that are sufficiently similar for the intended comparison, not whether an intervention changes a patient outcome. This study’s stated question is therefore about contraction-event timing from SureCALL® and a tocodynamometer relative to IUPC timing.
Statistically, the choice of comparison matters. Means and standard deviations describe average level and variability, but agreement between methods generally requires attention to paired differences and their spread. If repeated events are recorded within participants, dependence among observations may also matter. These considerations are general; the registry record does not report which agreement or repeated-measure methods were used.
The registry identifies the outcome and reference method, which makes the intended measurement question clear. It also gives an enrollment of 20 and lists two analyses. Yet the numerical estimates and uncertainty are not reported in the registry record. This distinction is important: a clearly stated question and completed study do not, by themselves, permit readers to evaluate the magnitude or precision of a measurement comparison.
The record also illustrates why analysis populations and missing measurements matter in device studies. A participant count does not reveal how many paired events were available, whether all participants contributed to each device comparison, or how repeated measurements were analyzed. Those details are not reported in the registry record.
For biostatisticians and clinical researchers, the study is a useful reminder to distinguish the definition of an endpoint from its results, and association from agreement. Without the numerical findings and methods, the registry entry documents the comparison’s intended structure but does not allow a statistical judgment of device performance.
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.
The main trial-specific limitation in interpreting this registry entry is that the primary endpoint’s numerical results are not reported in the registry record. Means, standard deviations, comparison estimates, and measures of uncertainty are unavailable. Although the record lists two analyses, their methods and outputs are not described. This prevents assessment of the magnitude, direction, and precision of the device comparisons.
The record gives an enrollment of 20 but does not report how many participants or contraction events contributed to each analysis. It does not describe whether the device measurements were paired for the same events, how events were identified or matched, whether participants contributed repeated observations, or how within-participant dependence was handled. These details are specific to interpreting a measurement comparison.
The listed group is Pregnant, In Labor, with no fuller arm description. The record states that this is not a randomized comparison, that allocation is not stated, and that the arms are not a like-for-like control comparison. The measurement sequence and conditions are not reported. As a result, the registry entry does not establish whether device measurements were collected under comparable conditions.
The protocol, prospective sample-size justification, fuller statistical analysis plan, missing-data approach, analysis population, and multiplicity handling are not reported in the registry record. The planning framework is described, but its numerical illustrations and underlying observed effect are not given. These omissions limit evaluation of how planned methods relate to reported analyses.
The safety record lists no affected participants in the reported serious and other adverse-event categories, but event definitions, monitoring duration, and reporting completeness are not described. These limitations do not establish that the study had a particular flaw; they describe what cannot be determined from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women — NCT01282710.
- Registry record last updated 2011-03-15; status last verified 2011-02.
- Results first posted 2011-03-15.
- 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
NCT01282710 is a completed measurement study sponsored by Reproductive Research Technologies, LP, with enrollment of 20. The listed population is pregnant women in labor. The study compares contraction timing measured by SureCALL® and a tocodynamometer with IUPC timing, and also compares the two non-IUPC measurements. The continuous endpoint is expressed in seconds, summarized as a mean with standard deviation, with a timeframe of 9 - 42 Minutes.
The registry lists one outcome measure and two analyses, but their numerical results and analysis details are not reported in the registry record. It also does not report the analysis population, missing-data handling, or fuller statistical plan. The entry defines the measurement question and study context, but does not provide the estimates needed to assess the direction, magnitude, or precision of device agreement.