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 Modifying Cervical Bishop Scoring System (NCT02314260), a registered phase not stated study. The primary outcome is Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02314260 |
| Phase | Phase not stated |
| Condition | Failed Induction of Labor |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 80 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Kasr El Aini Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The record describes 80 primigravidas undergoing Bishop score calculation, trans-vaginal ultrasound assessment of cervical length, and modified Bishop score calculation before labour induction at the hospital. The brief summary also refers to patients undergoing elective termination of pregnancy. Further eligibility details, including age range and other inclusion or exclusion criteria, are not reported in the registry record.
Intervention
The study procedures were calculation of the Bishop score, trans-vaginal ultrasound, and calculation of a modified Bishop score, followed by labour induction. These are assessments and a clinical procedure, rather than a randomized comparison of treatments. The registry does not describe the exact scoring modification or ultrasound measurement protocol.
Comparator
The stated objective is to compare the modified Bishop score's area under the ROC curve with the area for the Bishop score. The arm description reports assessments in the labour-induction group, but no separate control or comparison arm is described. The comparator's ROC area and a direct statistical comparison between the scores are not reported in the registry record.
Primary question
How well does the modified Bishop score distinguish cases of failed induction, including cases described as undergoing caesarean section, from other outcomes? The primary endpoint is the area under the ROC curve for the modified score. The intended purpose is prediction, not estimation of a treatment effect. The registry also lists cut-off values for both scores as secondary outcomes, but their results are not reported in the registry record.
3. Trial Design
The registry describes a completed study sponsored by Kasr El Aini Hospital, with enrollment of 80. The recorded start is 2014-07 and primary completion is 2014-12. The listed condition is failed induction of labor. The arm description identifies 80 primigravidas who underwent Bishop score calculation, trans-vaginal ultrasound assessment of cervical length, and modified Bishop score calculation before induction of labour at the hospital.
This is a prediction-assessment design as described in the record, not a randomized treatment comparison. No allocation method is stated, and no like-for-like control arm is described. The stated analysis aim is to assess the modified score's ROC area for predicting failed induction and compare it with the ROC area for the Bishop score. The record does not report a separate comparison group or a direct test of the difference between those areas.
The primary endpoint timeframe is 5 months. Details about when the score measurements were taken relative to induction, how failed induction was defined operationally, how caesarean section was classified, and whether outcome assessment was blinded are not reported in the registry record. Nor are recruitment procedures, participant flow, or reasons for any exclusions reported in the registry record.
Four outcome measures and four analyses are recorded. The secondary outcomes include the area under the curve for the Bishop score and cut-off values for both the modified Bishop score and Bishop score. Their numerical results are not reported in the registry record. The record does not describe a sample-size justification for the trial or a statistical analysis plan, so the design rationale and planned analysis details beyond the stated endpoint are not established by this entry.
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 | Labour Induction |
|---|---|
| STARTED | 80 |
| COMPLETED | 80 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: the area under the modified bishop score was 0.916 (95% \[confidence interval \] 0.85-0.97). The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).
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.
Population: 80 primigravidas undergoing induction of labour at our hospital
| Characteristic | Unit | Labour Induction |
|---|---|---|
| Participants analysed | 80 | |
| Age, Continuous | years | 24.31 (SD 3.65) |
| Sex: Female, Male: Female | Participants | 80 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: Egypt | participants | 80 |
| Gestational Age | Weeks | 39.70 (SD 1.50) |
| Bishop Score | units on a scale | 5.71 (SD 1.20) |
| Cervical Length | Cm | 2.06 (SD 0.56) |
| New Modified Bishop Score | units on a scale | 5.28 (SD 1.88) |
| Time to active Phase | Hours | 11.87 (SD 3.25) |
| Induction to delivery time | Hours | 17.38 (SD 4.29) |
| rupture of membraned duration | hours | 9.93 (SD 4.50) |
| Fetal weight (kilograms) | kilograms | 3.02 (SD 0.267) |
| Apgar score at 5 minutes | units on a scale | 8.45 (SD 1.82) |
6. Primary Endpoint
The registry lists the primary outcome as Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score, measured over 5 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | probability |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the receiver operating characteristic curve (ROC) for the modified Bishop score. An ROC curve evaluates how a score distinguishes people with a specified outcome across possible thresholds. In this study's description, the positive actual state is failed induction and performing caesarean section; sensitivity is plotted against the false-positive rate, defined in the record as 100 minus specificity.
As a general statistical explanation, the area under the curve reflects how well a score ranks participants with the outcome differently from those without it across thresholds. It summarizes discrimination without selecting a single cut-off. It does not by itself identify a clinically appropriate cut-off, indicate how well predicted probabilities are calibrated, or establish that using the score improves decisions.
The reported area is 0.916, with a 95% confidence interval of 0.85-0.97. The stated reason for using this endpoint is to assess prediction and compare the modified score with the Bishop score. The Bishop score's area and a formal comparison are not reported in the registry record. The precise outcome definition, including the relationship between failed induction and caesarean section, is not further specified in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports an ROC area of 0.916 for the modified Bishop score, with a 95% confidence interval of 0.85-0.97. As a general interpretation, a larger ROC area indicates better ability to rank participants with the target outcome above those without it across possible score thresholds. The point estimate therefore indicates substantial discrimination in the analyzed data, while the interval conveys uncertainty around that estimate. It does not establish the score's performance in other settings or populations.
The confidence interval is not a range containing the result for every participant, nor does it show the likely value for a particular patient. It describes uncertainty in the estimated ROC area under the analysis assumptions. The registry does not report the method used to calculate the interval, the number of participants included in the ROC analysis, or the numbers of participants with and without the outcome. Those omissions limit independent assessment of precision and of the analysis population.
The stated purpose includes comparing the modified score with the Bishop score. However, the Bishop score's ROC area, the difference between the two areas, and a statistical test or confidence interval for that difference are not reported in the registry record. The reported modified-score estimate alone cannot establish that it performs better than the original score. The listed secondary outcomes include cut-off values for both scores, but their numerical results and associated operating characteristics are not reported in the registry record.
The endpoint is a measure of discrimination, not a measure of treatment benefit or harm. It does not show whether induction is more successful, whether caesarean section is reduced, or whether using the score changes clinical outcomes. It also does not give the sensitivity or specificity at a chosen threshold, the consequences of false-positive or false-negative classifications, or calibration of predicted risk. Those quantities are not reported in the registry record.
The record describes 80 primigravidas assessed before labour induction in one hospital arm. With no separate control group reported, this is not a randomized comparison. The finding is specific to the analyzed participants and setting as described; external validation, performance in other groups, and the stability of the estimate over time are not reported in the registry record. The ROC area is informative about ranking in the study data, but the registry entry does not contain enough detail to judge whether the estimate is independently reproducible or directly actionable.
9. Statistical Methods Explained
The primary analysis uses an ROC area to describe prediction by the modified Bishop score. The record describes failed induction and performing caesarean section as the positive actual state. ROC analysis considers the relationship between sensitivity and the false-positive rate across score thresholds. Sensitivity is the true-positive rate, while the false-positive rate is 100 minus specificity, according to the endpoint description. The resulting curve describes classification trade-offs as the threshold changes.
What does the ROC area tell us?
As a general statistical explanation, the area under an ROC curve summarizes discrimination across thresholds rather than performance at one selected cut-off. A score with greater discrimination tends to rank participants with the target outcome higher than participants without it. The reported area for the modified Bishop score is 0.916. This is a summary measure; it does not provide the sensitivity and specificity at any particular threshold, nor does it state the number of false classifications that would follow from choosing a threshold.
The ROC area also does not assess calibration. Calibration concerns agreement between predicted risks and observed outcome frequencies, while an ROC area concerns ranking. The registry record does not report predicted probabilities, calibration analyses, or threshold-specific performance. The listed secondary outcomes include cut-off values for the modified score and the Bishop score, but their numerical results are not reported in the registry record.
How should the confidence interval be read?
The reported 95% confidence interval for the modified-score ROC area is 0.85-0.97. In general, a confidence interval expresses statistical uncertainty around an estimated quantity under the method's assumptions. The interval gives a range of values compatible with the observed estimate and analysis approach; it is not an assurance about any individual's outcome. The method used to calculate this interval, including whether it accounts for any relevant features of the data, is not reported in the registry record.
The interval applies to the modified-score ROC area. It does not quantify uncertainty in a comparison with the Bishop score. No numerical Bishop-score ROC area, between-score difference, or interval for that difference is reported in the registry record. Therefore, the primary estimate cannot by itself answer the stated comparative question.
What is not described about the analysis?
The record lists four outcome measures and four analyses, but it does not report a detailed analysis plan, analysis population, handling of missing outcome or score data, or participant flow into each analysis. The exact definition and ascertainment process for failed induction are not described beyond the endpoint wording. The registry also does not report whether score assessors or outcome assessors were blinded, how score measurements were recorded, or how ties in scores were handled. These details can affect interpretation of a prediction analysis, but their presence or absence in the study conduct cannot be inferred from this entry.
No statistical test for the comparative ROC question is reported. There is no reported multiplicity adjustment or hierarchy for the primary and secondary outcomes. There is also no reported interim analysis. These omissions mean the registry record does not establish how the analyses were selected, whether all planned analyses were reported, or how uncertainty was handled across the outcome measures.
How should planning illustrations be distinguished from trial results?
General sample-size illustrations are 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. For time-to-event calculations, the illustration concerns the total number of events; other calculations concern participants per arm. These are planning assumptions, not evidence that the study used those assumptions when it was designed. The trial's own sample-size justification is not reported in the registry record.
Such illustrations are not observed power. They describe planning quantities under assumed design conditions; they do not measure the probability that the completed study detected an effect. The equal-allocation, two-arm framing also does not match the arm description, which reports assessments and induction in one group and no like-for-like control arm. Numerical planning results are not reported in the registry record. No observed effect for a treatment comparison is described, and the ROC area should not be treated as a treatment effect.
Over-dispersion is a general concern when count data vary more than a chosen model expects: standard errors can then be too small if the extra variation is ignored. The primary outcome is an ROC area, not a count outcome, and the registry record does not describe a count model or an over-dispersion adjustment. More generally, the analysis methods needed to assess assumptions and reproduce the endpoint estimate are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists four outcome measures and four analyses. The primary outcome is the modified Bishop score's ROC area; the listed secondary outcomes concern the Bishop score's ROC area and cut-off values for both scores. The numerical results for those secondary outcomes are not reported in the registry record. The relationship between the four recorded analyses and the outcome measures is not explained in detail.
When several outcomes or analyses are examined, general statistical practice considers whether the chance of a false-positive finding is controlled through a prespecified hierarchy or an adjustment. The registry record does not report a multiplicity strategy, a testing hierarchy, or whether any adjustment was used. It also does not report whether the primary endpoint and analyses were prespecified in a protocol or analysis plan. This makes it difficult to assess how the reported primary result relates to the full set of analyses.
Missing-data handling and analysis populations are not reported in the registry record. The entry does not state how many participants contributed to the ROC analysis, whether every enrolled participant had complete score and outcome information, how missing measurements were handled, or whether any participants were excluded from an analysis. No participant-flow details or reasons for exclusions are reported.
These are reporting limitations, not proof that particular methods were or were not used. Without those details, readers cannot determine whether the reported estimate reflects all enrolled participants, how sensitive it may be to missing data, or whether analyses beyond the primary result alter the overall interpretation.
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 |
|---|---|---|---|
| Labour Induction | 18 | 80 | 22.5% |
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 |
|---|---|
| Labour Induction | 0 of 80 |
Most frequent serious adverse event terms
| Event term | Organ system | Labour Induction |
|---|---|---|
| failed labour induction | Pregnancy, puerperium and perinatal conditions | 18 of 80 |
Serious events with the highest arm-level rate: failed labour induction (22.5%).
For the Labour Induction group, the registry lists 80 at risk, 18 under serious adverse events, and 0 under other adverse events. The most frequent serious term is recorded as “failed labour induction” at 22.5%. These are registry safety figures and should be read as reported, not as an estimate of causal risk attributable to any one assessment or procedure.
The entry does not provide further detail about event definitions, severity grading, timing, relatedness assessments, or how the serious-event count corresponds to the listed term. It also does not explain whether the term represents participants, events, or another reporting unit. The 0 recorded under other adverse events does not establish that no such events occurred; it indicates that none are listed in that category in this record.
The group is described as undergoing induction and the score assessments, with no control group reported. Accordingly, these figures do not support a comparative safety estimate. The registry record does not report a causal analysis or a detailed accounting of adverse events by procedure.
12. What the Result Does, and Does Not, Mean
The primary posted result is a modified Bishop score ROC area of 0.916, with a 95% confidence interval of 0.85-0.97. In general, this statistic describes how well the score ranks participants with and without the stated outcome across possible thresholds. It is evidence about discrimination in the analyzed data, not a direct measure of treatment effect.
The result does not establish that the modified score is more accurate than the Bishop score. Although comparison is part of the stated aim, the Bishop score's ROC area and a formal comparison are not reported in the registry record. The listed cut-off outcomes also lack numerical results in the registry record, so no particular threshold or threshold-specific sensitivity and specificity can be described.
The estimate does not show that using the score prevents failed induction, reduces caesarean sections, or improves any other clinical outcome. It does not indicate whether decisions based on the score are beneficial, nor does it quantify the consequences of classification errors. Calibration, clinical utility, and performance in an independent population are not reported in the registry record.
The study description concerns 80 primigravidas assessed before labour induction at one hospital. No separate control arm or randomized allocation is described. The result should therefore be understood as an estimate of prediction performance in the study's described setting, with uncertainty reflected by the confidence interval. It is not, by itself, a basis for claims about other populations, settings, or clinical decisions.
13. Why This Trial Matters Statistically
This study addresses a practical statistical question: whether a score based on cervical assessment can distinguish participants more likely to experience failed induction. ROC analysis is useful for this kind of prediction question because it summarizes discrimination across thresholds rather than relying on a single cut-off. The reported modified-score area of 0.916, with a 95% confidence interval of 0.85-0.97, gives a compact estimate of that discrimination in the analyzed data.
The record also illustrates why a high-looking summary statistic is not the whole evaluation of a prediction tool. The intended comparison is with the Bishop score, but the comparator's ROC area and a formal difference estimate are not reported in the registry record. Without threshold-specific performance, calibration, or details of the outcome definition and analysis population, readers cannot determine how the score would perform at an actual decision threshold.
The study is described as a single group undergoing assessment and induction, rather than a randomized comparison. That structure can address prediction within the observed group, but it does not establish that using one score rather than another changes outcomes. The distinction between prediction and intervention effect is central to interpreting the result.
The registry entry also records four outcome measures and four analyses without describing multiplicity handling, missing-data methods, or a detailed analysis plan. These reporting gaps matter because clarity about outcomes and analysis choices helps readers judge reproducibility and uncertainty. The result is statistically informative as an ROC estimate, while important comparative and implementation questions remain unresolved in the registry record.
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 study-specific limitations evident from the registry record include the absence of a described control arm, allocation method, or direct comparator result. The stated aim compares the modified Bishop score with the Bishop score, but the latter's ROC area and a formal comparison are not reported in the registry record. As a result, the comparative claim cannot be evaluated from the posted primary result alone.
The record describes 80 primigravidas at one hospital, but does not report the number contributing to the primary analysis, participant flow, or exclusions. It does not provide details of the failed-induction definition, the timing and conduct of score assessments, or whether outcome assessment was blinded. The brief summary refers to elective termination of pregnancy, while the arm description specifies primigravidas undergoing labour induction; further clarification of the target population is not reported in the registry record.
Numerical results for the listed secondary outcomes, including cut-off values and the Bishop score area, are not reported in the registry record. Threshold-specific sensitivity and specificity, calibration, external validation, missing-data handling, and multiplicity procedures are also not reported. These gaps limit assessment of reproducibility, comparative accuracy, and generalizability.
The registry does not report a trial-specific sample-size justification or detailed statistical analysis plan. The described sample-size assumptions are planning illustrations and do not establish the design rationale for this study. These limitations concern the information available in the registry record; they do not establish what procedures may have been documented elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Modifying Cervical Bishop Scoring System — NCT02314260.
- Registry record last updated 2015-01-16; status last verified 2015-01.
- Results first posted 2015-01-16.
- 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
NCT02314260 is a completed study titled “Modifying Cervical Bishop Scoring System,” sponsored by Kasr El Aini Hospital. The recorded start is 2014-07, primary completion is 2014-12, and enrollment is 80. The arm description reports primigravidas assessed with the Bishop score, trans-vaginal ultrasound, and modified Bishop score before labour induction.
The primary endpoint is the ROC area for the modified Bishop score. The posted estimate is 0.916, with a 95% confidence interval of 0.85-0.97. The stated aim includes comparison with the Bishop score, but the comparator result and numerical results for listed secondary outcomes are not reported in the registry record. The entry does not describe a separate control arm, a detailed analysis plan, or missing-data handling.