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 Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor (NCT00308711), a randomized phase 3 study. The primary outcome is Minutes From Drug Insertion to Vaginal Delivery.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00308711 |
| Phase | Phase 3 |
| Condition | Cervical Ripening, Labor, Induced |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1308 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Ferring Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
The trial addressed cervical ripening and induction of labor in women requiring those procedures. Its central question was whether a misoprostol vaginal insert could safely and effectively speed the time to vaginal delivery compared with Cervidil. Two insert doses were studied, so the registry results include comparisons involving both misoprostol arms.
Population
Women requiring cervical ripening and induction of labor. The primary analysis concerned time to vaginal delivery; patients delivered by cesarean section were censored in that time-to-event analysis.
Intervention
Misoprostol vaginal inserts at 100 mcg and 50 mcg, each described as being used over 24h.
Comparator
Cervidil, a dinoprostone vaginal insert, at 10 mg over 24h.
Primary question
How long elapsed between insertion of the study drug and vaginal delivery, and how did the time-to-event results for the misoprostol arms compare with Cervidil?
The posted outcomes also cover labor and delivery processes, cervical ripening, hospital stay, and adverse events. Those measures add context but do not replace the primary question. The registry record does not report a more detailed eligibility description or a rationale for selecting the doses. It also does not report a formal hypothesis statement specifying how the two misoprostol comparisons were to be interpreted together.
3. Trial Design
The registry identifies this as a Phase III, randomized, parallel-group study with quadruple masking. The official title describes it as multi-center and double-blind. The listed interventions were misoprostol vaginal inserts at 100 mcg and 50 mcg, and a dinoprostone vaginal insert, Cervidil, at 10 mg. Each arm description specifies administration over 24h.
Enrollment is listed as 1308. The posted primary-endpoint results give arm-specific analysis counts of 426 for the 100 mcg insert, 440 for the 50 mcg insert, and 431 for Cervidil. These are analysis counts for the endpoint, not necessarily the randomized population in every analysis. The record does not explain the relationship between those counts and the enrollment figure, or give a detailed account of exclusions or missing observations.
The study status is completed. The registry lists a start of 2006-04 and primary completion of 2007-08. The sponsor is Ferring Pharmaceuticals. The primary endpoint is minutes from drug insertion to vaginal delivery, analyzed as a time-to-event outcome. The endpoint description gives 2880 minutes as the timeframe and notes that 48 hours can be used as an approximate interval by which most babies have been delivered; it also says there is no fixed assessment time because the event is birth.
Randomization and masking describe important features of the design, but the registry record does not report the sequence-generation method, allocation concealment procedures, or exactly which roles were included in quadruple masking. It does not report the protocol’s sample-size justification or a detailed statistical analysis plan. Those omissions limit how fully the design and the posted analyses can be independently assessed.
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 | Misoprostol Vaginal Insert (MVI) 100 | Misoprostol Vaginal Insert (MVI) 50 | Cervidil 10 mg Vaginal Insert |
|---|---|---|---|
| STARTED | 428 | 444 | 436 |
| COMPLETED | 426 | 440 | 431 |
| NOT COMPLETED | 2 | 4 | 5 |
Reasons for not completing this period:
| Reason | Misoprostol Vaginal Insert (MVI) 100 | Misoprostol Vaginal Insert (MVI) 50 | Cervidil 10 mg Vaginal Insert |
|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 1 |
| Protocol Violation | 0 | 1 | 1 |
| Lost to Follow-up | 0 | 1 | 0 |
| Baby not born within 7 days of treatment | 1 | 2 | 2 |
| Subject incarcerated, data not allowed | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate.
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 | Misoprostol Vaginal Insert (MVI) 100 | Misoprostol Vaginal Insert (MVI) 50 | Cervidil 10 mg Vaginal Insert | Total |
|---|---|---|---|---|---|
| Participants analysed | 428 | 444 | 436 | 1308 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 428 | 444 | 436 | 1308 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age Continuous | years | 26.2 (SD 5.9) | 26.9 (SD 6.2) | 26.0 (SD 5.7) | 26.4 (SD 5.9) |
| Sex: Female, Male: Female | Participants | 428 | 444 | 436 | 1308 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 413 | 427 | 419 | 1259 |
| Region of Enrollment: Canada | participants | 15 | 17 | 17 | 49 |
| Parity: Nulliparous | participants | 267 | 275 | 270 | 812 |
| Parity: Parous | participants | 161 | 169 | 166 | 496 |
| modified Bishop score (mBS) | Units on a scale of 0 (low) to 12 (most) | 2.69 (SD 1.1) | 2.74 (SD 1.1) | 2.73 (SD 1.1) | 2.72 (SD 1.1) |
6. Primary Endpoint
The registry lists the primary outcome as Minutes From Drug Insertion to Vaginal Delivery, measured over 2880 minutes.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | minutes |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint measures the interval, in minutes, from insertion of the study drug to the birth of the neonate by vaginal delivery. It is a time-to-event measure: the event is the birth itself, so the outcome is not tied to a single scheduled assessment. The registry describes 2880 minutes as the timeframe and says 48 hours is an approximate interval by which most babies have been delivered.
Time to vaginal delivery can retain information about both whether the event occurred within the observation period and how long it took. A median gives the time by which half of the estimated event distribution has occurred, while the 95% confidence interval expresses uncertainty around that estimate. This is general statistical interpretation, not a statement about an additional registry analysis.
The registry states that patients delivered by cesarean section were censored from this time-to-event analysis. Censoring means that a participant’s exact time to the event of interest is not treated as an observed vaginal-delivery time. The description says censoring used the longest interval for all participants, but its wording about the reference interval is incomplete in the registry record. The precise operational definition and any further handling of censoring are therefore not reported in the registry record.
This endpoint focuses specifically on vaginal delivery, rather than time to any mode of birth. Consequently, its interpretation depends in part on how cesarean deliveries and other incomplete event times were handled. The registry record does not provide enough detail to assess all assumptions behind that handling.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results give median times to vaginal delivery of 1596 minutes for the 100 mcg misoprostol insert, 2127 minutes for the 50 mcg insert, and 1650 minutes for Cervidil. The respective 95% confidence intervals are 1469 to 1739, 1977 to 2253, and 1509 to 1824 minutes. These estimates describe the observed time-to-event distributions; they are not, by themselves, proof of a causal difference between treatments.
For the comparison of the 100 mcg insert with Cervidil, the registry reports a log-rank analysis with a Kaplan-Meier parameter and p = 0.974. For the 50 mcg insert compared with Cervidil, it reports a log-rank analysis with a Cox proportional hazard parameter and p = 0.011. The latter output is presented as a value of 1977 with a 95% confidence interval of 1977 to 2253, rather than as a hazard ratio. The registry does not explain this output’s scale or give a hazard ratio, which limits interpretation of the reported comparison. The two reported analyses use different parameter labels, so their numerical outputs should not be treated as directly interchangeable.
The registry also posts secondary measures involving oxytocin use before delivery, cervical ripening success, and onset of active labor, among other outcomes. Unadjusted recalculations show a different pattern for the 50 mcg arm than for the 100 mcg arm on some of these measures. Comparisons of Cervidil with the 100 mcg arm do not show a clear statistical separation in the recalculated secondary results. These findings are secondary and unadjusted; they should not be read as independent confirmation of the primary result.
Confidence intervals convey precision as well as direction. A comparatively narrow interval indicates less uncertainty about the estimated value than a wider interval, while neither guarantees that the estimate is unbiased or clinically important. The endpoint confidence intervals are estimates for each arm; the registry does not report confidence intervals for the difference between the primary endpoint distributions.
The posted data support describing the arm-specific medians and the analyses recorded by the sponsor. They do not establish why the differences occurred, whether they reflect a particular biological mechanism, or how the results would generalize beyond the enrolled population. The registry record does not report a prespecified multiplicity strategy for the primary comparisons and secondary outcomes, so the p-values should be read with that qualification.
9. Statistical Methods Explained
The primary endpoint is a time-to-event outcome. In general, time-to-event methods account for the event time and for observations in which the event time is not fully observed. Kaplan-Meier estimation is a standard way to estimate the event-time distribution while incorporating censoring. A median from this distribution is the estimated time by which half of the event distribution has occurred. The posted median and its 95% confidence interval describe each arm’s estimate and uncertainty; they do not directly quantify the uncertainty in a between-arm difference.
How should censoring be understood?
In general, censoring occurs when the event of interest is not observed in the way required for the analysis, even though some follow-up information may exist. The registry says cesarean deliveries were censored for the vaginal-delivery analysis and refers to use of the longest interval for all participants. Because the endpoint description is incomplete at that point, the exact censoring value and its implementation are not fully reported in the registry record. Censoring methods also rely on assumptions about the relationship between censoring and the event process; the record does not report diagnostics or sensitivity analyses addressing those assumptions.
What do the reported tests mean?
The registry reports log-rank analyses for the primary comparisons. In general, a log-rank test assesses whether event-time distributions differ between groups over the observation period. A p-value measures how compatible the observed test result is with a specified null model under the test’s assumptions; it is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. The registry gives p = 0.974 for the 100 mcg insert versus Cervidil and p = 0.011 for the 50 mcg insert versus Cervidil.
The record labels the 100 mcg comparison as Kaplan-Meier and the 50 mcg comparison as Cox proportional hazard. In general, a Cox model estimates a relative event rate under a proportional-hazards assumption. The registry does not provide a hazard ratio for the posted 50 mcg comparison, and its listed value and interval are on a scale that is not explained in the record. A reader should therefore not infer a hazard ratio or its direction from those numbers alone. Proportional-hazards diagnostics and adjustment variables are not reported in the registry record.
What are the recalculated secondary comparisons?
The recalculated binary comparisons use risk differences: the difference between the proportion with an outcome in one arm and the proportion in the comparator arm. In general, a confidence interval around a risk difference communicates uncertainty in that difference, and a p-value assesses a null of no difference under the calculation’s assumptions. The posted recalculated p-values are unadjusted. They are simple comparisons based on posted summary statistics, not the sponsor’s complete analysis model.
For continuous outcomes, the recalculations use mean differences and confidence intervals based on posted group summaries. In general, means summarize the average and standard deviations describe spread around the mean. A mean difference is sensitive to the distribution and to how missing or censored observations are handled. The record does not report enough detail to determine whether the recalculated comparison reproduces the sponsor’s analysis population or any model adjustments.
Why can over-dispersion matter?
In general, over-dispersion means that observed variability is greater than a model assumes. If a model understates variability, standard errors can be too small and confidence intervals too narrow, making statistical evidence appear stronger than it is. The posted secondary recalculations use simple summary-statistic methods; the registry record does not report model checks or an over-dispersion assessment for these comparisons. This general point is relevant when considering whether a simple model adequately represents the outcome, but it is not evidence that over-dispersion occurred in this trial.
The sample-size illustrations are planning calculations based on observed effects, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrations consider stated fractions of the observed effect. In general, planning for a smaller effect requires more participants than planning for a larger effect, all else equal. These calculations are not observed power and do not reconstruct the trial’s original design assumptions. For time-to-event outcomes, the illustrations give a total number of events using the Schoenfeld method; the other illustrations give participants per arm. The protocol’s own sample-size justification is not reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Log Rank | Kaplan-Meier 1595.5 | not reported | 0.974 |
| Log Rank | Cox Proportional Hazard 1977 | 1977 to 2253 | 0.011 |
The registry’s own primary analyses are log-rank analyses: the comparison of the 100 mcg insert with Cervidil is labeled Kaplan-Meier and has p = 0.974, while the comparison of the 50 mcg insert with Cervidil is labeled Cox proportional hazard and has p = 0.011. The associated posted values are 1595.5 for the first comparison and 1977 for the second; the second has a 95% confidence interval of 1977 to 2253. The record does not explain the scale of the second output or report a hazard ratio.
The recalculations are unadjusted comparisons derived from posted summary statistics, and they are not substitutes for the sponsor’s time-to-event analyses. They do not reproduce the full handling of censoring or any analysis procedures that are not documented in the registry record. The record does not indicate a discrepancy between the posted data and the recalculated results. If a discrepancy were present, the sponsor’s own analysis would take precedence; no such discrepancy is identified in this record.
The sponsor’s reported p-values should be considered alongside the arm-specific median estimates and their confidence intervals, while recognizing that the analysis outputs are not reported in a fully comparable format. The registry record does not provide a complete statistical analysis plan, a detailed account of the model specification, or further explanation of the reported Cox result. Those gaps prevent a fuller appraisal of how the sponsor’s analysis relates to the underlying event-time data.
11. Multiplicity, Missing Data and Analysis Populations
The registry record does not report how multiplicity was addressed across the primary comparisons, secondary outcomes, and adverse-event evaluations. This matters because repeated testing can increase the chance of at least one small p-value under a collection of null hypotheses. In general, a prespecified testing hierarchy or adjustment procedure can help control that risk. Without one reported in the record, the secondary p-values are best treated as exploratory and the primary comparisons should be interpreted in light of the unreported testing strategy.
Missing-data handling is also not described in sufficient detail. For the primary endpoint, the record explicitly states that patients delivered by cesarean section were censored, but the endpoint description’s explanation of the censoring interval is incomplete. It does not report a full account of censoring rules, losses to follow-up, or sensitivity analyses. For the secondary outcomes, the registry record does not report the extent of missing data or how missing observations were handled.
Analysis populations are not fully characterized. The primary endpoint lists arm-specific analysis counts, but the record does not state whether those counts correspond to an intention-to-treat population, a per-protocol population, or another defined set. It does not report the analysis population used for each secondary endpoint. Randomization supports comparison at the design level, but interpretation also depends on who was included in each analysis and how departures from assigned treatment were handled; those details are not reported in the registry record.
The statistical analysis plan, interim analyses, and stopping rules are not reported in the registry record. These omissions should not be filled in by assumption. The posted analyses can be described as recorded, but the available information does not permit a complete assessment of prespecification, multiplicity control, or the effect of missing observations on the estimates.
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 |
|---|---|---|---|
| Misoprostol Vaginal Insert (MVI) 100 | 106 | 428 | 24.8% |
| Misoprostol Vaginal Insert (MVI) 50 | 134 | 443 | 30.2% |
| Cervidil 10 mg Vaginal Insert | 117 | 436 | 26.8% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2.0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Misoprostol Vaginal Insert (MVI) 100 | 130 of 428 |
| Misoprostol Vaginal Insert (MVI) 50 | 129 of 443 |
| Cervidil 10 mg Vaginal Insert | 132 of 436 |
Most frequent serious adverse event terms
| Event term | Organ system | Misoprostol Vaginal Insert (MVI) 100 | Misoprostol Vaginal Insert (MVI) 50 | Cervidil 10 mg Vaginal Insert |
|---|---|---|---|---|
| Foetal heart rate disorder | Pregnancy, puerperium and perinatal conditions | 46 of 428 | 47 of 443 | 35 of 436 |
| Arrested Labor | Pregnancy, puerperium and perinatal conditions | 25 of 428 | 36 of 443 | 33 of 436 |
| Cephalopelvic Disproportion | Pregnancy, puerperium and perinatal conditions | 14 of 428 | 35 of 443 | 29 of 436 |
| congenital anomaly | Congenital, familial and genetic disorders | 10 of 428 | 7 of 443 | 7 of 436 |
| ABO hemolytic disease of the newborn | Pregnancy, puerperium and perinatal conditions | 9 of 428 | 8 of 443 | 3 of 436 |
| hyperbilirubinemia neonatal | Hepatobiliary disorders | 6 of 428 | 5 of 443 | 8 of 436 |
| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | 4 of 428 | 3 of 443 | 6 of 436 |
| neonatal respiratory depression | Respiratory, thoracic and mediastinal disorders | 5 of 428 | 1 of 443 | 5 of 436 |
| postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | 1 of 428 | 4 of 443 | 4 of 436 |
| neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 2 of 428 | 3 of 443 | 4 of 436 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Misoprostol Vaginal Insert (MVI) 100 | Misoprostol Vaginal Insert (MVI) 50 | Cervidil 10 mg Vaginal Insert |
|---|---|---|---|---|
| Foetal heart rate disorder | Pregnancy, puerperium and perinatal conditions | 130 of 428 | 129 of 443 | 132 of 436 |
| uterine contractions abnormal | Pregnancy, puerperium and perinatal conditions | 83 of 428 | 61 of 443 | 81 of 436 |
| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | 38 of 428 | 45 of 443 | 44 of 436 |
| Perineal laceration | Pregnancy, puerperium and perinatal conditions | 21 of 428 | 28 of 443 | 21 of 436 |
| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | 17 of 428 | 30 of 443 | 22 of 436 |
| Anemia | Blood and lymphatic system disorders | 21 of 428 | 25 of 443 | 20 of 436 |
| Abnormal labour affecting foetus | Pregnancy, puerperium and perinatal conditions | 24 of 428 | 12 of 443 | 28 of 436 |
| Hypotension | Vascular disorders | 18 of 428 | 21 of 443 | 23 of 436 |
| uterine hypertonus | Pregnancy, puerperium and perinatal conditions | 17 of 428 | 16 of 443 | 25 of 436 |
| post partum hemorrhage | Pregnancy, puerperium and perinatal conditions | 17 of 428 | 16 of 443 | 21 of 436 |
Serious events with the highest arm-level rate: foetal heart rate disorder (10.7%), arrested labor (8.1%), cephalopelvic disproportion (7.9%), congenital anomaly (2.3%), abo hemolytic disease of the newborn (2.1%).
The registry posts serious and other adverse-event counts by arm. For serious adverse events, the listed affected counts are 106 among 428 at risk in the 100 mcg arm, 134 among 443 at risk in the 50 mcg arm, and 117 among 436 at risk in the Cervidil arm. For other adverse events, the listed counts are 130 among 428 at risk, 129 among 443 at risk, and 132 among 436 at risk, respectively. These are descriptive counts with the registry’s stated at-risk denominators; they are not adjusted comparisons.
The listed serious-event terms include foetal heart rate disorder at 10.7%, arrested labor at 8.1%, cephalopelvic disproportion at 7.9%, congenital anomaly at 2.3%, ABO hemolytic disease of the newborn at 2.1%, and neonatal hyperbilirubinemia at 1.8%. The registry does not identify an arm for these term percentages in the posted list, so they should not be assigned to a particular treatment group. Death counts are not reported in the registry record.
Adverse-event counts do not alone establish whether an event was caused by a study treatment, and the registry record does not provide a detailed comparative safety analysis or exposure-adjusted rates. These figures describe what was posted, not a clinical recommendation.
13. What the Result Does, and Does Not, Mean
The primary endpoint describes time from insertion of a study drug to vaginal delivery, with cesarean deliveries censored according to the registry’s stated approach. The arm-specific medians and confidence intervals summarize the observed event-time results. The sponsor’s reported log-rank p-values give evidence from two recorded comparisons, but their interpretation is constrained by incomplete reporting of the Cox output and analysis details.
These results do not establish that either treatment is clinically preferable, and they do not show why the observed event-time patterns occurred. Statistical significance is not the same as clinical importance. A p-value does not measure the size of a treatment effect, while a confidence interval does not account for every possible source of bias or uncertainty. Clinical interpretation would also require context about the participants, care practices, and trade-offs among outcomes; the registry record does not provide all of that context.
The primary analysis is specific to vaginal delivery and its censoring rules. It should not be interpreted as a measure of time to birth by any mode unless that is separately defined. Secondary outcomes broaden the description but are not a substitute for the primary endpoint, particularly because their multiplicity handling and analysis populations are not reported.
The trial record does not report a full protocol, prespecified analysis hierarchy, detailed missing-data procedures, or complete model diagnostics. Consequently, the posted results allow a statistical description of the recorded estimates and tests, but not a complete reconstruction of every analytic decision. The findings should be understood as evidence from this trial record, not as a universal estimate for every clinical setting.
14. Why This Trial Matters Statistically
This trial illustrates why an endpoint’s definition is central to statistical interpretation. Time from insertion to vaginal delivery is not simply a continuous measurement recorded at a fixed visit. It is a time-to-event outcome, and the registry’s treatment of cesarean deliveries as censored observations affects the analysis population and the meaning of the estimate. Clear reporting of the event definition and censoring rules is essential for readers to understand what a median represents.
It also illustrates the difference between an arm-specific summary and a comparative analysis. The posted medians and confidence intervals describe each arm, whereas a log-rank test evaluates evidence about event-time distributions. Neither should be mistaken for the other. In particular, an arm-specific confidence interval is not a confidence interval for the difference between arms.
The registry presents two sponsor analyses with different parameter labels and does not give a hazard ratio for the Cox-labeled comparison. This makes transparent reporting of model outputs and estimands especially important. A p-value without a clearly interpretable effect measure can be difficult to connect to the size and direction of a comparison.
Finally, the breadth of secondary outcomes raises the familiar issue of multiplicity. Secondary measures can add context, but unadjusted results across several outcomes need cautious interpretation. The case underscores how statistical conclusions depend not only on the numerical estimates, but also on prespecification, missing-data handling, analysis populations, and complete reporting—details that are not all available in the registry record.
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.
Several limitations are specific to the registry record. The primary endpoint description ends mid-sentence while explaining the longest interval used for censoring. Although the record states that cesarean deliveries were censored, it does not fully specify the reference interval or all implementation details. This limits independent assessment of the time-to-event analysis.
The sponsor’s reported comparisons are not presented in a common, fully interpretable effect format. One is labeled Kaplan-Meier and the other Cox proportional hazard; the latter’s posted value and confidence interval are not accompanied by a hazard ratio or an explanation of the scale. The registry record does not report model covariates, diagnostics, or the proportional-hazards assessment.
The record does not explain why the endpoint analysis counts differ from the enrollment figure, define the analysis population, or report how missing observations were handled for the primary and secondary outcomes. The protocol’s sample-size rationale and statistical analysis plan are also not reported. Thus, the posted planning illustrations should not be taken as evidence about the original design or as observed power.
Finally, the record does not report a multiplicity strategy, identify whether secondary analyses were prespecified, or provide arm attribution for the listed serious-event term percentages. These limitations do not invalidate the posted data, but they constrain how confidently readers can connect individual estimates to a broader confirmatory conclusion.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor — NCT00308711.
- Registry record last updated 2012-06-25; status last verified 2012-06.
- Results first posted 2010-02-19.
- 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 registry describes a completed, randomized, parallel-group Phase III study of misoprostol vaginal inserts at 100 mcg and 50 mcg compared with Cervidil 10 mg for women requiring cervical ripening and induction of labor. The official title describes a multi-center, double-blind study; the record lists quadruple masking.
The primary endpoint was minutes from drug insertion to vaginal delivery, analyzed as a time-to-event outcome. Posted median times were 1596 minutes for the 100 mcg arm, 2127 minutes for the 50 mcg arm, and 1650 minutes for Cervidil. The registry reports log-rank p-values of 0.974 and 0.011 for the respective comparisons with Cervidil, with incomplete detail for the Cox-labeled output.
Secondary outcomes address labor processes, cervical ripening, stay duration, and adverse events. Interpretation is limited by unreported multiplicity procedures, analysis populations, missing-data handling, and parts of the censoring and model descriptions.