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 Cervical Ripening in Premature Rupture of Membranes (NCT02314728), a randomized na study. The primary outcome is Rate of Cesarean Section.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02314728 |
| Phase | NA |
| Condition | Pregnancy, Premature Rupture of Membranes, Preterm Premature Rupture of Membranes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 230 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Montefiore Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Pregnant participants with premature rupture of membranes and an unfavorable cervix were the population of interest. The registry record describes PROM as rupture of the amniotic membrane before labor begins. It does not report detailed eligibility criteria, gestational-age limits, or participant characteristics for this trial.
Intervention
The intervention arm was misoprostol, described in the registry as vaginal PGE1 at a dose of 25mcg every 4 hours, according to hospital protocol.
Comparator
The comparator was oxytocin alone, administered as an infusion and titrated according to hospital protocol or until adequate contractions. The trial was randomized, open-label, and parallel-group.
Primary question
The primary endpoint was the rate of cesarean section, with mode of delivery assessed within 48 hours. The registry record does not provide the category-specific outcome counts needed to compare the arms on this endpoint.
The clinical question is whether the two induction approaches differ in cesarean delivery among participants with PROM and an unfavorable cervix. In the trial rationale, the concern is that the cervix may be unfavorable when labor has not begun, and that induction with oxytocin alone may be associated with cesarean delivery. The registry describes prior clinical context and the rationale for comparing a prostaglandin agent with oxytocin alone; those background statements are not findings from this randomized comparison.
The registry record lists maternal and neonatal infectious morbidity as a secondary outcome. It does not report outcome counts or a comparison for that outcome. Consequently, the posted information does not establish whether either induction approach was associated with a different cesarean rate or infection rate in this trial. The question is clinically framed, but the record does not contain the results needed to answer it statistically.
3. Trial Design
This was a randomized, parallel-group trial sponsored by Montefiore Medical Center. The registry lists an enrollment of 230 and a completed status. The recorded start date is 2014-10-01, and the primary completion date is 2016-05-30. The phase is listed as NA. The registry describes two treatment groups: misoprostol and oxytocin alone.
Random allocation is intended to create groups that are comparable, on average, with respect to measured and unmeasured characteristics before treatment. It does not guarantee that every characteristic will be balanced in a particular trial. The registry record does not describe the sequence-generation procedure, allocation concealment, stratification, or any other details of the randomization process. Those design features are therefore not reported in the registry record.
Masking is listed as none. This means the record does not describe the trial as blinded. The registry does not specify which individuals knew each participant’s assigned group, or whether outcome assessment was conducted by someone unaware of assignment. Knowledge of treatment can matter especially when outcomes involve clinical decisions or classification, although the endpoint is described as mode of delivery.
The misoprostol arm is described as receiving vaginal PGE1 at 25mcg every 4 hours according to hospital protocol. The oxytocin arm is described as receiving an infusion titrated according to hospital protocol or until adequate contractions. The record does not provide further protocol details, treatment duration, co-interventions, adherence, or criteria used to determine adequate contractions. These details are not reported in the registry record.
The registry lists two outcome measures and three analyses, but the analyses’ methods and results are not described in the record available for this interpretation. The primary outcome has multiple categories or time points and is not reduced to a single comparison. There is therefore no posted arm-level cesarean result or effect estimate to interpret. Enrollment is a trial-design figure; it is not, by itself, evidence about the outcome or the precision of a treatment comparison.
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.
Before assignment: Calculated Sample size of 208-104 per each arm. Recruited 230 women out of 294 admitted with PROM and assessed for eligibility.
Overall Study
| Stage | Vaginal Misoprostol | Oxytocin Alone |
|---|---|---|
| STARTED | 117 | 113 |
| COMPLETED | 116 | 112 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Vaginal Misoprostol | Oxytocin Alone |
|---|---|---|
| Protocol Violation | 1 | 0 |
| Lost to Follow-up | 0 | 1 |
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 | Vaginal Misoprostol | Oxytocin Alone | Total |
|---|---|---|---|---|
| Participants analysed | 116 | 112 | 228 | |
| Age, Categorical: <=18 years | Participants | 2 | 6 | 8 |
| Age, Categorical: Between 18 and 65 years | Participants | 114 | 106 | 220 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 25.5 (18 to 43) | 26 (16 to 45) | 26.0 (16 to 45) |
| Sex: Female, Male: Female | Participants | 116 | 112 | 228 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Caucasian | Participants | 10 | 9 | 19 |
| Race/Ethnicity, Customized: African American | Participants | 28 | 26 | 54 |
| Race/Ethnicity, Customized: Hispanic | Participants | 64 | 62 | 126 |
| Race/Ethnicity, Customized: Other | Participants | 14 | 15 | 29 |
| Region of Enrollment: United States | participants | 116 | 112 | 228 |
6. Primary Endpoint
The registry lists the primary outcome as Rate of Cesarean Section, measured over within 48 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled “Rate of Cesarean Section.” It is defined as mode of delivery via cesarean section or vaginal delivery, with a timeframe of within 48 hours. The registry identifies the measure as a participant count. This endpoint therefore concerns how participants delivered during the stated period, rather than a continuous measurement or a time-to-event estimate.
Mode of delivery is used as an outcome because it captures a consequential event in the course of labor and delivery and is directly relevant to the trial’s comparison of induction approaches. In a randomized trial, comparing the proportion or number of participants with each delivery mode could describe whether the observed outcomes differed between assigned groups. That general interpretation depends on having the category counts and a specified analysis; the posted record does not provide those counts in a form that supports a single comparison.
The endpoint title uses the word “rate,” but the description includes two categories: cesarean section and vaginal delivery. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. No cesarean count, vaginal-delivery count, effect estimate, confidence interval, or p-value for this endpoint is reported in the registry record. The endpoint is defined, but the trial’s primary outcome result cannot be quantified from the posted information.
The stated timeframe is within 48 hours. The record does not explain how outcomes outside that window would be handled or whether any participant lacked a recorded delivery mode. Such endpoint-handling details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of misoprostol with oxytocin alone and names cesarean section as the primary outcome. However, it does not report the group-specific cesarean and vaginal-delivery counts, an effect estimate, uncertainty interval, or statistical test result for this outcome. The record also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. Accordingly, there is no primary-outcome contrast in the posted information that can be interpreted as evidence for a difference between the randomized groups.
This absence is not the same as finding equal outcomes. A conclusion of equality or similarity would require results that estimate the difference and show how uncertain that estimate is, often with a prespecified equivalence or non-inferiority framework. The registry does not report such a framework or the necessary primary-outcome results. It would be inappropriate to infer that the approaches had the same outcome simply because a usable comparison is not present.
The adverse-event record lists 117 at risk in the misoprostol group and 113 at risk in the oxytocin-alone group. It reports zero serious events and zero other affected participants in each group, with zero deaths in each group. These are the adverse-event figures recorded for the two groups; they do not substitute for the missing delivery-mode outcomes. Nor do zero reported events demonstrate that risk is absent. Interpretation depends on how events were defined, collected, and reported, and those details are not reported in the registry record.
Maternal and neonatal infectious morbidity is listed as a secondary outcome, but no numerical result for it is present. The record reports three analyses, yet their content, statistical methods, and findings are not reported. It also does not describe missing outcome data, the analysis population, or adjustments for multiple outcomes. Without those details, the registry information cannot establish whether the study’s planned analyses were completed as intended or how any findings should be weighted.
The enrollment figure of 230 describes the trial’s recorded enrollment, not the number with a known primary outcome in each analysis. The adverse-event denominators should not be assumed to be the primary-outcome denominators. The registry record does not report the number analyzed for the primary endpoint or explain exclusions. A precise interpretation of the primary question would require those outcome counts, an effect estimate, and an uncertainty measure, together with the analysis definition.
The reasonable statistical reading is therefore limited: a randomized comparison was registered and completed, and the primary endpoint was defined, but the posted information does not provide a usable primary-outcome result. This is a limitation of what can be concluded from the registry record, not evidence that either induction approach produced a particular delivery outcome.
9. Statistical Methods Explained
Statistical methods help translate observed outcomes into an estimate of how groups compare, while making the uncertainty in that estimate visible. For this trial, the central endpoint is categorical: each participant’s delivery mode is described as cesarean section or vaginal delivery. The registry does not report the category counts by randomized group, so a numerical comparison cannot be reconstructed from the posted primary-outcome information.
What does randomization contribute?
In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences between groups at the start of follow-up. Randomization does not ensure exact balance in every characteristic, and it does not eliminate the need to report who was analyzed, how outcomes were measured, and how missing data were handled. The registry identifies this study as randomized but does not report the sequence-generation or allocation-concealment procedures.
How would a categorical endpoint be compared?
For a binary outcome, a common analysis compares the number or proportion of participants with the event in each group. Here, delivery mode includes two categories, and the primary outcome is titled as the rate of cesarean section. A group comparison could be expressed using an absolute difference or a relative measure, with a confidence interval to show the range of effects reasonably compatible with the observed data under the model. These are general statistical concepts; no such estimate or interval for this endpoint is reported in the registry record.
A confidence interval is not a guarantee that the true effect lies within its limits. In general, it describes uncertainty under the statistical method and assumptions used. A narrow interval indicates greater precision than a wide interval, while an interval spanning effects in different directions may leave the direction or size of a contrast uncertain. Because no primary-outcome estimate or interval is reported, the precision of the treatment comparison cannot be assessed.
What does a p-value answer?
In general, a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions were true. It does not measure the probability that the null hypothesis is true, the size of an effect, or its clinical importance. The registry does not report a p-value for the primary endpoint. A p-value alone, even if available, would not replace the group counts and effect estimate needed to understand the result.
Why does the analysis population matter?
In general, an intention-to-treat analysis compares participants according to their randomized groups, while other analysis populations can apply different inclusion rules. The selected population can affect interpretation, particularly if participants do not receive assigned treatment or lack outcome data. The registry record does not report whether the primary analysis used an intention-to-treat population, a per-protocol population, or another definition. It also does not report adherence, crossover, exclusions, or the number analyzed for the primary outcome.
How should missing data be considered?
Missing outcomes can undermine a comparison if the reasons for missingness are related to treatment assignment or the outcome. General approaches include describing the amount and pattern of missingness, stating assumptions, and conducting appropriate analyses to assess sensitivity to those assumptions. The registry record does not report missing primary-outcome data, the reasons for any missingness, or methods used to address it. No assumptions about complete follow-up or imputation should be made from the absence of these details.
What can be inferred from the adverse-event counts?
The adverse-event record gives counts of zero serious events and zero other affected participants in both groups, with zero deaths in both groups. Counts of zero are descriptive observations, not proof that the underlying event risk is zero. General statistical reasoning recognizes that the amount of information in a zero-event observation depends on the number monitored, follow-up, event definitions, and ascertainment. The registry record does not provide enough detail about those features to calculate or interpret a risk bound, and no such calculation is made.
What about sample-size planning and power?
In general, sample-size planning depends on assumptions about the outcome frequency, the effect the study is intended to detect, the desired power, the significance threshold, and allocation. The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It does not report the resulting planning figures in the information available for this analysis, nor does it report the trial’s own sample-size justification. The illustration should not be read as the protocol’s design rationale or as observed power.
Observed power is not a useful substitute for an effect estimate and its confidence interval. In general, after a study is completed, power calculations based on the observed effect largely restate information already reflected in the estimate and its uncertainty. The record does not report an observed-power analysis. No conclusion about whether enrollment was adequate for the primary question can be drawn from enrollment alone.
How should multiple outcomes and analyses be understood?
Testing multiple outcomes or conducting multiple analyses can increase the chance that at least one result appears noteworthy by chance, depending on the testing strategy. General methods to address multiplicity include prespecifying a primary endpoint, defining a testing hierarchy, or adjusting the interpretation of multiple tests. The registry identifies a primary endpoint and a secondary infectious-morbidity outcome, as well as three analyses, but the details of the analysis plan and any multiplicity handling are not reported. It is therefore not possible to determine whether or how multiplicity was addressed.
Overall, the statistical methods needed to assess the primary contrast are not sufficiently documented in the registry record. The record gives design features and endpoint definitions, but not the primary outcome counts or analysis output. Statistical concepts can explain what those results would mean in general; they cannot fill in results that are not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry names cesarean section as the primary outcome and maternal and neonatal infectious morbidity as a secondary outcome. It also lists three analyses. The record does not describe the analyses, the statistical plan, the hierarchy among outcomes, or any adjustment for multiple comparisons. Multiplicity matters in general because examining several outcomes, time points, or analytic approaches can raise the chance of a chance finding if results are interpreted without regard to how many comparisons were made. The available information does not establish whether that issue affected this trial’s analyses.
The primary outcome is described as having several categories or time points and is not reduced to one comparison. The record does not report the category-specific counts or identify a single effect estimate for the primary question. The endpoint timeframe is within 48 hours, but the handling of other time points or categories is not reported in the registry record.
The registry does not report the primary-outcome analysis population, the number of participants included in that analysis, or whether participants were analyzed according to randomized assignment. It does not report missing outcome counts, reasons for missingness, exclusions, imputation, or sensitivity analyses. These omissions limit assessment of possible bias from incomplete follow-up or analysis choices.
These details are not proof that the investigators failed to address multiplicity or missing data. They mean that the registry record does not document how these issues were handled. Without that documentation and the outcome results, the reliability and interpretation of the analyses cannot be independently assessed from the posted 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 |
|---|---|---|---|
| Misoprostol | 0 | 117 | 0.0% |
| Oxytocin Alone | 0 | 113 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Misoprostol | 0 of 117 |
| Oxytocin Alone | 0 of 113 |
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 |
|---|---|
| Misoprostol | 0 of 117 |
| Oxytocin Alone | 0 of 113 |
The registry lists 117 participants at risk in the misoprostol group and 113 at risk in the oxytocin-alone group for the adverse-event record. In both groups, serious events are recorded as zero, other affected participants as zero, and deaths as zero. These figures describe the posted adverse-event entries; they are not the cesarean outcome results.
A zero count means that no event was recorded in the relevant category in this registry entry. It does not establish that no event occurred outside the collection or reporting process, and it does not prove that the underlying risk is zero. General interpretation of adverse-event data depends on definitions, surveillance, follow-up duration, completeness, and how events were classified. Those details are not reported in the registry record.
The record does not list serious-event terms. It also does not explain how “other” events were defined or whether the adverse-event figures cover all participants and the same observation period. The figures therefore support a limited descriptive statement about what was recorded, not a definitive comparison of safety between groups. No risk difference or other comparative measure is reported for these adverse-event counts.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group comparison of misoprostol and oxytocin alone was registered as completed, and it identifies cesarean section within 48 hours as the primary outcome. It also identifies maternal and neonatal infectious morbidity as a secondary outcome. Those descriptions clarify the trial question and design, but they are not themselves evidence of a treatment effect.
The posted information does not report the cesarean and vaginal-delivery counts by group, a primary-outcome effect estimate, a confidence interval, or a p-value. As a result, it does not show whether the groups differed in delivery mode or how precise any difference might be. It also does not provide a numerical result for infectious morbidity. No conclusion that one approach is better, worse, equivalent, or safer can be drawn from these missing outcome results.
The adverse-event entries report zero serious events, zero other affected participants, and zero deaths in each group. These are limited descriptive findings. They do not show that adverse events are impossible, and they cannot replace the primary-outcome analysis. The record does not provide enough event-collection detail to determine the scope or completeness of safety ascertainment.
In general, a trial result should be interpreted using the estimated effect, its uncertainty, outcome definitions, analysis population, and missing-data handling. The registry record does not document enough of those elements to support a complete statistical interpretation. Enrollment of 230 is a design and conduct descriptor, not a measure of treatment benefit or precision by itself.
The most accurate conclusion is therefore about the information available, rather than about clinical effectiveness: the primary question was registered, but its results are not reported in a form that permits a comparison. This does not imply that the trial found no difference; it means the posted record does not state the result needed to determine whether a difference was observed.
13. Why This Trial Matters Statistically
This trial is statistically important as an example of the distinction between a clearly stated clinical question and an interpretable reported result. The registry identifies a randomized comparison, two induction approaches, and a primary outcome centered on delivery mode. Those elements define what investigators intended to compare. A statistical conclusion, however, also requires outcome data and an analysis that connects those data to the comparison.
The primary endpoint is categorical and includes cesarean and vaginal delivery. Such outcomes can be summarized with group counts and compared using an effect estimate with uncertainty. The registry record does not provide a single comparison or the underlying category counts. Readers therefore cannot assess the direction, magnitude, or precision of the primary outcome from the posted information.
The record also illustrates why outcome reporting and analysis transparency matter. It lists a secondary infectious-morbidity outcome and three analyses, but does not describe their findings or methods. Without a clear account of the analysis population, missing data, and handling of multiple outcomes, it is difficult to judge how the planned questions were answered. These gaps do not establish that the study was conducted improperly; they limit what can be evaluated from the registry record.
The adverse-event entries offer a separate, narrow descriptive view: both groups have zero recorded serious events, other affected participants, and deaths. Statistical interpretation must keep that information distinct from the primary endpoint and avoid treating zero recorded events as proof of zero risk. For clinical researchers and biostatisticians, the central lesson is that randomized design is valuable, but transparent outcome reporting is necessary for readers to assess what the trial actually found.
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 for interpretation is that the registry does not report the primary endpoint’s group-specific counts or a single comparison. The primary outcome is described as mode of delivery within 48 hours, but it has multiple categories or time points and is not reduced to one comparison. Without the cesarean and vaginal-delivery results, the primary clinical question cannot be answered from the record.
The record does not report an effect estimate, confidence interval, or p-value for the primary outcome. It also does not provide a numerical result for maternal and neonatal infectious morbidity, which is listed as a secondary outcome. Although three analyses are listed, their methods and results are not reported in the registry record.
Important design and analysis details are also absent. The record does not describe eligibility criteria in detail, participant characteristics, the randomization procedure, allocation concealment, the analysis population, treatment adherence, or exclusions. It does not report missing primary-outcome data, reasons for missingness, or methods used to handle missing outcomes. The trial’s own sample-size justification is not reported. These limitations prevent assessment of baseline comparability, follow-up completeness, and the precision intended by the study design.
The registry describes masking as none, but it does not clarify who knew treatment assignment or whether outcome assessment was independent. It also does not give detailed definitions or ascertainment procedures for adverse events. The zero adverse-event counts should therefore be read as recorded entries, not as evidence that no risk existed.
These are limitations of the registry information available for interpretation. They do not establish that the underlying trial lacked a protocol, collected no outcomes, or omitted analyses; such claims are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cervical Ripening in Premature Rupture of Membranes — NCT02314728.
- Registry record last updated 2021-08-10; status last verified 2021-08.
- Results first posted 2021-08-10.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed, randomized, open-label, parallel-group trial sponsored by Montefiore Medical Center, with an enrollment of 230. The recorded start date is 2014-10-01 and the primary completion date is 2016-05-30. The comparison was vaginal misoprostol, described as 25mcg every 4 hours according to hospital protocol, versus an oxytocin infusion titrated according to hospital protocol or until adequate contractions.
The primary outcome was the rate of cesarean section, defined through mode of delivery within 48 hours. Maternal and neonatal infectious morbidity was listed as a secondary outcome. The registry does not report the primary outcome counts or a single comparison, and it does not report numerical results for the secondary outcome. It lists three analyses without describing their methods or findings.
The adverse-event record reports zero serious events, zero other affected participants, and zero deaths in both groups. The registry does not report enough information to turn these entries into a comprehensive safety comparison. Overall, the design and endpoint are identifiable, but the posted outcome information does not support a statistical conclusion about the primary treatment comparison.