Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy (NCT00671060), a randomized phase 3 study. The primary outcome is Successful Expulsion of Fetus and Placenta Within 48 Hours.

2. Clinical Question

The clinical question is a comparison between two doses of the same medication, not a comparison with no treatment, surgery, or another medication. Both groups were assigned misoprostol, and the primary endpoint focused on whether expulsion of both the fetus and placenta was successful within the stated timeframe. The study description situates the question in fetal death at 14–28 weeks of pregnancy when complete expulsion had not occurred. The registry background discusses the need for uterine evacuation and uncertainty about dose and administration, but those statements describe the rationale rather than additional outcomes measured in this comparison.

The record identifies the study as a phase 3 randomized trial and lists a total enrollment of 153. The outcome counts are recorded for 76 participants in each dose group. Because one participant assigned to the higher dose was determined ineligible after enrollment and excluded from analysis, and one participant assigned to the lower dose was counted as a failed induction after withdrawal, the analysis-population details matter when interpreting those counts.

3. Trial Design

The registry describes a completed phase 3, randomized, triple-masked, parallel-group trial sponsored by Gynuity Health Projects. Enrollment was 153. The study began in 2008-10, and primary completion was recorded as 2011-12. The intervention groups received different doses of misoprostol; the registry lists both interventions as drugs.

The trial compared 200μg with 100mcg of buccal misoprostol. The descriptions say that participants held tablets in their cheeks for 200 minutes and swallowed any medication remaining afterward. The 100mcg description includes a placebo tablet made to resemble a misoprostol tablet. The arm descriptions are cut off during instructions about what happened if cervical dilation was not complete after six hours. The subsequent dosing or management procedure is therefore not reported in the registry record. The record also does not identify which people or roles were masked, so the meaning of “triple” masking beyond the registry label is not reported in the registry record.

The listed outcome was successful expulsion of the fetus and placenta within 48 hours, recorded as a participant count. The registry reports 60 participants with the outcome among 76 in the 200 Mcg group, and 47 among 76 in the 100 Mcg group. It notes that one person assigned to the 200μg arm was found ineligible after enrollment because gestational age was less than 14 weeks and was excluded from analysis. It also notes that one person assigned to the 100mcg arm was withdrawn because of preeclampsia and included as a failed induction.

The trial’s original sample-size justification, allocation procedure, detailed masking procedures, protocol statistical plan, and interim-analysis plans are not reported in the registry record. Randomization and parallel allocation are listed, but further implementation details should not be inferred from those labels.

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: No participants were excluded from the trial before assignment to groups.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: One woman assigned to the 200μg arm was determined to be ineligible after enrollment due to a gestational age less than 14 weeks. She was not included in the analysis. One woman in the 100mcg arm was withdrawn from the study due to preeclampsia. She was included in the analysis as a failed induction.

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.

6. Primary Endpoint

The registry lists the primary outcome as Successful Expulsion of Fetus and Placenta Within 48 Hours, measured over 48 hours.

The primary endpoint was successful expulsion of both the fetus and placenta within 48 hours. It is a binary outcome at the participant level: each participant either met the stated success definition within the timeframe or did not. The registry presents the result as counts of participants, rather than as a time-to-event measure or a continuous measurement.

This endpoint directly addresses the trial’s stated comparison of two misoprostol doses for uterine evacuation after fetal death. Requiring expulsion of both the fetus and placenta makes the endpoint more specific than measuring only one component. The 48-hour limit also gives the outcome a defined assessment window. A participant who did not meet the full success definition within that window would not be counted as having the primary outcome, consistent with the registry’s description of the participant withdrawn for preeclampsia as a failed induction.

Binary endpoints are useful when the clinical question is whether a clearly defined event occurred by a specified time. They can be summarized as event counts in each group and compared through measures such as a risk difference or risk ratio. Those summaries describe how often the recorded endpoint occurred in the analyzed groups; they do not, on their own, explain why an outcome occurred or establish the broader clinical consequences of the event.

The record does not provide further detail on how successful expulsion was assessed, who adjudicated the outcome, or how cases with incomplete or uncertain assessment were handled. Those endpoint procedures are not reported in the registry record.

7. Results Posted in the Registry

• 100 Mcg: 61.8% (47/76) versus 78.9% (60/76) on control; risk difference -17.1 percentage points (95% CI -31.4 to -2.8), risk ratio 0.78 (0.63–0.97); unadjusted two-proportion z-test p = 0.021.

8. Statistical Interpretation

9. Statistical Methods Explained

For a binary endpoint, the basic result is the number of participants who experienced the event in each group, considered against the number analyzed in that group. Here, the event is successful expulsion of both the fetus and placenta within 48 hours. The registry lists the event counts and analysis denominators for each dose group. This is the foundation for comparisons, but the counts alone do not describe the uncertainty around the difference between groups.

What does a risk difference describe?

A risk difference compares the event proportion in one group with the event proportion in another by subtraction. It is expressed on the absolute scale: it describes how far apart the observed event proportions are. In the posted recalculation, the comparison is oriented as 100 Mcg relative to 200 Mcg, and the estimated risk difference is negative. That direction corresponds to fewer recorded successes in the 100 Mcg group. No further calculation is needed to understand the direction because the registry’s counts show the same ordering.

A confidence interval around a risk difference gives a range of values compatible with the data and the method used, under the assumptions of that method. If an interval excludes zero, the data are inconsistent with no difference at the corresponding confidence level under that analysis. The recalculated interval for this comparison is entirely below zero. This is an unadjusted recalculation from the posted summary statistics, not a substitute for a prespecified sponsor analysis.

What does a risk ratio describe?

A risk ratio compares event proportions by division rather than subtraction. It describes the relative event frequency between groups, while a risk difference describes the absolute separation. The registry reports a sponsor risk ratio of 0.682 and p <0.05 from a chi-squared analysis. The registry does not give a confidence interval for that sponsor estimate. The recalculated risk ratio from the posted counts differs from the sponsor’s reported result; the discrepancy is not explained in the registry record, so the sponsor’s analysis takes precedence as the trial’s own reported analysis.

Odds ratios are another measure for binary outcomes. An odds ratio compares the odds of the event between groups, where odds are the event count relative to the count without the event. Odds ratios and risk ratios are not the same quantity, particularly when events are common. The registry includes a recalculated odds ratio, but the sponsor’s reported analysis is described as a risk ratio. Interpret each measure according to its definition rather than treating all relative measures as identical.

What does a chi-squared test assess?

In general, a chi-squared test compares observed counts across groups with the counts expected under a null hypothesis of no association between group and outcome. For a two-group binary outcome, it assesses whether the observed distribution of successes and non-successes is compatible with equal event proportions under the test’s assumptions. It does not give the size of the difference by itself; that information comes from an effect estimate. The registry names a chi-squared method for the sponsor analysis but does not report additional test details.

A p-value is calculated under a null model and describes how unusual data at least as inconsistent with that model would be, if the model and assumptions were correct. It is not the probability that the null hypothesis is true, and it is not a measure of clinical importance. The recalculated unadjusted p-value is 0.021; the sponsor’s report gives p <0.05. These values belong to different reported analyses, and the discrepancy means the sponsor’s result should be treated as the reported trial analysis rather than replaced by the recalculation.

Why do analysis populations matter?

The registry says that one participant assigned to 200μg was judged ineligible after enrollment because gestational age was less than 14 weeks and was excluded from analysis. It also says that one participant assigned to 100mcg was withdrawn due to preeclampsia and was counted as a failed induction. This is relevant to interpreting the outcome counts because it describes different handling of these two participants. Whether the analysis followed an intention-to-treat principle, a modified intention-to-treat principle, or another prespecified population is not reported in the registry record. The record also does not describe any additional missing data or sensitivity analyses.

Randomization is intended to create groups that are comparable on average with respect to measured and unmeasured baseline characteristics. It does not guarantee that every realized group is identical, and interpretation also depends on whether participants were analyzed according to a prespecified approach. The registry identifies randomization but does not report the sequence-generation or allocation-concealment procedures. These details should not be assumed.

Why does the discrepancy affect interpretation?

The recalculated statistics are simple, unadjusted comparisons based on the posted group counts. A sponsor analysis could differ because of its analysis population, method, coding, or other details, but the reason cannot be identified from this record. Those possibilities are general explanations, not claims about what happened in this trial. The record does not report enough detail to reconcile the two results. Since the discrepancy is flagged, the sponsor’s analysis takes precedence when describing the trial’s own finding; the recalculation remains a transparent descriptive check of the posted counts.

General statistical methods also rely on assumptions. For example, a chi-squared approach uses count-based approximations whose suitability depends on the data structure and expected cell counts. Over-dispersion is a concern in some count models when outcome variability exceeds model expectations; it is not a separate finding reported for this binary endpoint. No assessment of model assumptions, adjusted analysis, subgroup analysis, or sensitivity analysis is reported in the registry record.

10. Confidence Intervals and Precision

Precision concerns how much uncertainty surrounds an effect estimate. The posted counts are point observations in the analyzed groups, while an interval expresses a range of effect values compatible with those observations under the analysis method. A narrow interval indicates greater precision than a wide interval, but precision is not the same as freedom from bias or certainty that an estimate is the true effect.

The unadjusted recalculation reports a risk difference whose interval lies entirely below zero. In the direction used for the recalculation, that interval is consistent with fewer successes in the 100 Mcg group than in the 200 Mcg group. The recalculated risk-ratio interval is also entirely below one. These are recalculated intervals, not the sponsor’s reported interval estimates. The registry gives no confidence interval for the sponsor’s reported risk ratio of 0.682.

Intervals should be interpreted with their method and confidence level in mind. A confidence interval is not a range that has a fixed probability of containing the true effect after the data have been observed. Rather, in general, it is produced by a procedure that would contain the true value at its stated rate over repeated studies if the assumptions and model were appropriate. The registry labels the sponsor’s analysis as 95, but it does not provide interval bounds for that analysis.

The event counts indicate the observed direction of the group difference, but the interval is important because the estimate is based on a finite number of participants. The uncertainty should not be reduced to a binary declaration based on whether a p-value crosses a threshold. The sponsor’s analysis and the unadjusted recalculation also should not be combined as though they were one estimate: they differ, and the record does not explain why. As the discrepancy is flagged, the sponsor’s own analysis takes precedence for the trial’s reported result.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the original trial’s documented design calculation. They give participants per arm for the binary endpoint, not total events. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each scenario uses the stated fraction of the observed effect as the effect to detect.

The first planning row uses 100% of the observed effect and lists 111 participants per arm for 80% power and 148 participants per arm for 90% power. Planning for 75% of the observed effect lists 189 participants per arm for 80% power and 253 participants per arm for 90% power. Planning for 50% of the observed effect lists 405 participants per arm for 80% power and 542 participants per arm for 90% power.

In plain language, the 80% power column gives the planned number per group for a design with an 80% chance of detecting the specified effect under the stated assumptions, if that effect is real and the model assumptions hold. The 90% column uses a higher target chance of detection, so its required group size is larger for each listed effect scenario. Smaller effects are harder to distinguish from random variation, so the planning illustrations require more participants per arm when the assumed effect is smaller.

These figures are not observed power. They are not evidence that the completed trial had a particular chance of detecting its result, and they are not the trial’s original enrollment target justification. The original sample-size assumptions and justification are not reported in the registry record. The curve should be interpreted using the same planning assumptions and in relation to the effect-size scenarios, rather than as a prediction of the trial’s actual outcome.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.789; treatment proportion p₁ = 0.618; average p̄ = 0.704.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6456 = 1.2654.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6342 = 0.5337.
4. n = (1.2654 + 0.5337)² / (-0.1711)² = 110.6, rounded up to 111 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.789473684210526                          # control proportion
p1 <- 0.618421052631579                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(671060)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 111 (80% power), 148 (90% power)
 75% of observed effect: n per arm = 189 (80% power), 253 (90% power)
 50% of observed effect: n per arm = 405 (80% power), 542 (90% power)
power.prop.test: 110.6 
Simulated power at n = 111 per arm: 0.807 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Analyses Reported by the Sponsor

The registry reports the sponsor’s analysis as a chi-squared comparison with a risk ratio of 0.682 and p <0.05. It does not provide a confidence interval for that risk ratio. Separately, an unadjusted recalculation from the posted counts gives a risk difference and a p-value of 0.021. The recalculated effect measures are based on the posted summary counts and are not a replacement for the trial’s own analysis.

The registry flags a discrepancy between the sponsor result and the recalculation. The record does not explain its cause, so no specific explanation should be assumed. Potential sources of differences between analyses can include analysis population or method, but these are general possibilities rather than known features of this trial. The available record does not establish which, if any, accounts for the difference.

Because the sponsor’s analysis is the trial’s reported analysis, it takes precedence over the recalculation when stating the sponsor’s result. The counts and recalculation can still help readers understand the direction and simple unadjusted comparison. The two results should remain clearly distinguished: the sponsor reports a risk ratio, while the recalculation describes an unadjusted comparison from the posted summary statistics.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure and no posted secondary outcomes. It does not report whether additional outcomes were prespecified in the protocol, whether outcomes were changed, or whether any were collected but not posted. The absence of posted secondary outcomes therefore does not establish that no other outcomes were considered or measured.

Multiplicity arises when multiple statistical tests or outcome comparisons are performed. The more tests conducted, the greater the chance that at least one result may appear statistically notable by chance, unless the analysis plan accounts for the multiple comparisons. Whether the trial had multiple planned analyses, comparisons, or time points is not reported in the registry record. No multiplicity adjustment or strategy is described. The registry’s single listed primary outcome does not by itself resolve whether additional testing occurred.

The record notes one participant assigned to the 200μg group was found ineligible after enrollment because gestational age was less than 14 weeks and was excluded from the primary analysis. It also notes one participant assigned to the 100mcg group was withdrawn due to preeclampsia and included as a failed induction. These notes provide limited information about participant handling but do not specify a complete analysis-population definition.

It is not reported whether all randomized participants were otherwise included, how any missing primary-outcome assessments were handled, or whether imputation or sensitivity analyses were used. The registry does not describe an intention-to-treat analysis or another named analysis population. The original protocol analysis plan, interim analyses, and stopping rules are also not reported in the registry record. Consequently, the posted counts should be interpreted with the stated exclusions and inclusion in mind, without assuming a particular missing-data or analysis strategy.

General caution is appropriate when interpreting a reported p-value if the complete set of prespecified and performed analyses is unavailable. This is not a claim that selective reporting or unplanned testing occurred in this trial; the registry record does not provide enough information to determine that.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event record lists serious adverse events affecting 0 participants in each group. The serious-event at-risk counts are 77 for 200 Mcg and 76 for 100 Mcg. The record lists one other adverse event among 77 at risk in the 200 Mcg group and none among 76 at risk in the 100 Mcg group. These are the registry’s posted counts; they do not constitute a full comparison of safety.

The registry does not list serious-event terms, and the top serious-event terms field is empty. It does not describe the type of the one other event in the 200 Mcg group. Death counts are not reported in the registry record. Definitions, severity grading, attribution to treatment, duration of safety follow-up, and methods for collecting adverse events are not reported in the registry record.

At-risk denominators for adverse events need not be interpreted as identical to the primary-outcome analysis counts. The record lists different at-risk counts for the higher-dose adverse-event group and primary outcome group. It does not explain this difference. Small or absent counts in a registry entry should not be read as proof that no other events occurred beyond those captured and posted.

16. What the Result Does, and Does Not, Mean

The posted primary-outcome counts show more recorded successes within 48 hours in the 200 Mcg group than in the 100 Mcg group. The recalculated unadjusted comparison is consistent with that direction, and its interval excludes no difference. The sponsor also reports a chi-squared analysis with a risk ratio of 0.682 and p <0.05. Because the registry flags a discrepancy, the sponsor’s own analysis takes precedence as the reported trial analysis, while the unadjusted recalculation remains a separate descriptive check.

This result concerns only the registry’s defined endpoint: successful expulsion of both fetus and placenta within 48 hours. It does not provide a result for other clinical outcomes, longer-term outcomes, or any outcomes that are not posted. The registry lists no secondary outcomes. It also does not establish why any participant did or did not meet the endpoint.

The result should not be interpreted as a complete comparison of benefits and harms. Safety information is limited to the posted adverse-event counts, with no serious events listed in either group and one other event listed in the 200 Mcg group. Event details and safety follow-up methods are not reported in the registry record. The absence of detail limits what can be concluded from these entries.

Nor does a statistically notable result alone determine the importance of the difference for clinical decisions. Statistical evidence describes the relationship between observed data and an analysis model; the clinical meaning also depends on the outcome definition, uncertainty, trial conduct, and broader evidence. This record does not supply all those elements. The comparison is between two misoprostol doses, not between misoprostol and another treatment or no treatment.

The registry describes randomization, masking, and parallel groups, but does not give enough information to assess important implementation details or fully reconstruct the analysis. Ineligible-participant handling and the withdrawn participant’s outcome classification are explicitly noted. Other missing-data procedures, the trial’s original statistical plan, and the reason for the discrepancy are not reported in the registry record. Those limits warrant keeping the interpretation close to the posted comparison and avoiding claims beyond it.

17. Why This Trial Matters Statistically

This trial is statistically notable as a randomized comparison of two doses of the same drug using a defined binary endpoint and assessment window. That structure makes the main comparison relatively direct: the question is whether the recorded frequency of successful expulsion within 48 hours differed between the assigned dose groups. The registry provides participant counts for both arms and reports a sponsor analysis, allowing readers to distinguish the observed counts from the trial’s stated statistical result.

The record also illustrates why an effect estimate, uncertainty, and analysis method should be read together. Counts indicate the direction of the observed difference. A risk difference expresses that contrast in absolute terms, while a risk ratio expresses it relatively. A p-value addresses compatibility with a null model, but does not communicate the effect’s size or establish its clinical importance. Confidence intervals add information about precision. None of these summaries should be interpreted in isolation.

A further statistical issue is the discrepancy between the sponsor’s reported result and the unadjusted recalculation from the posted counts. The recalculation is useful as a check on the summary statistics, but it cannot replace the trial’s own analysis when the record flags a discrepancy. The reason for the difference is not reported, which highlights the value of accessible analysis-population definitions and statistical methods.

The record’s limited reporting also matters. It identifies randomized, triple-masked, parallel allocation, but leaves allocation procedures, the original sample-size justification, missing-data handling, multiplicity, and interim analyses undocumented. These omissions constrain how fully the analysis can be evaluated. The planning illustrations can help readers understand how assumed effect size relates to required group size, but they do not describe the trial’s original design calculation or observed power.

18. 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 arise from the information available in the registry record. The intervention descriptions are truncated during the instructions for participants whose cervical dilation was not complete after six hours. Further dosing and management details are therefore not reported in the registry record. The record also does not describe how randomization was generated or concealed, which people were masked, or how masking was maintained.

The analysis details are incomplete. The sponsor’s reported risk ratio differs from the simple recalculation using posted summary counts, and the registry does not explain the discrepancy. The sponsor’s own analysis takes precedence, but the absence of additional methods and a sponsor confidence interval limits independent assessment of that result. The original protocol analysis plan, sample-size justification, interim-analysis plan, and stopping rules are not reported in the registry record.

The population notes identify one ineligible participant excluded from the 200μg analysis and one participant withdrawn from the 100mcg group but included as a failed induction. The registry does not state the complete analysis-population definition or describe how other missing outcome data, if any, were handled. It does not report sensitivity analyses to assess the effects of those choices.

Only one outcome measure is posted, with no secondary outcomes listed. Outcome-assessment procedures, adjudication, and details of whether the endpoint was assessed consistently across groups are not reported in the registry record. Adverse-event information is sparse: serious-event terms and the type of the one other event are absent, and death counts are not reported in the registry record. The scope and duration of safety monitoring are also not described.

These limitations do not erase the recorded group counts, but they narrow the conclusions that can be drawn from them. The results apply to the posted endpoint and comparison and should not be extended to unreported outcomes or to other treatment comparisons.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy — NCT00671060.
• Registry record last updated 2013-05-08; status last verified 2013-05.
• Results first posted 2013-05-06.
• 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.

22. Record Summary

NCT00671060 is a completed phase 3 randomized, triple-masked, parallel-group trial sponsored by Gynuity Health Projects. It enrolled 153 participants and compared 200μg with 100mcg buccal misoprostol for fetal death at 14–28 weeks of pregnancy when complete expulsion had not occurred. The trial began in 2008-10, with primary completion recorded as 2011-12.

The primary endpoint was successful expulsion of the fetus and placenta within 48 hours. The registry lists 60 of 76 participants with success in the 200 Mcg group and 47 of 76 in the 100 Mcg group. The sponsor reports a chi-squared analysis with risk ratio 0.682 and p <0.05. A simple unadjusted recalculation differs; because the discrepancy is flagged, the sponsor’s analysis takes precedence.

The record includes limited adverse-event counts and does not post secondary outcomes. Important protocol, analysis, missing-data, and safety details are not reported in the registry record.