NSAID Use in Postpartum Hypertensive Women: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for NSAID Use in Postpartum Hypertensive Women (NCT02902172), a randomized phase 4 study. The primary outcome is Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2..

2. Clinical Question

The primary measure is a change in mean systolic blood pressure, in mmHg, over a two-day timeframe. Day 1 is defined as the mean of measurements from 0 hours to 23 hours after delivery; day 2 is the mean from 24 hours to 47 hours after delivery. The registry describes the objective as determining whether NSAIDs in the postpartum period raise blood pressure in women with a hypertensive disorder.

The comparison is between assigned groups, not a comparison of each participant’s response to both medicines. The registry describes a randomized, parallel-group trial with triple masking. Its summary says that women would be placed into groups and blood pressures collected during the postpartum period. The record does not report further details about how assignment was generated or how masking was implemented.

The question is specifically about short-term change across the postpartum days defined for the primary endpoint. It is not a measure of blood pressure at all later postpartum visits: later monitoring is mentioned in the NSAID arm description, but the primary endpoint timeframe is two days. The record does not report results for blood pressure at one week or six weeks.

3. Trial Design

The registry describes NCT02902172 as a phase 4 randomized, triple-masked, parallel-group study sponsored by St. Louis University. It began on 2017-03-15, had a primary completion date of 2017-10-08, and is listed as terminated. The reason for termination is not reported in the registry record. Enrollment was 36.

The intended study population was women with hypertension, including hypertension before pregnancy or hypertension induced during pregnancy, who delivered an infant vaginally. The registry summary describes two postpartum groups: one receiving ibuprofen for pain control and the other receiving Tylenol. The intervention records identify the groups as NSAID and acetaminophen. The precise NSAID dose and schedule, and the acetaminophen dose and schedule, are not reported in the registry record.

The primary endpoint compares mean systolic blood pressure from postpartum day 1 with mean systolic blood pressure from postpartum day 2. Day 1 covers 0 hours to 23 hours after delivery, and day 2 covers 24 hours to 47 hours after delivery. The endpoint timeframe is two days. The registry also lists change in mean diastolic blood pressure over the same postpartum days as a secondary outcome.

The posted primary outcome records include 16 participants in the acetaminophen group and 20 in the NSAID group. These outcome counts add up to the registry’s enrollment of 36, but the record does not explain participant flow, exclusions, or whether all enrolled participants contributed to every endpoint. The planned sample-size justification and the original assumptions used to design the trial are not reported in the registry record.

Although the trial is described as triple-masked, the roles masked, masking procedures, and any changes to masking are not reported in the registry record. The allocation method, eligibility criteria beyond the summary description, and details of site conduct are also not reported. The record lists one analysis and a total of two outcome measures; it posts one secondary outcome.

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

Analysis population for the primary outcome, as defined in the registry: Mean difference day 1 compared to day 2 of systolic blood pressure

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 Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2., measured over 2 days.

The primary endpoint is the change in mean systolic blood pressure, measured in mmHg, from postpartum day 1 to postpartum day 2. Day 1 is the mean of systolic blood pressure readings from 0 hours to 23 hours after delivery; day 2 is the mean from 24 hours to 47 hours after delivery. The registry describes the group result as the mean increase and standard deviation for each group.

This endpoint turns repeated blood pressure measurements over the two postpartum intervals into a comparison of change. In general, a change measure can help describe whether the outcome tended to rise or fall between the defined periods, rather than reporting only a single reading. Comparing the group changes addresses the trial’s stated question about whether postpartum NSAID use is associated with a different short-term systolic blood pressure pattern than acetaminophen use. This is a statistical description of the endpoint, not a conclusion about treatment benefit or harm.

The posted group means are increases of 7.5 mmHg for acetaminophen and 5.0 mmHg for NSAID, with standard deviations of 13.8 and 6.1, respectively. The recalculated unadjusted mean difference for NSAID compared with acetaminophen is -2.5 mmHg, with a 95% confidence interval from -9.771 to 4.771. The posted sponsor analysis is a separate non-inferiority analysis, and the registry does not report its confidence interval or non-inferiority margin.

The endpoint is restricted to systolic pressure over the first two postpartum days. It does not by itself describe later blood pressure, the broader course of hypertension, or outcomes beyond the measured endpoint.

7. Results Posted in the Registry

• NSAID: mean 5.00 versus 7.50 on control; difference -2.50 (95% CI -9.77 to 4.77), standardized effect d = -0.24; z-test p = 0.500.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NSAID: mean 2.70 versus 0.40 on control; difference 2.30 (95% CI -3.97 to 8.57), standardized effect d = 0.25; z-test p = 0.472.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between NSAID and the control. The interval gives the range of effects that remain compatible with the data.

The registry posts change in mean diastolic blood pressure from postpartum day 1 to postpartum day 2 as the secondary endpoint. The overall pattern is not a close match to the primary endpoint’s arm-level pattern: the posted diastolic means move in different relative directions across groups than the systolic means. The secondary recalculation is uncertain, with a confidence interval that includes zero. This secondary result does not resolve the uncertainty in the primary comparison and should not be treated as independent confirmation of a treatment effect.

The registry lists two outcome measures in total and one analysis, and it posts one secondary outcome. It does not report a sponsor analysis for the secondary endpoint. The unadjusted recalculation for this outcome is an additional descriptive comparison, not a replacement for a planned analysis or a basis for a definitive claim.

When several outcomes or comparisons are examined, the chance of finding a nominally notable result by chance can increase. General explanation: multiplicity procedures can control that issue by adjusting the testing strategy, but the registry record does not report whether such a procedure was planned or used. As a result, unadjusted secondary findings carry less weight than a prespecified primary analysis, particularly when the statistical plan and multiplicity handling are not available.

The secondary endpoint is measured over the same two postpartum days as the primary endpoint, but it concerns diastolic rather than systolic pressure. It therefore provides related information, not a substitute endpoint. The record does not post other secondary outcome results, and later follow-up blood pressure results are not reported. Conclusions should remain confined to the posted outcomes and their uncertainty.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a mean change in systolic blood pressure measured in mmHg. The registry reports an arm-level mean and standard deviation for each group. A mean describes the center of the observed changes, while a standard deviation describes how much those individual changes vary around the mean. These summaries answer different questions: the mean describes the average direction and size of change, and the standard deviation describes spread among participants.

What does the recalculated mean difference represent?

The recalculated comparison subtracts the acetaminophen group mean from the NSAID group mean, giving a mean difference of -2.5 mmHg. This is a simple, unadjusted comparison based on the posted group summaries. The negative sign indicates that the posted mean increase was lower in the NSAID group than in the acetaminophen group. It does not mean that every participant’s blood pressure changed in that direction, and it does not account for any participant-level covariates.

The recalculated standard error reflects uncertainty in the estimated difference given the group sizes and variability. A confidence interval combines the estimate with that uncertainty to give a range of values compatible with the data under the method’s assumptions. The interval from -9.771 to 4.771 includes zero, so the recalculated summary does not distinguish the observed estimate clearly from no between-group difference. The unadjusted p-value of 0.5 is another summary of compatibility with a null comparison under the calculation’s assumptions; it is not the probability that the null is true.

Why is the sponsor analysis different?

The registry reports a Wilcoxon (Mann-Whitney) analysis labeled non-inferiority, with a net mean difference of 0.85 and p <0.05. A Wilcoxon (Mann-Whitney) procedure is rank-based and evaluates the relative ordering of observations across groups, rather than relying on the same mean-and-standard-deviation calculation used for the simple recalculation. The posted records therefore do not present identical analyses. The sponsor result is the trial’s own reported analysis and takes precedence over the recalculation when describing the trial result.

Non-inferiority is a specific type of comparison. In general, it asks whether an intervention is not worse than a comparator by more than a prespecified margin. The margin and the details of how the sponsor defined and tested non-inferiority are not reported in the registry record. Without those details or the sponsor’s confidence interval, the reported p-value and net difference cannot be fully interpreted as a non-inferiority finding. The discrepancy between the sponsor analysis and the recalculation is flagged in the record; its cause is not reported.

Why can over-dispersion matter?

General explanation: a continuous outcome can show more variability than a statistical model assumes. When variability is larger than assumed, standard errors may be too small and confidence intervals may be too narrow, making an estimate appear more precise than it is. The posted summaries show standard deviations of 13.8 and 6.1 for the primary endpoint, but the registry does not report a model-based dispersion assessment or a variance adjustment. The recalculation uses the posted summaries and should be read as an unadjusted illustration, not as a substitute for the sponsor’s analysis.

What does the secondary comparison add?

The posted secondary measure is mean diastolic blood pressure change from postpartum day 1 to day 2. The arm means are 0.4 mmHg for acetaminophen and 2.7 mmHg for NSAID, with standard deviations of 11.1 and 7.1. The recalculated unadjusted mean difference is 2.3 mmHg, with a 95% confidence interval from -3.966 to 8.566 and p = 0.472. As with the primary recalculation, this comparison is based on posted summary statistics and is not the sponsor’s reported analysis. The registry does not post a sponsor analysis for this secondary endpoint.

Statistical methods are most informative when the endpoint, estimand, analysis population, missing-data handling, and decision criteria are clear. The registry record identifies the outcome summaries and the sponsor’s method, but it does not report the full statistical analysis plan, the analysis population, handling of missing observations, or multiplicity procedure. Those omissions constrain interpretation, especially for the sponsor’s non-inferiority result and for the secondary endpoint.

The trial’s stated design is randomized and parallel-group, with triple masking. Randomization can help balance measured and unmeasured characteristics across groups in expectation, while masking can reduce some forms of bias. General explanation: these design features do not guarantee balance in a small trial, and their value depends on how they were carried out. The allocation sequence and masking details are not reported in the registry record, so their implementation cannot be evaluated from the posted information.

11. Confidence Intervals and Precision

The recalculated primary mean difference is -2.5 mmHg for NSAID compared with acetaminophen. Its 95% confidence interval is -9.771 to 4.771. A confidence interval expresses statistical uncertainty around an estimate: under the method’s assumptions, it indicates a range of values that are reasonably compatible with the observed data. It does not guarantee that the true value lies in the interval, and it does not assign a probability to the treatment effect.

This interval includes zero and contains values on both sides of zero. Thus, the recalculation does not precisely establish whether the average systolic change was lower or higher in the NSAID group than in the acetaminophen group. The breadth of the interval matters as much as the point estimate: the observed estimate is -2.5 mmHg, but the data are compatible with a range of between-group differences. It would be misleading to present the point estimate alone as a definitive result.

The outcome groups contain 16 and 20 participants. The primary endpoint standard deviations are 13.8 and 6.1, indicating differing amounts of observed variation between the groups. In general, a small sample and substantial variability can limit precision. The registry does not report whether the trial’s original design anticipated these group sizes or the observed variability; its original sample-size assumptions are not reported in the registry record.

The sponsor’s own non-inferiority analysis reports a net mean difference of 0.85 and p <0.05 but no confidence interval. A p-value alone does not show the range of effects compatible with the sponsor analysis. The non-inferiority margin is also not reported, so the precision and decision threshold behind that analysis cannot be assessed from the registry record. Because the record flags a discrepancy, the sponsor analysis takes precedence over the simple recalculation, while the recalculation remains a distinct unadjusted summary-based analysis.

Confidence intervals are useful for assessing precision, but they do not resolve design limitations, missing-data concerns, or questions about the analysis plan. Those details are not reported in the registry record.

12. 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 trial’s original design assumptions. For this continuous outcome, each figure is the number of participants per arm, not a total number of events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the number of participants per arm that the planning calculation indicates would be needed to have an 80% chance of detecting the specified effect under those assumptions. The 90% power column gives the corresponding per-arm number for a 90% chance. These are planning concepts conditional on the assumptions; they do not describe the probability that the completed trial detected an effect.

The rows for planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect illustrate how the target effect size changes the required sample. The smaller the effect a study is designed to detect, the more participants it generally needs, because smaller differences are harder to distinguish from random variation. The listed requirements are much larger than the posted outcome group counts of 16 and 20, so the observed estimates should be read with attention to their uncertainty.

These figures are not observed power. Observed power is not a useful substitute for examining the estimate and its confidence interval; the planning figures instead show what sample sizes follow from the stated assumptions and chosen effect sizes. They should not be read as evidence that the original trial was designed around the observed effect.

13. 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, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.500; pooled standard deviation σ = 10.238.
2. n = 2 × (1.96 + 0.842)² × 10.238² / -2.500² = 263.2, rounded up to 264 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
delta <- -2.5                      # observed difference in means
sigma <- 10.2377473395389                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^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 (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2902172)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 264 (80% power), 353 (90% power)
 75% of observed effect: n per arm = 468 (80% power), 627 (90% power)
 50% of observed effect: n per arm = 1,053 (80% power), 1,410 (90% power)
power.t.test: 264.2 
Simulated power at n = 264 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-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.

14. Analyses Reported by the Sponsor

The registry’s sponsor-reported primary analysis uses the Wilcoxon (Mann-Whitney) method and is labeled non-inferiority. It reports a net mean difference of 0.85 and p <0.05, without a posted confidence interval. The registry also flags a discrepancy between this sponsor analysis and the unadjusted recalculation from the group summaries. The sponsor’s own analysis takes precedence when describing the trial’s reported result.

The recalculation estimates a simple unadjusted mean difference of -2.5 mmHg, with a 95% confidence interval from -9.771 to 4.771 and p = 0.5. It is not the same analysis as the sponsor’s rank-based non-inferiority test, and it should not be used to overwrite or reinterpret the sponsor’s stated result. It serves as a separate way to describe the posted arm-level means and variability.

The record does not report the non-inferiority margin, the sponsor analysis confidence interval, the detailed hypothesis-testing procedure, or the analysis population. Those missing details prevent a full appraisal of the non-inferiority claim and a reconciliation of the different reported results. No explanation for the discrepancy is reported in the registry record.

15. Multiplicity, Missing Data and Analysis Populations

The record identifies a primary systolic blood pressure endpoint and a secondary diastolic blood pressure endpoint. It lists two outcome measures overall and one analysis, while one secondary outcome is posted. The registry does not report whether the primary endpoint was the sole confirmatory test, whether a hierarchy among outcomes was planned, or whether statistical significance thresholds were adjusted for multiple testing. A multiplicity plan is not reported in the registry record.

General explanation: testing several outcomes can increase the opportunity for a chance finding if each result is considered separately. Adjustment or a prespecified testing hierarchy can address this concern, but no such procedure can be inferred from the posted results. The sponsor’s primary analysis is labeled non-inferiority, yet the non-inferiority margin and detailed decision rule are not reported. The reported p-value alone is insufficient to reconstruct those elements.

The registry does not report how missing blood pressure observations were handled, whether any participants were excluded from an endpoint analysis, or whether imputation was used. The outcome group counts are 16 for acetaminophen and 20 for NSAID, but the record does not provide a participant flow account explaining whether those counts reflect all enrolled participants, exclusions, or missing endpoint data. It also does not identify an intention-to-treat, per-protocol, or other analysis population.

The registry describes randomization and triple masking but does not report the randomization sequence, allocation concealment, the roles masked, or the procedures used to maintain masking. It does not report protocol deviations or whether the planned analysis changed. These omissions do not establish that the trial had a particular flaw; they mean that those aspects cannot be evaluated from the registry record.

The absence of these details is especially relevant to the sponsor’s non-inferiority result, since interpretation depends on the margin and analysis population as well as the reported test. It also limits assessment of the secondary result and of whether the posted analyses reflect the originally planned approach.

16. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The posted adverse-event figures list zero serious adverse events in the acetaminophen group, with 16 at risk, and zero in the NSAID group, with 20 at risk. The record also lists zero other adverse events in each group and zero deaths in each group. No top serious adverse-event terms are listed.

These figures describe the events recorded in the registry for the groups and at-risk counts shown. They do not establish that no event occurred outside the recorded definitions or reporting period, and they do not show whether an event was judged related to a study intervention. The record does not report additional safety-analysis details, event collection procedures, or the duration of safety follow-up for these figures.

The trial is listed as terminated, but the reason for termination is not reported in the registry record. The absence of posted events should therefore be read as a description of the recorded safety counts, not as proof of an absence of risk. The small group counts also limit what can be inferred about uncommon events.

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

The posted primary outcome describes short-term systolic blood pressure change between postpartum day 1 and postpartum day 2 among women with hypertension who delivered vaginally. The arm means were 7.5 mmHg for acetaminophen and 5.0 mmHg for NSAID. The unadjusted recalculation estimates a mean difference of -2.5 mmHg, with a 95% confidence interval from -9.771 to 4.771. That interval includes zero and is broad enough that the recalculation does not precisely determine the direction or size of the difference.

The sponsor’s own analysis is reported as a Wilcoxon (Mann-Whitney) non-inferiority analysis, with a net mean difference of 0.85 and p <0.05. The registry flags a discrepancy with the recalculation, and the sponsor analysis takes precedence. However, the non-inferiority margin, confidence interval, and detailed decision rule are not reported, so the posted record does not allow a full independent assessment of that result.

The findings do not establish that either pain-control option increases or decreases blood pressure. They do not describe every participant’s response, and they do not establish what happens after the two-day primary endpoint timeframe. Blood pressure monitoring at one week and six weeks is mentioned in an arm description, but results for those later times are not reported in the registry record.

The posted secondary diastolic outcome is related to the primary question but does not remove its uncertainty. The missing statistical-plan details, including missing-data handling, analysis population, multiplicity procedures, and non-inferiority margin, further limit interpretation. The trial’s terminated status is part of the record, but the reason is not reported.

These results are statistical descriptions of the posted record, not medical advice. They should not be generalized beyond the population, endpoint, and follow-up information reported. The registry does not provide enough detail to draw broader conclusions about postpartum blood pressure or outcomes outside the measures listed.

18. Why This Trial Matters Statistically

This trial raises a practical statistical question about comparing changes in a clinical measure over closely defined time intervals. By specifying the postpartum day windows, the registry makes the primary endpoint’s timing explicit: day 1 covers 0 hours to 23 hours after delivery, and day 2 covers 24 hours to 47 hours after delivery. Clear timing matters because a change endpoint is only interpretable in relation to its measurement periods.

The contrast between the sponsor analysis and the recalculation illustrates why an effect estimate should be read together with its method and uncertainty. The recalculation uses arm-level means and standard deviations to produce an unadjusted mean difference and confidence interval. The sponsor reports a Wilcoxon (Mann-Whitney) non-inferiority analysis. These are not interchangeable summaries, and the discrepancy makes transparency about the prespecified estimand, analysis method, non-inferiority margin, and analysis population especially important.

The small posted outcome groups also show why point estimates alone can be misleading. The recalculated primary interval spans values below and above zero, indicating limited precision for the between-group comparison. Planning illustrations based on the observed effect show how required sample sizes depend on the target effect and power assumptions; they are not evidence about the trial’s original design or its observed power.

Finally, the record demonstrates the importance of complete reporting. Information on missing data, multiplicity, participant flow, and the reason for termination is not reported. Without such details, readers can describe the posted findings but cannot fully assess the analysis choices or the path from randomization to the reported results. This is a reason to distinguish clearly between what the registry reports, what a summary-based recalculation estimates, and what remains uncertain.

19. 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 outcome groups are small, with 16 participants in the acetaminophen group and 20 in the NSAID group. The primary recalculated confidence interval is broad and includes zero, limiting the precision of the estimated mean difference. The group standard deviations also differ, and the registry does not provide participant-level data or a detailed model specification for evaluating the distribution of changes.

The sponsor’s analysis and the recalculation are discrepant. The sponsor analysis is labeled non-inferiority and reports a net mean difference of 0.85 with p <0.05, while the unadjusted recalculation from the posted summaries estimates -2.5 mmHg with p = 0.5. The sponsor analysis takes precedence, but its confidence interval, non-inferiority margin, detailed decision rule, and analysis population are not reported. The record does not explain the discrepancy.

The registry does not report the original sample-size justification, the planned effect size, or the assumptions used for trial design. The planning illustrations are based on the observed effect and should not be confused with the original design rationale. The record also does not report missing-data handling, participant flow, protocol deviations, or whether the posted group counts include all randomized participants in the endpoint analyses.

The population described is limited to women with hypertension before or during pregnancy who delivered vaginally. Details of eligibility criteria, intervention dose and schedule, allocation generation, and implementation of triple masking are not reported in the registry record. Although later blood pressure monitoring is mentioned in an arm description, results at one week and six weeks are not posted. The reason for the terminated status is not reported.

These gaps constrain appraisal and generalizability. They do not establish that a particular method was inappropriate or that any unreported event occurred; they identify information that is unavailable in the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: NSAID Use in Postpartum Hypertensive Women — NCT02902172.
• Registry record last updated 2018-10-31; status last verified 2018-10.
• Results first posted 2018-10-31.
• 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.

23. Record Summary

NCT02902172 is a phase 4 randomized, triple-masked, parallel-group trial sponsored by St. Louis University and listed as terminated. It enrolled 36 women described as having hypertension before or during pregnancy and delivering an infant vaginally. The comparison was NSAID, identified in the registry summary as ibuprofen, versus acetaminophen.

The primary endpoint was change in mean systolic blood pressure from postpartum day 1 to day 2, measured in mmHg. The posted group means were 7.5 for acetaminophen and 5.0 for NSAID. The sponsor reported a Wilcoxon (Mann-Whitney) non-inferiority analysis with net mean difference 0.85 and p <0.05. A separate unadjusted recalculation estimated a mean difference of -2.5, with a 95% confidence interval from -9.771 to 4.771; the registry flags a discrepancy, and the sponsor’s analysis takes precedence.

The record posts one secondary outcome, change in mean diastolic blood pressure. Details needed to fully assess the non-inferiority analysis, missing data, multiplicity, participant flow, and the reason for termination are not reported in the registry record.