ToRsemide for pOstpartum HYpertension: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ToRsemide for pOstpartum HYpertension (NCT02813551), a randomized phase 2 study. The primary outcome is Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg.

2. Clinical Question

The primary endpoint counted participants with sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first. The registry’s stated purpose was to assess whether torsemide reduced the incidence of persistent postpartum hypertension. The results describe the observed group counts and their statistical uncertainty; they do not by themselves establish whether any difference is important to patients or whether it would apply beyond the trial population.

3. Trial Design

The registry describes a randomized, quadruple-masked, parallel-group phase 2 trial. It lists an enrollment of 118 and identifies preeclampsia as the condition. The two groups were torsemide and placebo, each described as a daily 20 mg dose for 5 days. The primary outcome population is labeled intention-to-treat. Group results for that outcome are reported for 59 participants in each arm.

The study is listed as completed. The start is recorded as 2016-08, and primary completion is recorded as 2017-07-28. The sponsor is The University of Texas Health Science Center, Houston. These registry entries describe the recorded design and status; they do not establish whether every planned analysis or follow-up activity was completed as intended.

Randomization is intended to support a fair comparison by reducing systematic differences in treatment assignment. Masking is intended to limit the influence of knowledge about assignment on care, outcome assessment, or reporting. The registry calls the masking quadruple but does not identify the four roles that were masked. Allocation concealment procedures, the randomization method, treatment adherence, and the handling of protocol deviations are not reported in the registry record. The trial’s own sample-size assumptions and design rationale are also not reported in the registry record.

The posted primary results count participants crossing a defined blood-pressure threshold within a short postpartum window. Secondary outcomes cover additional clinical events and measurements, including severe postpartum hypertension, readmission, length of stay, weight change, edema, persistent hypertension at a different threshold, and hypokalemia. Those outcomes do not replace the primary comparison and may have different measurement times or statistical properties.

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: Intention-to-treat

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 Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg, measured over 0-5 days after delivery.

The primary endpoint is the number of participants with persistent postpartum hypertension, defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first. The stated timeframe is 0-5 days after delivery, and the analysis population is intention-to-treat. The registry reports 26 of 59 participants in the torsemide group and 34 of 59 in the placebo group meeting the endpoint.

A binary endpoint records whether each participant did or did not meet a defined criterion. Counting participants makes the outcome interpretable as an event occurrence rather than as a difference in average blood pressure. A threshold can also make a clinical state operational and comparable across trial groups. However, a threshold-based endpoint does not describe the full distribution of blood-pressure measurements or how close participants were to the cutoff. It also depends on the definition and timing used to assess the outcome.

The outcome is relevant to the stated trial question because it measures persistent postpartum hypertension during the early period after delivery. Its short assessment window means it does not, by itself, describe longer-term blood pressure or later postpartum events. The registry separately lists persistent hypertension at a lower threshold as a secondary outcome, which is a different endpoint and should not be conflated with the primary definition.

7. Results Posted in the Registry

• Torsemide: 44.1% (26/59) versus 57.6% (34/59) on control; risk difference -13.6 percentage points (95% CI -31.4 to 4.3), risk ratio 0.76 (0.53–1.10); unadjusted two-proportion z-test p = 0.141.

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.

Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Torsemide: 11.9% (7/59) versus 10.2% (6/59) on control; risk difference 1.7 percentage points (95% CI -9.6 to 13.0), risk ratio 1.17 (0.42–3.26); unadjusted two-proportion z-test p = 0.769.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Torsemide and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants Requiring Postpartum Readmission

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Torsemide: 5.1% (3/59) versus 1.7% (1/59) on control; risk difference 3.4 percentage points (95% CI -3.1 to 9.9), risk ratio 3.00 (0.32–28.02); unadjusted two-proportion z-test p = 0.309.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Torsemide and the control. The interval gives the range of effects that remain compatible with the data.

Weight Change

• 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:
  • Torsemide: mean 3.01 versus 2.08 on control; difference 0.93 (95% CI -0.27 to 2.13), standardized effect d = 0.28; z-test p = 0.128.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Torsemide and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the assessment beyond the primary early postpartum hypertension definition. They include severe postpartum hypertension requiring acute antihypertensives, postpartum readmission, length of hospital stay, weight change, lower-extremity edema, persistent hypertension at a different threshold, and hypokalemia. The registry lists 10 secondary outcomes, while the posted numerical results include a subset. The range of outcomes means that each answers a distinct question, and their timeframes and measurement types are not interchangeable.

Across the posted secondary results, the comparisons do not form a single uniform pattern. Some outcomes are binary event counts and another is a continuous weight measure. The secondary estimates are therefore best interpreted in their own units and with their own uncertainty, rather than combined into a broad claim about benefit or harm. They do not overturn or replace the primary result, which concerns persistent hypertension under its stated threshold and timeframe.

General explanation: when investigators examine multiple outcomes, the chance of seeing at least one apparently unusual result by chance can increase. This is one reason unadjusted secondary analyses generally carry less confirmatory weight than a prespecified primary analysis. The registry does not report a multiplicity adjustment or a hierarchy for interpreting secondary endpoints. The secondary findings should therefore be treated as exploratory or supportive evidence, not as independent proof of an overall treatment effect.

Some outcomes listed in the registry have no numerical results included in the record summarized by the posted results. Their absence from the numeric results does not establish that no events occurred or that no assessment took place. The results and analysis status for those outcomes are not reported in the registry record.

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

• Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)
• Number of Participants Requiring Postpartum Readmission
• Length of Hospital Stay After Delivery
• Weight Change
• Change in Lower Extremity Edema
• Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
• Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
• Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)

9. Statistical Interpretation

10. Statistical Methods Explained

What does the risk ratio describe?

General explanation: a risk ratio compares the probability of an event in one group with the probability in another. A value of 1 corresponds to equal event risks. A value below 1 means the observed event risk is lower in the numerator group, while a value above 1 means it is higher. The registry reports the primary comparison as a risk ratio of 0.76 for torsemide relative to placebo. The accompanying 95% confidence interval is 0.53 to 1.10, so it includes 1. The point estimate and the interval answer different questions: the point estimate gives the central estimate, while the interval conveys uncertainty around it.

What does the risk difference describe?

General explanation: a risk difference subtracts one group’s event probability from the other’s. A value of zero corresponds to equal risks. The recalculated comparison uses torsemide minus placebo, so a negative direction means a lower observed event proportion in the torsemide group. This is an unadjusted calculation from the posted group counts, rather than an adjusted model. Its confidence interval includes zero, indicating that the calculation does not rule out no difference. The risk difference and risk ratio use different scales, but both describe the same binary primary outcome.

How should the p-value be read?

General explanation: a p-value describes how unusual data at least as incompatible with a specified null model would be if that model and the analysis assumptions were correct. It is not the probability that the null hypothesis is true, nor the probability that the result happened by chance. The recalculated unadjusted p-value is 0.141. It does not meet the conventional 0.05 threshold used in the planning assumptions, but that fact alone does not establish the absence of an effect or show that the groups are equivalent. The registry’s own reported analysis does not include a p-value.

Why distinguish the registry analysis from the recalculation?

The posted sponsor analysis reports a risk ratio and its 95% confidence interval. The recalculated figures are simple, unadjusted comparisons derived from the displayed summary counts. They are useful for describing the data on a familiar scale, but they do not reproduce an undocumented analysis method or any adjustment that may have been used by the investigators. The registry record does not report the method behind the sponsor’s risk-ratio analysis. Because the discrepancy indicator is false, there is no stated conflict between the reported sponsor estimate and the recalculated summary; the sponsor’s analysis remains the primary reported analysis.

What is different about continuous outcomes?

General explanation: a continuous outcome, such as weight change, is summarized by a mean and a measure of variability. The secondary weight-change results report means and standard deviations. The standard deviation describes spread among observations; it is not the uncertainty in the mean. A comparison of means can be affected by the distribution of the measurements and by the analysis method. The registry does not report a sponsor analysis for this weight outcome. The posted group summaries allow a basic description, but they do not reveal whether the original analysis used adjustment or how missing measurements were handled.

Why can over-dispersion matter?

General explanation: for count outcomes, over-dispersion means the observed variability is greater than a statistical model expects. If a model assumes less variation than the data have, uncertainty can be understated. The primary endpoint is recorded as a count of participants with a binary event, not as a repeated count process. The registry does not report an over-dispersion assessment or a model that would allow one to evaluate that issue. It should not be assumed that a particular model or variance correction was used.

Overall, these methods describe distinct ways of expressing an outcome and its uncertainty. They do not add information about the trial’s unreported analysis procedures. The primary interpretation should remain anchored to the posted event counts and the sponsor’s reported risk ratio, with recalculated estimates understood as unadjusted summaries.

11. Confidence Intervals and Precision

The sponsor’s primary estimate is a risk ratio of 0.76, with a 95% confidence interval from 0.53 to 1.10. The interval spans values below and above 1, so it includes both a lower relative event risk with torsemide and the possibility of no relative difference. It also leaves room for an estimate in the opposite direction. The point estimate alone therefore gives an incomplete account of what the data can support.

General explanation: a confidence interval is a range produced by a statistical procedure that, under its assumptions, is designed to cover the underlying parameter at the stated rate over repeated applications. It is not a probability statement that the particular fixed effect lies in this specific interval. A wider interval indicates less precision than a narrower interval, all else equal. An interval that includes the null value does not prove no effect; it indicates that the data and method do not exclude that value at the corresponding confidence level.

The recalculated risk-difference interval also includes zero. This agrees with the qualitative message of the sponsor’s interval: uncertainty includes no difference. The unadjusted p-value of 0.141 likewise does not meet the 0.05 level used in the stated planning assumptions. These are related summaries of the data, not independent confirmations.

Precision is limited by the amount of information available for this endpoint and by the number of observed events. The registry reports 59 participants per arm and the event counts, but does not report a prespecified clinically important difference or the original precision target. Statistical compatibility with a null value should not be mistaken for proof of equivalence, and the observed point estimate should not be treated as exact. The most informative reading combines direction, magnitude, interval width, endpoint definition, and study context.

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 planning figures are illustrations based on the observed effect, not the trial’s original design assumptions. For these binary and continuous outcomes, the figures are participants per arm, not a total across arms and not a count of events. The listed planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect to detect is the stated fraction of the observed effect. The trial’s original sample-size justification is not reported in the registry record.

The 80% power column gives the estimated participants per arm for a hypothetical study to have an 80% chance of detecting the specified effect under the planning assumptions, if that effect and those assumptions were correct. The 90% power column gives the corresponding planning count for a 90% chance. These are design probabilities for a future study under a model; they do not describe the probability that the completed trial detected an effect, and they are not observed power.

For the primary outcome, planning for 100% of the observed effect gives 213 participants per arm for 80% power and 284 participants per arm for 90% power. Planning for 75% of the observed effect gives 378 participants per arm for 80% power and 505 participants per arm for 90% power. Planning for 50% of the observed effect gives 847 participants per arm for 80% power and 1,133 participants per arm for 90% power.

Smaller effects require more participants because they are harder to distinguish from random variation. These figures are especially sensitive to the observed effect, which is uncertain in a trial of this size. They should be read as planning illustrations rather than as evidence about the trial’s design quality or its chance of success.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.576; treatment proportion p₁ = 0.441; average p̄ = 0.508.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7070 = 1.3857.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.7005 = 0.5895.
4. n = (1.3857 + 0.5895)² / (-0.1356)² = 212.2, rounded up to 213 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 <- 0.576271186440678                          # control proportion
p1 <- 0.440677966101695                          # 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(2813551)
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 = 213 (80% power), 284 (90% power)
 75% of observed effect: n per arm = 378 (80% power), 505 (90% power)
 50% of observed effect: n per arm = 847 (80% power), 1,133 (90% power)
power.prop.test: 212.2 
Simulated power at n = 213 per arm: 0.793 (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.

14. Analyses Reported by the Sponsor

The registry’s own primary analysis reports a risk ratio of 0.76 with a 95% confidence interval from 0.53 to 1.10. This estimate is the sponsor-reported result and should be distinguished from the simple unadjusted recalculation from the posted event counts. The recalculation expresses the comparison as a risk difference and gives an unadjusted p-value of 0.141; it is not a replacement for an undocumented sponsor method.

The sponsor interval includes 1, the null value for a risk ratio. The recalculated risk-difference interval includes zero, the null value on that scale. Both summaries therefore indicate uncertainty that includes no group difference. The sponsor analysis does not report a p-value in the registry record. The registry’s discrepancy indicator is false, so no disagreement between the sponsor-reported result and the recalculated summary is flagged.

The sponsor’s estimate should be treated as the primary reported analysis because it is the analysis entered in the registry. The record does not state the statistical method used to obtain it, whether it was adjusted, or whether additional prespecified analyses were performed. The recalculation is useful as a transparent description based on the posted counts, but it cannot recover details that the registry does not report.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies the primary outcome and labels its analysis population intention-to-treat. It also lists multiple secondary outcomes. However, the statistical analysis plan, the method used for the primary comparison, and any planned adjustment for multiple testing are not reported in the registry record. It is therefore not possible to determine from the record whether the primary analysis followed a prespecified model or whether secondary results were adjusted or ordered for confirmatory interpretation.

General explanation: multiplicity arises when several hypotheses or outcomes are tested. Without an adjustment or a clear testing hierarchy, the chance of at least one false-positive result across a collection of tests can be greater than the chance for a single test. This concern is particularly relevant when secondary outcomes are interpreted separately. It does not invalidate the measurements, but it makes isolated secondary findings less conclusive.

The intention-to-treat label indicates that the primary population is described as based on assigned groups, but it does not explain how missing outcome measurements were handled. The registry does not report the number of missing primary measurements, imputation methods, exclusions after randomization, or sensitivity analyses. It also does not describe adherence or crossover handling. These omissions limit assessment of how complete the outcome data were and how robust the estimate might be to alternative missing-data assumptions.

Allocation concealment, the randomization sequence method, the masked roles, and protocol deviations are not reported in the registry record. The registry also does not describe interim analyses or stopping rules. None of these unreported details should be inferred from the randomized or quadruple-masked labels alone. Their absence from the registry record does not prove that the procedures were not used; it means their use and details cannot be evaluated from this record.

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.

Most frequent non-serious adverse event terms

The adverse-event record reports zero serious adverse events in the torsemide group and zero in the placebo group, with 59 participants at risk in each group. It reports other adverse events affecting 2 participants in the torsemide group and 4 in the placebo group. Deaths are recorded as zero in both groups. No top serious adverse-event terms are listed.

These counts describe what is entered in the registry, not the full clinical context of each event. The record does not provide event descriptions, severity details for the other adverse events, attribution to treatment, timing, duration, or a safety-analysis method. The adverse-event reporting timeframe is not specified in the posted safety fields. A zero serious-event count in these groups does not establish that a treatment is free of risk, particularly when the record does not provide detailed event-level information or longer-term safety follow-up.

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

The results show that fewer participants in the torsemide group met the primary hypertension endpoint than in the placebo group during the defined early postpartum period. The sponsor-reported risk ratio is below 1, but its 95% confidence interval includes 1. The unadjusted recalculated comparison also has an interval that includes no difference. Together, these findings describe a direction in the observed data while leaving substantial uncertainty about the underlying group difference.

The result does not prove that torsemide reduces persistent postpartum hypertension, nor does it prove that it has no effect. A nonsignificant result is not a demonstration of equivalence. The record does not state a clinical equivalence margin, a minimum important difference, or a target effect that would distinguish a clinically meaningful change from a trivial one. Statistical uncertainty and clinical importance are related but different considerations.

The primary outcome is limited to a threshold-based measure assessed by postpartum day 5 or discharge, whichever occurred first. It does not establish what happened after that window, describe all blood-pressure trajectories, or answer questions about outcomes that were only listed as secondary measures. The group counts also do not establish that any observed difference was caused by treatment; randomized comparisons support causal interpretation when design, conduct, outcome ascertainment, and analysis are adequately implemented, and several of those details are not reported in the registry record.

The findings should be understood in the context of a phase 2 trial and the posted sample size. The registry’s planning illustrations use the observed effect and do not establish the original design rationale. Additional well-described evidence would be needed to clarify the size and precision of any effect and to assess the broader clinical and safety questions. No treatment recommendation follows from this statistical interpretation.

18. Why This Trial Matters Statistically

This trial illustrates why a point estimate should not be read on its own. The observed primary counts are directionally different, and the sponsor’s risk-ratio estimate is below 1, but the confidence interval includes the null value. The central estimate describes one plausible summary of the data; its uncertainty is essential to judging what conclusions the data can support.

It also shows how the scale of a comparison shapes interpretation. A risk ratio describes relative event risk, while a risk difference describes an absolute contrast in event proportions. They express the same binary outcome in different ways. Neither scale removes uncertainty, and neither should be confused with proof of clinical importance. The endpoint definition and assessment window remain central to the meaning of either estimate.

The trial’s planning illustrations highlight the relationship between effect size and information needs. Smaller target effects require more participants under the stated planning assumptions. Because those illustrations use the observed effect, they are not a substitute for the trial’s original design justification and should not be interpreted as observed power.

Finally, the record makes clear why analysis details matter. The registry reports the sponsor’s estimate but not its method, and it does not report multiplicity procedures, missing-data handling, or a full analysis plan. Those omissions constrain independent evaluation even when group counts and a confidence interval are available. Clear reporting of design assumptions, analysis choices, and uncertainty is necessary for readers to judge how strongly a clinical trial supports its conclusions.

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 registry record leaves important design and analysis details unspecified. It does not report the original sample-size justification, the statistical analysis plan, the method used for the sponsor’s risk-ratio estimate, or whether that analysis was adjusted. The recalculated comparison is unadjusted and cannot reproduce unreported modeling choices.

The primary endpoint uses a blood-pressure threshold and a short assessment period ending by postpartum day 5 or at discharge, whichever occurred first. This definition does not capture the full course of blood pressure or outcomes after that interval. The registry separately lists persistent hypertension using a different threshold, so the primary and secondary definitions should not be treated as equivalent.

Missing-data counts and handling are not reported in the registry record. Nor are adherence, treatment discontinuation, crossover, protocol deviations, or sensitivity analyses described. The intention-to-treat label alone does not resolve how unavailable measurements were treated. The record also does not identify which roles were masked or describe allocation concealment.

Multiple secondary outcomes are listed, but a multiplicity plan is not reported. Some listed outcomes do not have numerical results in the posted results, and the registry does not explain the status of each absent result. The safety record gives counts but not event descriptions, attribution, or a timeframe. These limitations do not determine what happened; they restrict what can be assessed from the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: ToRsemide for pOstpartum HYpertension — NCT02813551.
• Registry record last updated 2019-04-10; status last verified 2019-03.
• Results first posted 2019-04-10.
• 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.

23. Record Summary

NCT02813551 is a completed randomized, quadruple-masked, parallel-group phase 2 trial sponsored by The University of Texas Health Science Center, Houston. It compared torsemide 20 mg daily for 5 days with placebo 20 mg daily for 5 days in women with preeclampsia. The primary endpoint counted participants with persistent postpartum hypertension, defined by sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or discharge, whichever occurred first.

The posted primary counts were 26 of 59 in the torsemide group and 34 of 59 in the placebo group. The sponsor-reported risk ratio was 0.76, with a 95% confidence interval from 0.53 to 1.10. The interval includes 1, so the estimate remains uncertain about whether the groups differed. The registry does not report several details needed to fully assess the analysis, including its method, missing-data handling, and multiplicity procedures.