Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk (NCT06276647), a randomized na study. The primary outcome is Emergency Department (ED) Visits and Readmissions.

2. Clinical Question

This is a pilot randomized control trial, according to its official title. Its stated aim is to develop a system for improving postpartum care for patients considered at high need. The central statistical question is therefore both descriptive and comparative: what hospital-use counts were recorded in the two randomized groups, and do the posted results permit a reliable estimate of the difference between them? For the primary outcome, the registry record gives group counts but no confidence interval or test. Secondary outcomes have posted unadjusted comparisons, which are useful for describing patterns but warrant cautious interpretation.

3. Trial Design

The registry record identifies NCT06276647 as a randomized, parallel-group trial with no masking. The study is marked completed. Enrollment was 220, with 110 participants in the standard postpartum care group and 110 in the intervention group. The record lists the condition areas as maternal behavior and postpartum depression. The phase is listed as not applicable.

The intervention is named HOME in the intervention listing and is categorized as behavioral. The arm description identifies a patient education pamphlet and partner sheet, while the study summary also describes access to a patient navigator during the first 30 days postpartum. Standard postpartum care was the control condition. No further allocation procedures, concealment methods, or details of masking are reported in the registry record.

The recorded study start date is 2024-02-20, and primary completion is dated 2025-06-06. These dates describe the registry timeline; they do not establish when each participant enrolled or completed follow-up. The primary outcome’s timeframe is 1-30 days postpartum. The secondary outcome for ability to obtain needed services uses the same timeframe, while depressive symptoms are listed for 1 day-6 months postpartum.

Random allocation and equal numbers assigned to the two groups support a direct comparison in principle. However, interpretation depends on how outcomes were defined, how follow-up was completed, and how the analysis handled missing information. Those details are not reported in the registry record. The record also does not describe a sample-size justification or the trial’s prespecified statistical analysis plan. The posted planning illustrations are distinct from the trial’s design justification and should not be read as evidence that the trial was designed for a particular power target.

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

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 Emergency Department (ED) Visits and Readmissions, measured over 1-30 days postpartum.

The primary endpoint is the number of emergency department visits and hospital readmissions during 1-30 days postpartum. The registry record says chart reviews were used to obtain information on these outcomes. It frames this measure as an indicator of postpartum morbidity and mortality and as a way to assess whether patients receive needed care outside emergency or inpatient settings.

Hospital use is relevant to the trial’s stated question because the study aims to improve access to needed services and timely provider contact, which the record describes as possible pathways for avoiding unnecessary emergency visits. Counting visits and readmissions gives a direct measure of recorded hospital use during the defined follow-up window. However, the registry record does not report whether visits and readmissions were counted separately, how repeat events were handled, or whether the primary measure was a combined count with specific rules. Those endpoint-definition details are not reported in the registry record.

The posted primary values are 18 for standard postpartum care and 21 for the intervention group, with 110 participants in each arm. These are group counts, not a reported estimate of the difference with uncertainty. The record does not post a confidence interval or inferential test for this primary count outcome. Without those results, the counts alone cannot show how precisely the groups differ or whether the observed difference is distinguishable from chance variation.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry reports a randomized parallel-group design, and the outcome results are presented by assigned group. Randomization is intended to create groups that are comparable on average, including with respect to factors that were not measured. It does not guarantee that the realized groups are identical, particularly in a pilot study. Interpretation also depends on retention, outcome ascertainment, and the statistical analysis population, none of which is fully described in the registry record.

What does a confidence interval express?

A confidence interval describes the range of effect estimates that are reasonably compatible with the observed data under the statistical method used. It communicates precision as well as direction. A narrow interval indicates more precise estimation than a wide interval, while an interval that includes no difference indicates that the data do not rule out no group difference at the corresponding confidence level. This does not prove that there is no effect; it means the estimate remains uncertain. The posted secondary intervals include no difference and extend to values on both sides, so they do not identify a single precise effect.

How should a risk difference be read?

A risk difference compares the proportions of participants with an outcome in two groups by subtracting one group’s risk from the other’s. Positive and negative values indicate opposite directions according to the comparison convention. The posted risk differences are 0.055 for ability to obtain needed services and 0.045 for depressive symptoms. Their confidence intervals include no difference. The risk difference is an absolute measure, which can be useful for understanding the magnitude of a group contrast on the outcome scale. The registry does not report adjusted risk differences.

What do risk ratios and odds ratios add?

A risk ratio compares the outcome risks between groups as a ratio, while an odds ratio compares their odds. These relative measures use different scales from a risk difference, and their numerical values should not be interpreted as though they were absolute changes. The registry posts relative estimates for the secondary outcomes, but the corresponding uncertainty intervals are broad and include the null value for each ratio measure. This reinforces that the secondary comparisons are imprecise. These alternative measures do not overcome limitations in outcome ascertainment, missing-data handling, or unreported analysis choices.

Why distinguish an unadjusted p-value from an effect estimate?

A p-value measures how incompatible the observed data are with a specified null hypothesis under the assumptions of a test. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The unadjusted p-values posted for the secondary comparisons are 0.411 and 0.181. They do not provide evidence against the null at conventional thresholds, but they also do not establish no effect. The effect estimates and their confidence intervals provide information about direction and precision that a p-value alone cannot provide.

“Unadjusted” means the reported comparison is not described as controlling for other variables or for a family of multiple tests. Whether covariate adjustment was planned, and the specific model used, are not reported in the registry record. The record lists no reported analyses for the secondary outcomes. Therefore the posted unadjusted comparisons should not be treated as a complete account of the planned statistical analysis.

Why are the primary counts not enough for inference?

The primary endpoint is recorded as a number of visits and readmissions, but the registry posts only the values 18 and 21. It does not post a measure of variability, a confidence interval, or a test for this count outcome. Counts can have different statistical properties depending on their distribution and on whether participants can contribute multiple events. Over-dispersion is a general concern for count data: it occurs when variation exceeds what a simple count model expects and can make uncertainty estimates too small if the model does not account for it. The registry record does not report the distributional assumptions or an analysis method for the primary count endpoint, so it is not possible to assess how such issues were addressed.

For the secondary outcomes, the registry includes planning illustrations based on the observed effects. Under the stated planning assumptions, the illustrations give participants per arm for 80% and 90% power at the listed fractions of the observed effect. They assume a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are planning illustrations, not observed power and not the trial’s own sample-size justification. The sample-size justification for the trial is not reported in the registry record. Planning estimates that use observed effects can also be unstable because an effect estimated from a pilot sample may not represent the effect in a future study.

No sample-size illustration can replace an analysis of the trial results. Power is a design property under specified assumptions; it is not a retrospective probability that a particular finding is true. The posted calculations help illustrate how sample sizes would vary under different assumed effects, but the record does not report whether those assumptions were chosen before the trial or used to plan its enrollment.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome and two secondary outcomes, but it does not report a multiplicity plan. It is therefore unclear whether the investigators intended to control the overall chance of a false-positive finding across the outcomes, designate a hierarchy for testing, or treat the secondary results as exploratory. The posted secondary p-values are unadjusted. Their interpretation should account for the possibility of multiple testing rather than treating each comparison as an isolated confirmatory test.

Missing-data methods are not reported in the registry record. The posted group sizes are 110 per arm, but those assigned counts do not establish that every participant contributed complete outcome data. The record does not describe loss to follow-up, missing chart-review information, exclusions from analysis, imputation, or sensitivity analyses. It is also not reported whether the analyses followed an intention-to-treat approach or another analysis population. These omissions limit assessment of possible bias from incomplete follow-up or outcome ascertainment.

The record does not describe an interim analysis plan, stopping rules, or whether any interim looks at accumulating data occurred. These details are not reported in the registry record and should not be inferred from the completed status. Likewise, the specific primary statistical model and any covariate adjustment are not reported. Because the primary outcome is a count, details about recurrent events and model assumptions would be especially relevant to evaluating the analysis, but the registry does not provide them.

These reporting gaps do not demonstrate that the trial was conducted improperly. They mean that readers cannot determine from the registry record how multiplicity, missing information, analysis populations, or interim monitoring were handled. Transparent reporting of these decisions would be needed to evaluate the robustness of the posted estimates and to distinguish planned confirmatory analyses from exploratory ones.

11. 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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: death (1.8%).

The safety listing reports serious adverse events affecting 2 participants in the intervention group and 0 in standard postpartum care. Deaths are listed as 2 and 0, respectively. Other adverse events are listed for 33 and 39 participants, respectively. The registry also identifies Death as the top serious event term, at 1.8%. These are counts as recorded; they do not by themselves establish that the intervention caused or prevented any event.

Adverse-event counts require context about event definitions, severity grading, relatedness to the intervention, observation time, and how events were collected. Those details are not reported in the registry record. The listing does not explain whether serious events and deaths overlap, or whether every event was judged treatment-related. It also does not report a comparative statistical analysis of safety outcomes.

Because the groups each had 110 participants, the raw counts are presented against equal assigned group sizes, but the counts alone do not provide a complete safety comparison. Rare or serious events can be difficult to interpret in a pilot trial, and uncertainty may be substantial. The figures should be read as the registry’s recorded adverse-event information, not as evidence of a causal safety effect.

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

The registry record documents a randomized pilot trial comparing a postpartum support intervention with standard postpartum care. It reports primary hospital-use counts and unadjusted comparisons for two secondary outcomes. Those results offer a descriptive record of what was observed, but they do not establish a reliable primary treatment effect: no inferential comparison for the primary outcome is posted.

The secondary estimates are accompanied by confidence intervals that include no difference and allow effects in either direction. This means the results remain uncertain. It does not show that the approaches are equivalent, and it does not show that an apparent direction of effect is necessarily real. The unadjusted p-values likewise do not measure clinical importance or provide the probability that a finding is true.

The trial’s randomized design is an important strength for evaluating a group comparison, but randomization alone cannot resolve limitations in reporting and precision. The registry record does not explain missing-data handling, analysis populations, the primary count model, adjustment choices, or multiplicity procedures. The intervention description is also incomplete in the registry text. These uncertainties make it difficult to assess how robustly the posted outcomes represent the intended comparison.

The posted sample-size illustrations are useful only as planning scenarios under stated assumptions. They do not demonstrate that the completed trial had adequate power, and they are not observed power estimates. The trial’s original sample-size justification is not reported in the registry record.

Accordingly, the results are best regarded as preliminary evidence that can inform the design and reporting of future studies. They do not establish that the intervention reduces hospital use, improves access, or changes depressive symptoms. Nor do they establish that it has no effect. More complete outcome definitions, analysis details, and appropriately precise comparative results would be needed to draw stronger statistical conclusions.

13. Why This Trial Matters Statistically

This trial raises a statistically important question about how to evaluate a care intervention when the intended pathway and the primary outcome are related but not identical. The study aims to improve access to postpartum support and timely services, while its primary endpoint counts emergency department visits and readmissions. A change in service access may be relevant to hospital use, but the relationship between these outcomes needs to be evaluated rather than assumed.

The randomized, equal-allocation design gives the comparison a clear structure. At the same time, a pilot trial can have limited precision for outcomes that vary between participants or occur infrequently. The primary group counts are therefore not sufficient on their own: uncertainty estimates and a suitable analysis of the count outcome are needed to judge how much the observed values inform the underlying group contrast. Those primary inferential results are not reported in the registry record.

The study also illustrates why outcome reporting should make analysis choices visible. For count outcomes, readers need to know how repeat events are handled and what statistical assumptions are used. For secondary outcomes, they need to know which comparisons were planned and how multiple testing was addressed. Clear information about follow-up completeness and analysis populations is also essential to assessing potential bias.

Finally, planning illustrations based on observed effects can communicate how sample-size requirements depend on assumptions, but they should not be confused with the original design calculation or with retrospective power. Taken together, these issues make the trial statistically informative as a pilot and as a record of reporting needs, while limiting the strength of conclusions that can be drawn from the posted results.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations are specific to the available record for this trial. The most important is that the primary outcome is reported as group counts without a posted confidence interval, p-value, or other inferential comparison. The counts therefore describe observed hospital use but do not quantify the uncertainty in a group contrast. The primary endpoint’s exact counting rules are also not described: the registry does not explain whether emergency visits and readmissions were combined, how repeat events were handled, or whether events were attributed to individual participants in a particular way.

The intervention description is incomplete. The record names a patient education pamphlet and partner sheet and also describes a navigator in the study summary, but it does not provide a full account of intervention delivery, uptake, or fidelity. Details about the content of standard postpartum care are not reported in the registry record. This limits assessment of what the randomized groups received in practice.

Follow-up periods differ across the primary and secondary outcomes. The primary measure and ability-to-obtain-needed-services outcome cover 1-30 days postpartum, while depressive symptoms are listed for 1 day-6 months postpartum. The registry does not explain the assessment instruments, sources of data, or how missing information during these periods was handled. It also does not report analysis populations or adjustment methods.

The secondary comparisons are unadjusted, and there is no reported multiplicity plan. The trial is identified as a pilot, but its sample-size justification is not reported in the registry record. Finally, the safety listing lacks detail on event relatedness, ascertainment, and overlap among categories. Each of these limitations narrows what can be concluded from the posted results without negating the value of the trial’s randomized design.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk — NCT06276647.
• Registry record last updated 2026-04-07; status last verified 2026-01.
• Results first posted 2026-03-10.
• 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.

18. Record Summary

NCT06276647 is a completed randomized, parallel-group pilot trial with no masking, sponsored by the University of Pennsylvania. Enrollment was 220, with 110 participants in each group. The intervention included a patient education pamphlet and partner sheet; the study summary also describes access to a patient navigator. The comparison group received standard postpartum care.

The primary outcome was the number of emergency department visits and hospital readmissions during 1-30 days postpartum. The registry posts counts of 18 for standard postpartum care and 21 for the intervention group, but no inferential comparison for the primary outcome. Two secondary outcomes have unadjusted comparisons, both with confidence intervals that include no difference. Important details about missing data, analysis populations, multiplicity, and the primary statistical method are not reported in the registry record.