This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days (NCT05819619), a randomized early/phase 1 study. The primary outcome is Patient Satisfaction.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05819619 |
| Phase | EARLY/Phase 1 |
| Condition | Nausea, Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hackensack Meridian Health |
| Results posted | Yes |
2. Clinical Question
Population
The registry record concerns people receiving medical abortion treatment, with the listed trial title specifying treatment before 70 days. Further eligibility details and a fuller description of the study population are not reported in the registry record.
Intervention
The prophylactic arm administered ibuprofen and ondansetron at the time of misoprostol administration. The proposed clinical question was whether this preventive regimen could reduce side effects and increase patient satisfaction.
Comparator
The standard-of-care arm used ibuprofen or ondansetron only when pain or nausea, respectively, was experienced after misoprostol administration. The comparison therefore concerns medication timing as well as a prophylactic versus symptom-triggered approach.
Primary question
At a follow-up visit within 2 weeks of misoprostol administration, did the prophylactic regimen affect patient satisfaction, assessed with a home-developed survey using a 5-Likert scale from Very satisfied to Very dissatisfied? The registry record reports no analysis or result answering this question.
3. Trial Design
The study is listed as a randomized, parallel-group trial with no masking. One group received prophylactic ibuprofen and ondansetron at the time of misoprostol administration. The comparator group received ibuprofen or ondansetron only when experiencing pain or nausea, respectively, after misoprostol. Because masking is listed as none, the registry record does not describe a masked comparison.
The record lists an enrollment of 8 and an early phase 1 designation. Its status is terminated. The recorded study start is 2023-07-20, and the primary completion date is 2024-04-01. The reason for termination and the timing or circumstances of that decision are not reported in the registry record. The record also does not explain whether the enrollment figure represents everyone who began the intervention or everyone with follow-up data.
The primary outcome is patient satisfaction at a follow-up visit within 2 weeks from misoprostol administration. Listed secondary outcomes concern pain management at 6-8 hours and 24 hours, nausea management, and need for pain-management or anti-nausea medication. Nausea management appears twice in the secondary-outcome listing. The record lists 8 outcome measures, but does not give outcome results or explain how each measure was analyzed.
Randomization can help make treatment groups comparable on average, but it does not ensure comparability in a very small trial. The registry record does not report the sequence-generation method, allocation concealment, eligibility criteria, or details about adherence and follow-up. Those omissions limit assessment of how the assigned regimens were implemented and how complete the outcome data were.
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
| Stage | Standard of Care | Prophylactic Use |
|---|---|---|
| STARTED | 3 | 5 |
| COMPLETED | 0 | 3 |
| NOT COMPLETED | 3 | 2 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Standard of Care | Prophylactic Use | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 5 | 8 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 | 5 | 8 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 29 (21 to 41) | 29 (22 to 38) | 29 (21 to 41) |
| Sex: Female, Male: Female | Participants | 3 | 5 | 8 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 2 | 2 | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Hispanic/Latino | Participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Non Hispanic/Latino | Participants | 1 | 2 | 3 |
| Race/Ethnicity, Customized: Other- Hispanic/Latino Hispanic/Latino | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Central or South American | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Cuban | Participants | 1 | 0 | 1 |
| Region of Enrollment: United States | participants | 3 | 5 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Patient Satisfaction, measured over At follow up visit, within 2 weeks from the administration of misoprostol.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is patient satisfaction, measured at a follow-up visit within 2 weeks after misoprostol administration. The registry describes a home-developed survey with a 5-Likert scale ranging from Very satisfied to Very dissatisfied. It frames the purpose as determining whether prophylactic ondansetron and ibuprofen can increase satisfaction and create a more favorable outcome.
Satisfaction is a patient-reported outcome: it captures a participant’s evaluation of the experience rather than a clinical event alone. That can be relevant when comparing a preventive medication schedule with symptom-triggered medication use. The scale has ordered response categories, so an analysis needs to make clear how those categories are represented. The registry record does not report the scoring method, whether responses were combined into categories, or how the endpoint was intended to be summarized.
No primary-outcome values or comparison are reported in the registry record. It therefore does not establish how participants responded, whether responses differed between groups, or how precisely any difference was estimated. The record also does not report a threshold for a meaningful change in satisfaction.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison but does not report a primary-outcome analysis. It lists patient satisfaction as the primary endpoint and identifies a follow-up visit within 2 weeks of misoprostol administration as the assessment time. However, no satisfaction responses, group summaries, treatment-effect estimate, or uncertainty measure are reported. The record therefore cannot show whether satisfaction differed between the prophylactic and symptom-triggered approaches.
The enrollment listed is 8. That small enrollment makes it especially important to distinguish the trial’s recorded size from evidence about the size or precision of any treatment effect. In this record, no effect estimate is available to interpret. A lack of a reported comparison is not evidence that the groups had the same experience, and it is not evidence that either regimen did or did not affect satisfaction.
The study status is terminated, but the reason for termination is not reported in the registry record. The record does not say whether termination affected recruitment, intervention delivery, follow-up, or the planned analysis. Nor does it report whether the participants represented by the enrollment figure completed the satisfaction survey. These unknowns prevent a direct assessment of completeness and potential bias in the primary endpoint.
Eight outcome measures are listed, including pain and nausea management outcomes and medication use. The record gives no outcome results for these measures. The list also repeats nausea management, and does not explain whether the entries refer to distinct definitions or assessments. Consequently, no clinical pattern across the outcomes can be inferred from their names alone.
The registry safety figures list zero serious events, zero other events, and zero deaths in each group’s reported at-risk set. These are event counts, not comparative estimates of safety, and the record does not give event definitions or further context about collection. With no outcome analysis reported, the figures should be interpreted narrowly as the recorded counts, not as proof that adverse events cannot occur.
Any sample-size illustrations associated with this analysis are planning scenarios, not observed power. They are described as using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such illustrations depend on their assumptions and do not supply a missing trial result. The registry record does not report an analysis of the primary endpoint from which an effect or its precision could be evaluated.
9. Statistical Methods Explained
What does the randomization describe?
Randomized allocation means the trial assigned participants to the prophylactic regimen or the symptom-triggered regimen by chance. In general, randomization is intended to reduce systematic differences between groups at the point of assignment. It does not guarantee balance in every characteristic, particularly in a small trial, and it does not by itself address missing outcomes or differences in how treatment is delivered.
The record identifies the design as parallel and unmasked. A parallel design compares groups assigned to different approaches over the same study period rather than describing participants as crossing between regimens. No masking means the record does not report concealment of the assigned approach from participants or study personnel. The sequence-generation and allocation-concealment procedures are not reported in the registry record, so the operational details of randomization cannot be evaluated.
How should the satisfaction scale be understood?
The primary outcome uses a 5-Likert scale with responses ranging from Very satisfied to Very dissatisfied. In general, Likert responses are ordered categories: the order carries meaning, but the distance between neighboring response options is not automatically known to be equal. Analyses can summarize the response distribution, use a prespecified score, or apply a model suited to ordered categories. The appropriate choice depends on the protocol and analysis plan.
The registry record does not report the scoring rule, category-collapsing decisions, or statistical model. It also does not report the number of responses in each category. Without those details and results, there is no basis to calculate or interpret a group contrast. The trial’s stated aim of increasing satisfaction is not itself evidence that satisfaction increased.
What does an estimate and its uncertainty usually convey?
In general, a treatment-effect estimate describes the observed contrast between groups on a defined outcome. A confidence interval describes the range of values reasonably compatible with the data and the statistical model, under the method used. A narrow interval indicates greater precision than a wide interval, but neither an interval nor a point estimate establishes clinical importance without relevant context.
No estimate or confidence interval for satisfaction is reported in the registry record. No p-value or primary-outcome analysis is listed either. It is therefore not possible to judge statistical compatibility with a null effect, the precision of an effect estimate, or whether any difference would be meaningful to participants. The record does not report a prespecified threshold for clinical importance.
Why can over-dispersion matter?
As a general statistical concept, over-dispersion occurs when count data vary more than a chosen model expects. A model that assumes less variability than the data contain can understate uncertainty and make results appear more precise than they are. Methods for count outcomes may account for over-dispersion when the data and study design support that approach. The registry record does not report a count-outcome model or dispersion estimate, and no outcome analysis is listed. Over-dispersion therefore cannot be assessed for this trial from the registry record.
How should planning calculations be read?
The planning illustrations are described as calculations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. They are illustrations of sample sizes under stated assumptions; they are not observed power and do not demonstrate that the trial had a particular probability of detecting an effect. A planning calculation cannot substitute for an analysis of the trial’s outcomes.
Such calculations depend on the chosen effect to detect, the outcome’s variability or event frequency, and the statistical method. A smaller effect generally requires more information to distinguish it from random variation, while greater variability also makes precise estimation harder. These are general principles, not findings from this trial. The registry record does not report a sample-size justification, the protocol’s design assumptions, or a completed primary-outcome analysis. Because no primary effect estimate is reported, the illustrations should not be interpreted as validation of the study’s enrollment or as evidence about efficacy.
For time-to-event outcomes, the record’s planning description refers to total event counts using the Schoenfeld approach; for other outcomes, it refers to participants per arm. Those are different planning quantities. No time-to-event primary outcome is identified in the registry record, and the primary endpoint is patient satisfaction. The planning conventions do not provide a result for that endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists patient satisfaction as the primary outcome and 8 outcome measures overall. Several secondary outcomes concern pain management, nausea management, and medication use; nausea management is repeated in the listing. When a study examines multiple outcomes or multiple assessments, the chance of at least one apparently notable finding can increase. Statistical plans may address this multiplicity by defining a primary comparison, adjusting inference, or treating secondary findings as exploratory. This is a general consideration, not a description of a method used in this trial.
A multiplicity strategy is not reported in the registry record. The record also does not report a hierarchy among the secondary outcomes, how the repeated nausea-management entries differ, or whether there were additional planned analyses. It lists no analyses. With no outcome results or analysis plan available, the impact of multiplicity on interpretation cannot be assessed.
Missing-data methods, follow-up completion, and the analysis population are not reported in the registry record. It is unknown whether the primary endpoint was analyzed for all randomized participants, only participants who completed follow-up, or another group. The record does not state how missing survey responses or incomplete symptom assessments were handled. These details matter because missingness can affect both the representativeness of the analyzed participants and the uncertainty of the estimates.
The terminated status does not by itself explain whether data are missing or how analyses were affected. The reason for termination and any changes to the analysis plan are not reported in the registry record. Consequently, the available information does not support a judgment about the completeness, multiplicity control, or population used for an outcome analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Standard of Care | 0 | 3 | 0.0% |
| Prophylactic Use | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard of Care | 0 of 3 |
| Prophylactic Use | 0 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Standard of Care | 0 of 3 |
| Prophylactic Use | 0 of 5 |
The registry safety record lists a Standard of Care group with 3 participants at risk and a Prophylactic Use group with 5 participants at risk. For each group, the listed count of participants with a serious event is 0, the count with other events is 0, and deaths are 0. These are the recorded counts for the groups and categories in the registry record.
Zero recorded events should not be read as proof that the regimens have no safety risks. In general, when few participants are observed, event counts may provide limited information about uncommon harms or the range of possible event rates. The registry record does not provide event definitions, a detailed event listing, follow-up duration for safety collection, or information about how events were solicited and classified. It also does not describe a formal comparative safety analysis.
The safety group counts should be kept distinct from the enrollment figure and from an estimate of treatment effect. The record reports no comparative risk estimate or uncertainty interval. The appropriate reading is therefore descriptive: no serious events, other events, or deaths are listed in either group’s reported safety counts.
12. What the Result Does, and Does Not, Mean
This record establishes that a randomized, unmasked, parallel-group trial was registered to compare prophylactic ibuprofen and ondansetron at misoprostol administration with medication use when pain or nausea arose. Its primary question concerned patient satisfaction at follow-up within 2 weeks. The record lists an enrollment of 8 and states that the study is terminated.
It does not establish whether the prophylactic regimen changed satisfaction, pain, nausea, medication use, or any other clinical outcome. No outcome values, primary comparison, effect estimate, or uncertainty interval are reported in the registry record. The stated research aim is not a result, and the existence of a randomized design does not make an unreported analysis available for interpretation.
The recorded safety counts are zero for serious events, other events, and deaths in each listed group. Those counts describe what is recorded; they do not show that risks are absent. The small enrollment and lack of detail about follow-up and event collection further limit what can be concluded from those counts.
Accordingly, the registry record is informative about the intended comparison and endpoint, but does not permit a conclusion about the direction, magnitude, or precision of a treatment effect. The reason for termination, analysis population, missing-data handling, and statistical analysis plan are not reported in the registry record. These gaps should remain distinct from evidence of no effect or evidence of safety.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that are important in clinical research. Its randomized, parallel design addresses a comparison between two medication-timing strategies, but its enrollment is listed as 8. With a small amount of information, estimates can be imprecise, and chance differences between groups can be substantial. The registry record does not report an outcome estimate, so the actual precision cannot be quantified.
The endpoint also requires careful treatment. Patient satisfaction is measured using ordered survey categories, and the registry does not report how those categories were scored or analyzed. Clear outcome definitions and a prespecified analysis are important because different summaries can answer different questions. A category distribution, a score, and a model-based contrast need not have the same interpretation.
Termination and absent analyses make transparent reporting especially relevant. The record does not explain why the study was terminated, whether the planned outcome assessments were completed, or how missing information was handled. It lists several outcomes, including a repeated nausea-management entry, but does not report a multiplicity plan. These details are essential for distinguishing prespecified findings from exploratory ones and for understanding which participants and outcomes contributed to an analysis.
The registry also illustrates the boundary between planning calculations and trial evidence. Sample-size illustrations can help describe what a study might detect under assumptions, but are not observed power and do not replace effect estimates with uncertainty. Without a reported primary analysis, the central statistical question remains unanswered in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record leaves important design and conduct details unavailable. Eligibility criteria, participant characteristics, recruitment procedures, randomization methods, allocation concealment, adherence, and masking details beyond no masking are not reported. The reason for the terminated status is also not reported. These omissions make it difficult to assess generalizability, implementation, and potential sources of bias.
No primary or secondary outcome results are reported, and the registry lists 0 analyses. The primary endpoint’s survey is described as home-developed, but its scoring rule, validation information, category handling, and missing-response procedures are not reported. The record also does not explain how the repeated nausea-management entry relates to the other listed outcomes.
Follow-up completeness and the analysis population are not reported. It is not possible to determine whether the enrollment figure corresponds to participants with completed satisfaction assessments or whether all randomized participants were included in outcome analyses. The reason for termination and any effect on recruitment or follow-up are unknown.
Finally, the record does not report a statistical analysis plan, sample-size justification, multiplicity strategy, or a threshold for a meaningful satisfaction difference. The safety counts contain no listed events, but event definitions and collection details are not reported. These limitations prevent a reliable estimate of the comparative effects or a detailed assessment of safety from the registry record alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days — NCT05819619.
- Registry record last updated 2025-11-17; status last verified 2025-11.
- Results first posted 2025-11-17.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes an early phase 1, randomized, unmasked, parallel-group study of prophylactic ibuprofen and ondansetron versus symptom-triggered use after misoprostol administration. Enrollment is listed as 8; study status is terminated. The recorded start date is 2023-07-20, and the primary completion date is 2024-04-01.
Patient satisfaction at a follow-up visit within 2 weeks is the primary outcome, measured with a home-developed 5-Likert survey. The record lists 8 outcome measures and 0 analyses. No primary or secondary outcome results are reported. The reason for termination, analysis population, missing-data approach, and statistical analysis plan are not reported in the registry record.
Safety counts list zero serious events, zero other events, and zero deaths in each group. These counts are descriptive and do not establish the absence of risk or provide a comparative safety estimate.