Comparison · NCT00615550-sae
Prochieve vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Prochieve vs Placebo: serious adverse events. Trial comparisons, record NCT00615550-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00615550-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.413 | 0.352 | 0.477 | wilson | |
| Risk in group 2 | 0.438 | 0.374 | 0.503 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0247 | -0.114 | 0.0652 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.943 | 0.763 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.904 | 0.624 | 1.31 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Prochieve than on Placebo | 40.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Prochieve | Progesterone 8% Vaginal Gel | 97 | 235 | EG001 |
| Group 2 | Placebo | placebo vaginal gel | 98 | 224 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomization to delivery (1 day to 168 days)
Source ClinicalTrials.gov
Trial
- Title
- PREGNANT Short Cervix Trial
- NCT number
- NCT00615550
- Phases
- PHASE3
- Conditions
- Preterm Delivery, Short Cervix, Short Uterine Cervical Length
- Interventions
- progesterone, placebo
- Lead sponsor
- Juniper Pharmaceuticals, Inc.
- Results first posted
- 2012-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00615550?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00615550-sae