Comparison · NCT01127581-sae
MVI 200 vs Dinoprostone Vaginal Insert (DVI): 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. MVI 200 vs Dinoprostone Vaginal Insert (DVI): serious adverse events. Trial comparisons, record NCT01127581-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01127581-sae
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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 | 0.192 | 0.164 | 0.223 | wilson | |
| Risk in group 2 | 0.157 | 0.132 | 0.187 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0344 | -0.00603 | 0.0747 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 0.966 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 1.27 | 0.959 | 1.68 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MVI 200 than on Dinoprostone Vaginal Insert (DVI) | 29.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | MVI 200 | MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. | 130 | 678 | EG000 |
| Group 2 | Dinoprostone Vaginal Insert (DVI) | 10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. | 107 | 680 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All adverse events were followed until resolution or at least 30 days after discontinuation of the study drug, whichever occurred first.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
- NCT number
- NCT01127581
- Phases
- PHASE3
- Conditions
- Reducing Time to Vaginal Delivery, Cervical Ripening, Induction of Labor
- Interventions
- MVI 200, Dinoprostone Vaginal Insert (DVI)
- Lead sponsor
- Ferring Pharmaceuticals
- Results first posted
- 2014-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01127581?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.
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