Comparison · NCT01004029-7fed5651
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Fetal/Early Infant Death
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. 17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: Fetal/Early Infant Death. Trial comparisons, record NCT01004029-7fed5651. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01004029-7fed5651
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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 | 0.0168 | 0.0108 | 0.0261 | wilson | |
| Risk in group 2 | 0.019 | 0.0107 | 0.0338 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00222 | -0.0181 | 0.0103 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.884 | 0.423 | 1.84 | log | |
| Odds ratio, group 1 over group 2 | 0.882 | 0.417 | 1.87 | log | |
| Number needed to treat, for one fewer participant with the outcome on 17P (Hydroxyprogesterone Caproate Injection) than on Vehicle | 451 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 17P (Hydroxyprogesterone Caproate Injection) | HPC 250 mg/mL in oil~Hydroxyprogesterone Caproate Injection, 250mg/mL: 1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first. | 19 | 1,130 | OG001 |
| Group 2 | Vehicle | Castor Oil~Vehicle: Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first. | 11 | 578 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Fetal/Early Infant Death
- Description
Defined as spontaneous abortion/miscarriage (delivery from 16 weeks 0 days through 19 weeks 6 days of gestation) or neonatal death occurring in liveborns born at less than 24 weeks gestation or stillbirth (antepartum or intrapartum death from 20 weeks gestation through term), in the 17P group compared to the vehicle group
- Time frame
Delivery from 16 weeks 0 days through 19 weeks 6 days of gestation; or neonatal death occurring in liveborns born at less than 24 weeks gestation; or stillbirth (antepartum or intrapartum death) from 20 weeks gestation through term).
- Population
- Intent to Treat (ITT) Population - all randomized subjects regardless of whether they received study medication.
Source ClinicalTrials.gov
Trial
- Title
- Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
- NCT number
- NCT01004029
- Phases
- PHASE3
- Conditions
- Preterm Birth
- Interventions
- Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL, Vehicle
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Results first posted
- 2021-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01004029?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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