Comparison · NCT03407625-6bc50251
Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Neonatal Sepsis
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Foley Bulb Plus Oral Misoprostol vs Oral Misoprostol: Number of Participants With Neonatal Sepsis. Trial comparisons, record NCT03407625-6bc50251. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03407625-6bc50251
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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 | 0.00179 | 0.000491 | 0.0065 | wilson | |
| Risk in group 2 | 0.000901 | 0.000159 | 0.00509 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00089 | -0.00349 | 0.00566 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.99 | 0.18 | 21.9 | log | |
| Odds ratio, group 1 over group 2 | 1.99 | 0.18 | 22 | log | |
| Number needed to treat, for one more participant with the outcome on Foley Bulb Plus Oral Misoprostol than on Oral Misoprostol | 1,120 | 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 | Foley Bulb Plus Oral Misoprostol | Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Foley bulb plus Oral Misoprostol: Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States. | 2 | 1,117 | OG000 |
| Group 2 | Oral Misoprostol | Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.~Oral Misoprostol: Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol. | 1 | 1,110 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Neonatal Sepsis
- Description
- Neonatal bacteremia as defined by bacterial growth in blood cultures
- Time frame
- From time of birth until the time of discharge or up to 7 days of life, whichever comes first.
- Population
Source ClinicalTrials.gov
Trial
- Title
- Foley Bulb With Oral Misoprostol for Induction of Labor
- NCT number
- NCT03407625
- Phases
- NA
- Conditions
- Pregnancy, Labor, Induced
- Interventions
- Foley bulb plus Oral Misoprostol, Oral Misoprostol
- Lead sponsor
- University of Texas Southwestern Medical Center
- Results first posted
- 2020-11-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03407625?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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