Comparison · NCT03670836-714cd556
Dilapan Group vs Misoprostol Group: Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention
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. Dilapan Group vs Misoprostol Group: Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention. Trial comparisons, record NCT03670836-714cd556. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03670836-714cd556
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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 | 0.0596 | 0.0317 | 0.109 | wilson | |
| Risk in group 2 | 0.0526 | 0.0269 | 0.1 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00697 | -0.0484 | 0.063 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.449 | 2.86 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.428 | 3.04 | log | |
| Number needed to treat, for one more participant with the outcome on Dilapan Group than on Misoprostol Group | 143 | 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 | Dilapan Group | Patients who are randomized to receive Dilapan, will have 3-5 rods of Dilapan-S® inserted in their cervix by the supervising provider, under aseptic precautions with a speculum exam, either digitally or using a sponge forceps, as per manufacturer's recommendations. The Bishop score at the time of eligibility assessment and number of rods inserted will be recorded. Dilapan will be left in cervix for 12 hours. Patients will be allowed to ambulate, shower and have light meals as long as they meet the criteria based on institutional guidelines for intermittent fetal heart monitoring. Nothing per vagina including douching and no bathing is allowed.~Dilapan: Dilapan-S® is a mechanical method for cervical ripening using rods made of a patented hydrogel Aquacryl, it is marketed in form of rods of 3 and 4 mm diameter. It is FDA approved for cervical ripening. | 9 | 151 | OG000 |
| Group 2 | Misoprostol Group | Patients who are randomized to Misoprostol group, after the baseline assessment and a reassuring cardiotocograms (CTG) monitoring for 20 minutes to a maximum of 6 doses. All subjects will have continuous fetal monitoring. A dose will be held if patient is noted to have uterine tachysystole, hyperstimulation, fetal heart tracing abnormalities or 3 or more painful uterine contractions over a period of 10 minutes (indicating onset of labor). Administration of Misoprostol will be done by the nurse assigned to the patient.~Misoprostol: 25mcg of Misoprostol will be administered orally every 2 hours (maximum of 6 doses)~Misoprostol is a prostaglandin E1 analog approved for treatment and prevention of gastric ulcers. The use of Misoprostol appears to be safe and effective for induction of labor when used in low dose. | 8 | 152 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention
- Description
- This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
- Time frame
- From birth until two weeks after birth
- Population
- Intent to treat population
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Misoprostol Ripening Efficacy With Dilapan
- NCT number
- NCT03670836
- Phases
- PHASE4
- Conditions
- Labor Onset and Length Abnormalities, Induced; Birth
- Interventions
- Dilapan, Misoprostol
- Lead sponsor
- Columbia University
- Results first posted
- 2024-07-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03670836?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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