Trial · NCT01127581
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Vaginal Delivery During the First Hospital Admission | Interval from study drug administration to vaginal delivery (average 24 hours) | Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored. | minutes | MEDIAN |
| PRIMARY | Incidence of Cesarean Delivery During the First Hospital Admission | Interval from study drug administration to cesarean delivery (average 24 hours) | Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event. | percentage of participants | NUMBER |
| SECONDARY | Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission | Interval from study drug administration to neonate delivery (average 24 hours) | Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge. | minutes | MEDIAN |
| SECONDARY | Time to Active Labor During the First Hospital Admission | Interval from study drug administration to active labor (average 12 hours) | Intention-to-Treat (ITT) population | minutes | MEDIAN |
| SECONDARY | Incidence of Pre-delivery Oxytocin During the First Hospital Admission | At least 30 minutes after study drug removal | Analysis population includes subjects who delivered during the first hospitalization. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Vaginal Delivery Within 12 Hours | Interval from study drug administration to vaginal delivery within 12 hours | Intention-to-Treat (ITT) population | percentage of participants | NUMBER |
| SECONDARY | Incidence of Any Delivery Within 24 Hours | Interval from study drug administration to delivery of neonate within 24 hours | Intention-to-Treat (ITT) Population | percentage of participants | NUMBER |
| SECONDARY | Incidence of Any Delivery Within 12 Hours | Interval from study drug administration to delivery of neonate within 12 hours | Intention-to-Treat (ITT) Population | percentage of participants | NUMBER |
| SECONDARY | Incidence of Vaginal Delivery Within 24 Hours | Interval from study drug administration to vaginal delivery within 24 hours | Intention-to-Treat (ITT) Population | percentage of participants | NUMBER |
| SECONDARY | Incidence of Vaginal Delivery | Interval from study drug administration to vaginal delivery (average 24 hours) | The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses. | percentage of participants | NUMBER |
| SECONDARY | Rate of Adverse Events | From study drug administration to hospital discharge (approximately 48-72 hours) | The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01127581/outcomes