At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 48 enrolled
Drug / intervention
Nitrous Oxide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial of Nitrous Oxide Analgesia in External Cephalic Version (ECV)
In Brief
A Phase 3 clinical trial evaluating Nitrous Oxide and Placebo for External Cephalic Version. Completed, enrolled 48 participants across 1 site.
Detailed Summary
This study seeks to determine the effectiveness of nitrous oxide in reducing the anxiety and pain associated with external cephalic version (ECV); a maneuver to turn the fetus from breech to cephalic position.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExternal Cephalic Version
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJan 2017
First PostedApr 2018
Primary CompletionFeb 2019
TodayJul 2026
First PostedApr 19, 2018
Enrollment StartJan 30, 2017
Primary CompletionFeb 14, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.2 years ago
Interventions
Nitrous Oxidedrug
50% nitrous oxide/50% oxygen via Nitronox delivery device
Placeboother
100% oxygen via Nitronox delivery device