CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT03502915
NCT03502915Phase 3Completed

Randomized Controlled Trial of Nitrous Oxide Analgesia in External Cephalic Version (ECV)

University of North Carolina, Chapel Hill·interventional·Posted Apr 19, 2018·Updated Oct 30, 2019

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--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
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