Phase 3
N=48
Nitrous Oxide for External Cephalic Version
External Cephalic Version
Bottom Line
View on ClinicalTrials.gov: NCT03502915 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Mean Pain Score Experienced During Version — 5.486; 5.433 score on a scale — p=0.943
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nitrous Oxide (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Score Experienced During Version |
5.486; 5.433 | 0.943 |
| SECONDARY Mean Anxiety Score Experienced During Version |
4.696; 4.253 | 0.597 |
| SECONDARY Mean Post-procedure Pain Score |
1; 0.88 | 0.748 |
| SECONDARY Mean Post-procedure Patient Satisfaction Score |
4.286; 6.920 | 0.025 sig |
| SECONDARY Mean Post-procedure Provider Assessed Level of Difficulty Score |
6.136; 6.080 | 0.944 |
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.
Eligibility Criteria
Inclusion Criteria
- Female 18 years or greater
- Scheduled to undergo external cephalic version due to singleton breech presentation
- Not scheduled to have spinal or epidural anesthesia during the version procedure
- American Society of Anesthesiology (ASA) Physical Status 1, 2 or 3.
- Able to provide informed consent and adhere to study protocol
Exclusion Criteria
- Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of exposure to nitrous oxide or complicate the subject's post-procedural course.
- Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
Data sourced from ClinicalTrials.gov (NCT03502915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.