Phase 3
Completed N=48
Nitrous Oxide for External Cephalic Version
External Cephalic Version
Source: ClinicalTrials.gov NCT03502915 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Mean Pain Score Experienced During Version — 5.486; 5.433 score on a scale — p=0.943
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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. Informational only — not medical advice.