Nitrous Oxide for External Cephalic Version

Completed · Phase 3 · Has a placebo group

Conditions studied: External Cephalic Version

In brief

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.

Key facts

Study ID

NCT03502915

Run by

University of North Carolina, Chapel Hill

People needed

48

Starts

2017-01-30

Expected to finish

2019-02-14

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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