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Nitrous Oxide for External Cephalic Version

NCT03502915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-10-30

Study results available
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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.

Conditions

  • External Cephalic Version

Interventions

DRUG

Nitrous Oxide

50% nitrous oxide/50% oxygen via Nitronox delivery device

OTHER

Placebo

100% oxygen via Nitronox delivery device

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Kathleen A. Smith, MD, FASA · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2019-02-14
Completion
2019-02-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502915 on ClinicalTrials.gov