NCT01948115View on ClinicalTrials.gov

Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV)

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Breech Presentation in Pregnancy
Interventions
DRUG

equimolar mixture of oxygen and nitrous oxide or medical air

"We need to include 150 patients for a period of 2 years. Patients will be randomized: 75 patients in each arm: 75 patients in group placebo (medical air), 75 patients in group treatment (equimolar mixture of oxygen and nitrous oxide).~Patients will be single-blind. The ECV be started at least 3 minutes after the start of administration. The maximum time of administration of the gas will be 15 minutes. Just after ECV, we compare success rate of intervention."

Trial Locations (1)

44093

Nantes University Hospital, Nantes

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT01948115 - Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV) | Biotech Hunter | Biotech Hunter