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

Prospective Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV) in Singleton Pregnancy in Breech Presentation at Term

The variety of breech presentation at term is about 3-4% of all births. Our study aims to assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some patients algic or relaxed, the success rate seems more important.

It's a single blind prospective randomized controlled study, comparing success rate of ECV after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).

We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we will give the patient a satisfaction questionnaire. We compare the success rate of ECV as primary outcome.

Study Overview

• Status: Completed
• Conditions: Breech Presentation in Pregnancy
• Intervention / Treatment: Drug: equimolar mixture of oxygen and nitrous oxide or medical air

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age ≥ 18 years
• pregnancy at term (≥36 weeks)
• singleton foetus in breech or transverse presentation
• acceptance of ECV
• signature of informed consent

Exclusion Criteria:

• contraindications of ECV: placenta praevia, obstacle praevia, multiple pregnancy, foetal death, foetal heart rhythm disorder, lack of amniotic fluid, HIV-positive patient
• contraindications of equimolar mixture of oxygen and nitrous oxide : patient who require pure oxygen ventilation, disorders of consciousness that impede the cooperation of the patient, pneumothorax, pulmonary embolism, ocular surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Medical air	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.
Experimental: equimolar mixture of oxygen and nitrous oxide	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women with success after ECV	Success rate just after ECV between the two groups (equimolar mixture of oxygen and nitrous oxide group, and medical air group) with ultrasound.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during ECV	Just after ECV: pain during ECV with Visual Analogue Scale	20 minutes
Frequency of nausea/vomiting	Just after ECV: Frequency of nausea / vomiting between the two groups	1 hour
Number of interrupted procedures	Just after ECV: number of interrupted procedures due to pain	20 minutes
Number of cephalic presentation at birth	At birth: rate of cephalic presentation between the two groups	2 month
Number of cesarean at birth	At birth: cesarean rate between the two groups	2 month

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Julie ESBELIN, Dr, Nantes University Hospital

Publications and helpful links

General Publications

• Dochez V, Esbelin J, Misbert E, Arthuis C, Drouard A, Badon V, Fenet O, Thubert T, Winer N. Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial. Acta Obstet Gynecol Scand. 2020 Mar;99(3):391-398. doi: 10.1111/aogs.13753. Epub 2019 Nov 18.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 15, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: external cephalic version; Breech presentation; equimolar mixture of oxygen and nitrous oxide
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Breech Presentation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: RC13_0254