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

Primary Purpose

Breech Presentation in Pregnancy

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
equimolar mixture of oxygen and nitrous oxide or medical air
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation in Pregnancy focused on measuring Breech presentation, equimolar mixture of oxygen and nitrous oxide, external cephalic version

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Medical air

equimolar mixture of oxygen and nitrous oxide

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain during ECV
Just after ECV: pain during ECV with Visual Analogue Scale
Frequency of nausea/vomiting
Just after ECV: Frequency of nausea / vomiting between the two groups
Number of interrupted procedures
Just after ECV: number of interrupted procedures due to pain
Number of cephalic presentation at birth
At birth: rate of cephalic presentation between the two groups
Number of cesarean at birth
At birth: cesarean rate between the two groups

Full Information

First Posted
September 15, 2013
Last Updated
December 17, 2015
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01948115
Brief Title
Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV)
Acronym
MEOREV
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation in Pregnancy
Keywords
Breech presentation, equimolar mixture of oxygen and nitrous oxide, external cephalic version

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical air
Arm Type
Placebo Comparator
Arm Title
equimolar mixture of oxygen and nitrous oxide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
equimolar mixture of oxygen and nitrous oxide or medical air
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of women with success after ECV
Description
Success rate just after ECV between the two groups (equimolar mixture of oxygen and nitrous oxide group, and medical air group) with ultrasound.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Pain during ECV
Description
Just after ECV: pain during ECV with Visual Analogue Scale
Time Frame
20 minutes
Title
Frequency of nausea/vomiting
Description
Just after ECV: Frequency of nausea / vomiting between the two groups
Time Frame
1 hour
Title
Number of interrupted procedures
Description
Just after ECV: number of interrupted procedures due to pain
Time Frame
20 minutes
Title
Number of cephalic presentation at birth
Description
At birth: rate of cephalic presentation between the two groups
Time Frame
2 month
Title
Number of cesarean at birth
Description
At birth: cesarean rate between the two groups
Time Frame
2 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie ESBELIN, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31630398
Citation
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.
Results Reference
derived

Learn more about this trial

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

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