NCT01948115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2.1 years

First QC Date

September 15, 2013

Last Update Submit

December 17, 2015

Conditions

Breech Presentation in Pregnancy

Keywords

Breech presentationequimolar mixture of oxygen and nitrous oxideexternal cephalic version

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pain during ECV

    20 minutes

  • Frequency of nausea/vomiting

    1 hour

  • Number of interrupted procedures

    20 minutes

  • Number of cephalic presentation at birth

    2 month

  • Number of cesarean at birth

    2 month

Study Arms (2)

Medical air

PLACEBO COMPARATOR
Drug: equimolar mixture of oxygen and nitrous oxide or medical air

equimolar mixture of oxygen and nitrous oxide

EXPERIMENTAL
Drug: equimolar mixture of oxygen and nitrous oxide or medical air

Interventions

equimolar mixture of oxygen and nitrous oxide or medical airDRUG

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.

Medical airequimolar mixture of oxygen and nitrous oxide

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 31630398DERIVED

MeSH Terms

Conditions

Breech Presentation

Interventions

Nitrous OxideAir

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Julie ESBELIN, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2013

First Posted

September 23, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-11

Locations

FR(1)