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

Phase 3

Completed

• Conditions: Breech Presentation in Pregnancy
• Interventions: Drug: equimolar mixture of oxygen and nitrous oxide or medical air

• Registration Number: NCT01948115
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-15
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Study Start: 2013-11
• Status Verified: 2015-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical air	equimolar mixture of oxygen and nitrous oxide or medical air	-
equimolar mixture of oxygen and nitrous oxide	equimolar mixture of oxygen and nitrous oxide or medical air	-

Primary Outcome Measures

Name	Time	Method
Number of women with success after ECV	20 minutes	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

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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France