Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation

Phase 3

• Conditions: Breech Presentation
• Interventions: Drug: Midazolam; Drug: Bupivacaine

• Registration Number: NCT02801201
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-27
• Study Start: 2016-05-31
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08
• Primary Completion: 2019-10-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• age ≥ 18 years
• patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
• covered by a an insurance system
• signed contentment

Exclusion Criteria

Obstetric contraindications:

• placenta previa
• 3rd trimester bleeding
• suspicion of fetal anoxia
• patient has already received more than one caesarean section
• multi-fetal pregnancy
• HIV +
• anticoagulant therapy

Anesthesiologic contraindications:

• infection at the puncture site, systemic infection or severe sepsis
• intracranial hypertension
• uncompensated heart failure
• constitute or acquired coagulation abnormalities, including anticoagulant therapy with curative intent
• neuropathy with demyelination of nerve fibers in thrust or unstabilized during recovery
• syringomyelia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sedation	Midazolam	Midazolam : 0,10 mg/kg
spinal anesthesia	Bupivacaine	Bupivacain 10 mg

Primary Outcome Measures

Name	Time	Method
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation	24 hours

Secondary Outcome Measures

Name	Time	Method
occurrence of side events due to the manipulation itself	Day 0	cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
occurrence of side events due to anesthesia	Day 0	hypotension, maternal bradycardia, desaturation, nausea / vomiting, number of punctures greater than 1 (failure of the first puncture for spinal anesthesia leading to the necessity to perform one or more others).
The pain experienced by the patient: assessed by the Visual Analogic Scale	Day 0
The final delivery mode (caesarian section or vaginal)	Day 0
The presentation in childbirth	Day 0

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France