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

Breech Presentation Clinical Trial

— RaVem  

Official title:

Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801201
• Other study ID #: PI2016_843_0001
• Status: Recruiting
• Phase: Phase 3
• Start date: May 31, 2016
• Est. completion date: November 30, 2019

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Julien CHEVREAU, MD
• Phone: +33 3 22 08 74 52
• Email: chevreau.julien[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breech Presentation

Intervention

Drug:
• Midazolam

• Bupivacaine

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation		24 hours
Secondary	occurrence of side events due to the manipulation itself	cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes	Day 0
Secondary	occurrence of side events due to anesthesia	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).	Day 0
Secondary	The pain experienced by the patient: assessed by the Visual Analogic Scale		Day 0
Secondary	The final delivery mode (caesarian section or vaginal)		Day 0
Secondary	The presentation in childbirth		Day 0