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Completed

NCT Number: NCT02801201

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

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.

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Key information

Conditions

Breech Presentation Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Bupivacaine

Drug

Primary outcomes

  1. Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation

    Time frame: 24 hours

Secondary outcomes

  1. occurrence of side events due to the manipulation itself

    Time frame: Day 0

    cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes

  2. occurrence of side events due to anesthesia

    Time frame: 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).

  3. The pain experienced by the patient: assessed by the Visual Analogic Scale

    Time frame: Day 0

  4. The final delivery mode (caesarian section or vaginal)

    Time frame: Day 0

  5. The presentation in childbirth

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: RaVem

Important dates

Study start
2016
Primary completion
2024
Study completion
2025
First posted
Jun 15, 2016
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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