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Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction
Sponsor: Centre Hospitalier Universitaire de Besancon
Summary
This is a pivotal study designed to demonstrate the non-inferiority of the Odon Device™ versus vacuum extraction
Official title: E-SAFE-ODON : Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction: A Multicenter Randomized Pivotal Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
628
Start Date
2026-11
Completion Date
2030-01
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Experimental: The BD Odon DeviceTM
The BD Odon DeviceTM works by placing a cuff of air attached to a plastic sleeve, around the baby's head. The doctor then gently pulls on this sleeve and air cuff to assist the birth of the baby.
Active Comparator: Vacuum extraction group
Ventouse is a device used to help a baby be born by putting it over the baby's head and using suction (= removing air) to pull the baby out of the mother's body.