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NOT YET RECRUITING
NCT07862842
NA

Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction

Sponsor: Centre Hospitalier Universitaire de Besancon

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.