This is a pivotal study designed to demonstrate the non-inferiority of the Odon Device™ versus vacuum extraction
Woman aged over 18 years
Woman who has signed the informed consent form
The woman has a singleton pregnancy
The pregnancy is ≥37+0 weeks' gestation
Major congenital malformations diagnosed prenatally in the neonate
Contraindications to instrumental vaginal delivery
Intrauterine fetal death
Maternal latex allergy
Parallel
Experimental: The BD Odon DeviceTM
DeviceThe 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
DeviceVentouse 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.
Demonstrate the non-inferiority of the ODON™ device compared with the obstetric vacuum extractor in assisted vaginal delivery.
Proportion of patients with a successful outcome in each randomized arm. Success will be defined as the successful completion of vaginal delivery using the assigned instrument. Failure will be defined as the need for a cesarean section or the sequential use of another type of instrument to complete the vaginal delivery.
Evaluate the neonatal and maternal safety of instrumental delivery
1. Neonatal safety: composite of adverse neonatal outcomes Number of participants whose neonate presents at least one of the following: death, umbilical arterial pH \< 7.2 ; Apgar score \< 7 at 5 minutes; admission to the Neonatal Intensive Care Unit; soft-tissue injury (bruising, caput succedaneum, cephalohematoma, subgaleal hemorrhage, laceration); jaundice requiring phototherapy. Time frame: \[From birth to day 28\] 2. Maternal safety : composite of adverse maternal outcomes Number of participants with at least one of the following: death, obstetric anal sphincter injury (perineal tear grade 3A, 3B, 3C or fourth-degree); cervical tear requiring suturing; estimated total blood loss ≥ 500 mL. Time frame: \[From delivery to day 28\]
To assess the proportion of neonates with superficial soft tissue injuries
To assess obstetrician satisfaction
The obstetrician will evaluate their satisfaction with the device by completing a paper assessment form satisfaction scale between 1 to 4, 1 for the best outcome ( 14 questions )
To assess maternal satisfaction
QEVA/Childbirth Experience Questionnaire (QACE) : paper assessment form scale between 1 to 4, (the best outcome is 1 for some questions, and 4 for other) The questionnaire includes a total of 26 questions. QEVA/QACE : before hospital discharge ; at day 28 (mail); at day 90 (mail); at 1 year (mail)
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