Pregnant WomenE-SAFE-ODONNCT07862842
Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction
A study testing Experimental: The BD Odon DeviceTM and Active Comparator: Vacuum extraction group in people with Pregnant Women, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
This is a pivotal study designed to demonstrate the non-inferiority of the Odon Device™ versus vacuum extraction Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Experimental: The BD Odon DeviceTM and Active Comparator: Vacuum extraction group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Live fetus
- Fetus in cephalic presentation
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- Woman with complete cervical dilatation
- Clinical indication for instrumental vaginal delivery
- Engaged cephalic presentation
- Ultrasound assessment prior to instrument application (Suprapubic confirmation of the fetal head position (occiput position) and Transperineal ultrasound measurement of the head-perineum distance, without probe pressure, ≤ 45 mm)
Who cannot join
- Major congenital malformations diagnosed prenatally in the neonate
- Contraindications to instrumental vaginal delivery
- Intrauterine fetal death
- Maternal latex allergy
- Legal incapacity or limited legal capacity
- Subject considered unlikely to comply with study procedures and/or anticipated by the investigator to have poor compliance
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- Woman unable to provide informed consent
- Woman unable to read or understand French
- Subject without health insurance coverage
- Subject currently within the exclusion period of another clinical study or listed in the French National Volunteer Registry ("Fichier National des Volontaires")
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: E-SAFE-ODON : Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction: A Multicenter Randomized Pivotal Trial
This is a pivotal study designed to demonstrate the non-inferiority of the Odon Device™ versus vacuum extraction
Read the detailed description
The Odon Device™ is a novel instrument designed to assist vaginal delivery during the second stage of labor. This pivotal multicenter randomized controlled trial aims to demonstrate the non-inferiority of the Odon Device™ compared with vacuum extraction for operative vaginal delivery.
The study will evaluate the performance and safety of the Odon Device™ in women requiring operative vaginal delivery. Maternal and neonatal outcomes will be compared between the Odon Device™ and vacuum extraction groups.
- Conditions
- Pregnant Women
- Being tested
- Experimental: The BD Odon DeviceTM, Active Comparator: Vacuum extraction group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: The BD Odon DeviceTMDevice
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 groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| The BD Odon DeviceTM | Experimental | Not described Receives: Device: Experimental: The BD Odon DeviceTM |
| Vacuum extraction group | Active comparator | Not described Receives: Device: Active Comparator: Vacuum extraction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
Evaluate the neonatal and maternal safety of instrumental delivery
- 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]
- 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]
Measured: 28 days
To assess the proportion of neonates with superficial soft tissue injuries
Measured: 28 days
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 )
Measured: 1 day
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)
Measured: 1 year
To assess urinary and anal continence
Female Pelvic Floor Questionnaire (FPFQ)
The patient will complete the questionnaire prior to hospital discharge and at 28 days (mail), 90 days (mail) , and 1 year postpartum (mail).
FPFQ is between 0 to 3, for some questions 0 is the best outcome, for other 3 is the best outcome.
The questionnaire includes a total of 37 questions.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille NALLET, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862842
- Sponsor's protocol ID
- 2026/1034
- Acronym
- E-SAFE-ODON
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No