Pregnant WomanASSISTNCT04169035
The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
A study testing The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers. and forceps or ventouse in people with Pregnant Woman, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Woman
- What is being tested?
- The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers. and forceps or ventouse
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2019to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The woman is ≥18 years of age
- The woman has a singleton pregnancy
- The pregnancy is ≥28+0 weeks' gestation
- There is a negative antenatal screen for HIV and Hepatitis B
Who cannot join
- The woman does not fulfil all of the inclusion criteria listed
- There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)
- There is a known osteogenesis imperfecta affected pregnancy
- There is suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia)
- There is an intrauterine fetal death in the current pregnancy
- The woman is sensitive to latex
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- The woman is currently serving a prison sentence
- The woman lacks capacity to consent
- The woman has a lack of ability to read or understand French as this would preclude successful completion of questionnaires
- The woman has received intramuscular or intravenous opiates (i.e. pethidine or morphine) within the past 6 hours
- The woman is in established labour (≥ 4cm cervical dilatation) without regional analgesia in place
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Besancon
Besançon
Louis BENAZET
Nicolas Mottet
About this study
Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.
- Conditions
- Pregnant Woman
- Being tested
- The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers., forceps or ventouse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.Device
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.
forceps or ventouseProcedure or surgery
The woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth.
Forceps is a metal instrument with two handles used to encircle a baby's head and assist in birth.
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 |
|---|---|---|
| Odon device | Experimental | The practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assiste vaginal birth. Odon trained practitioner available to assist the birth. Receives: Device: The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers. |
| Forceps or ventouse | Active comparator | The practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assisted vaginal birth.
The woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth. Receives: Procedure: forceps or ventouse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of births successfully assisted with the BD Odon Device
Successful vaginal birth with the BD ODON DeviceTM: successful BD Odon assisted birth in the absence of maternal and neonatal serious adverse reactions
Measured: 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start4 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomanStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169035
- Sponsor's protocol ID
- P/2019/435
- Acronym
- ASSIST
- Status last verified
- Mar 2021
- First submitted
- 14 Nov 2019
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mottet N, Hotton E, Eckman-Lacroix A, Bourtembourg A, Metz JP, Cot S, Poitrey E, Delhomme L, Languerrand E, Nallet C, Lallemant M, Draycott T, Riethmuller D. Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study. Am J Obstet Gynecol. 2024 Mar;230(3S):S947-S958. doi: 10.1016/j.ajog.2023.05.016. Epub 2023 Aug 1.
PubMed 38462265
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
- ClinicalTrials.gov ID
- NCT04169035
- Acronym / sponsor ID
- ASSIST / P/2019/435
- Conditions
- Pregnant Woman
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Odon device | Experimental | Device: The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.The practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assiste vaginal birth. Odon trained practitioner available to assist the birth. |
| Forceps or ventouse | Active comparator | Procedure: forceps or ventouseThe practitioner providing the woman's care in labour determines that she requires an assisted vaginal birth, and there is no obstetric indication for an alternative method of assisted vaginal birth. The woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The woman is ≥18 years of age
- The woman has a singleton pregnancy
- The pregnancy is ≥28+0 weeks' gestation
- There is a negative antenatal screen for HIV and Hepatitis B
Key exclusion criteria (11 listed)
- The woman does not fulfil all of the inclusion criteria listed
- There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)
- There is a known osteogenesis imperfecta affected pregnancy
- There is suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia)
- There is an intrauterine fetal death in the current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.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 | Odon device |
| forceps or ventouseThe woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth. Forceps is a metal instrument with two handles used to encircle a baby's head and assist in birth. 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. | Procedure or surgery | Forceps or ventouse |
Primary outcome
Rate of births successfully assisted with the BD Odon Device
Time frame: 3 months after delivery
Successful vaginal birth with the BD ODON DeviceTM: successful BD Odon assisted birth in the absence of maternal and neonatal serious adverse reactions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 38462265Mottet N, Hotton E, Eckman-Lacroix A, Bourtembourg A, Metz JP, Cot S, Poitrey E, Delhomme L, Languerrand E, Nallet C, Lallemant M, Draycott T, Riethmuller D. Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study. Am J Obstet Gynecol. 2024 Mar;230(3S):S947-S958. doi: 10.1016/j.ajog.2023.05.016. Epub 2023 Aug 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers. and forceps or ventouse in people with Pregnant Woman, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis BENAZET (+33 381 219 147, lbenazet@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of births successfully assisted with the BD Odon Device (time frame: 3 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.