The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy

Not Applicable

• Conditions: Pregnant Woman
• Interventions: Device: The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.; Procedure: forceps or ventouse

• Registration Number: NCT04169035
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Study Start: 2019-12-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-05
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Odon 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	forceps or ventouse	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.

Primary Outcome Measures

Name	Time	Method
Rate of births successfully assisted with the BD Odon Device	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

Trial Locations

Locations (1)

Chu Besancon; 🇫🇷 Besançon, France