Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.

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

pregnant women