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

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