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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Pregnant Woman

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04169035

P/2019/435

Details and patient eligibility

About

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

Enrollment: 104 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Odon device

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Procedure: forceps or ventouse