Pregnant Woman
Conditions
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.
Interventions
DEVICEThe 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.
PROCEDUREforceps or ventouse
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.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactLouis BENAZET
Outcome results
None listed