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

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

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

Conditions
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Pregnant Woman

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Odon device<br>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. | Device: The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.<br>* 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.<br>|
| Active Comparator: Forceps or ventouse<br>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. | Procedure: forceps or ventouse<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of births successfully assisted with the BD Odon Device | Successful vaginal birth with the BD ODON DeviceTM: successful BD Odon assisted birth in the absence of maternal and neonatal serious adverse reactions | 3 months after delivery |