The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Rate of births successfully assisted with the BD Odon Device
研究概览
简要总结
Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Odon device
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.
干预措施: The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers. (Device)
Forceps or ventouse
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.
干预措施: forceps or ventouse (Procedure)
结局指标
主要结局
Rate of births successfully assisted with the BD Odon Device
时间窗: 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
次要结局
未报告次要终点