ISRCTN38829082已完成2 期
The BD Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy
orth Bristol NHS Trust0 个研究点目标入组 126 人开始时间: 2019年6月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33741082/ (added 22/03/2021) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37322539/ qualitative research undertaken as part of the ASSIST II Trial (added 16/06/2023) 2023 Results article in https://doi.org/10.1016/j.ajog.2023.05.018 (added 23/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Pregnant women aged 18 and over
- •2. In the final stage of labour (full cervical dilatation) who require an AVB. This could be because their labour has slowed down, there are concerns about their baby’s heart rate, or there is a medical reason to shorten the amount of time a woman should push for during labour
- •3. Informed consent has previously been given and has been reconfirmed. All ‘consent’ inclusion have been re-assessed and remain valid.
- •4. Pregnancy is =36+0 weeks’ gestation.
- •5. The woman is in labour and requires an assisted vaginal birth for a clinical indication (as per the Royal College of Obstetricians & Gynaecologists Greentop Guideline, 2011). The RCOG specific requirements for AVB are fulfilled (as per the Royal College of Obstetricians & Gynaecologists Greentop Guideline, 2011). The vertex is 1cm or more below ischial spines.
- •6. The woman has effective analgesia in place during the use of the instrument (i.e. epidural, spinal or pudendal block, or perineal infiltration with local anaesthetic).
- •7. The practitioner providing the woman’s care in labour determines that she requires an AVB, and there is no obstetric indication for an alternative method of AVB (forceps or metal cup). Availability of a suitably trained practitioner.
排除标准
- •Current exclusion criteria as of 10/03/2021:
- •1. The woman does not fulfil all of the inclusion criteria listed
- •2. Maternal-reported fetal skull abnormality, fetal osteogenesis imperfecta or fetal bleeding disorder
- •3. Intrauterine fetal death in the current pregnancy
- •4. The woman is currently serving a prison sentence
- •5. The woman lacks the capacity to consent
- •6. The woman has a lack of ability to read or understand English
- •7. Sensitivity to latex
- •8. Informed consent is withdrawn
- •9. There is an ongoing fetal bradycardia
- •10. Current confirmed or clinically suspected Covid-19 infection
- •11. Woman is shielding from Covid-19 due to a medical condition or medication as per current PHE guidance
- •12. No Odon trained practitioner available to assist the birth
- •Previous exclusion criteria:
- •1. The woman does not fulfil all of the inclusion criteria listed
- •2. There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)
- •3. There is a known osteogenesis imperfecta affected pregnancy
- •4. There is suspicion of a fetal bleeding disorder (von Willebrand’s disease, AITP, haemophilia etc)
- •5. Intrauterine fetal death in the current pregnancy
- •6. The woman is currently serving a prison sentence
- •7. The woman lacks capacity to consent
- •8. The woman has a lack of ability to read or understand English as this would preclude successful completion of questionnaires
- •9. Latex sensitivity
- •10. The indication for AVB is a fetal bradycardia which is present and on-going and has not recovered
- •11. Informed consent is withdrawn at anytime
- •12. Any of the ‘consent’ or ‘participation’ inclusion criteria are not met
- •13. No Odon trained practitioner available to assist the birth
研究者
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