ISRCTN10203171已完成未知
The BD Odon Device for assisted vaginal birth: a safety and feasibility study
orth Bristol NHS Trust0 个研究点目标入组 97 人开始时间: 2018年7月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 97
研究概览
简要总结
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30836979/ protocol (added 26/10/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33316274/ (added 27/07/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34911726/ qualitative study of participant experiences (added 17/12/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35926994/ integrated qualitative case study methodology (added 05/08/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Women will be eligible to participate in the study if ALL of the following apply:
- •1. The woman is =18 years of age
- •2. The woman has a singleton pregnancy
- •3. The pregnancy is =36+0 weeks’ gestation
- •4. The woman may require an AVB for a clinical indication – see below
- •Presumed fetal compromise
- •1. Maternal fatigue/exhaustion
- •2. Lack of continuing progress of the fetal head following the time limits of active second stage recommended by the National Institute of Health and Care Excellence (NICE) (2 hours for a woman in her first pregnancy with no analgesia, 1 hour for a woman in her first pregnancy with analgesia who has already been in the second stage of labour for 2 hours, 1 hour for women in a 2nd or greater pregnancy)
- •3. To shorten and reduce the effects of the second stage of labour on medical conditions (i.e. cardiac disease, myasthenia gravis, hypertensive crises, proliferative retinopathy, spinal cord injury patients at risk of autonomic dysreflexia, etc)
- •*Adapted from the Royal College of Obstetricians & Gynaecologists 2011
- •4. 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)
- •5. 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 ventouse)
- •Babies will be included if their mother is participating in the study
排除标准
- •Women may not enter the study, or will be removed from the study, if any of the following apply:
- •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. Fetal bradycardia
研究者
相似试验
已完成
2 期
The BD Odon Device™ for assisted vaginal birthAssisted vaginal birthPregnancy and ChildbirthISRCTN38829082orth Bristol NHS Trust126
Unknown
不适用
The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and EfficacyPregnant WomanNCT04169035Centre Hospitalier Universitaire de Besancon104
已完成
不适用
The Simulation Training for Operative vaginal Birth – Evaluation (STROBE) studySpecialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ MidwiferyUKCRC code/ Disease: Reproductive Health and Childbirth/ DeliveryPregnancy and ChildbirthISRCTN11760611orth Bristol NHS Trust2,400
终止
不适用
Feasibility and safety of a new device (Odon device) for assisted vaginal deliveriesProlonged second stage of labourReproductive Health and Childbirth - Fetal medicine and complications of pregnancyACTRN12613000141741World Health Organization130
已完成
不适用
Umbilical Vein Needle Catheterization for Endotracheal Intubation.Infant Respiratory Distress SyndromeNCT03359993Hôpital NOVO5