Impact of Simulation Training on the Success Rate of External Cephalic Version and Vacuum Assisted Delivery in Clinical Practice. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Success rate of the ECV in the participant clinical practice
研究概览
简要总结
The main objective of the study is to evaluate the benefit of simulator training for learning external cephalic version (ECV) or vacuum assisted vaginal delivery (hereafter vacuum extraction [VE]) for obstetrics-gynecology residents.
The primary outcome of this randomized control trial is to evaluate the impact of simulation training on the success of ECV and VE.
详细描述
Usually, the training of obstetrical maneuvers are done "one the job" according to the situations encountered in the clinical practice during postgraduate training. This has some disadvantages like inequality of exposure to these situations, inadequate learning environment (emergencies, impossibility to repeat the maneuver, etc.) and risk complications related to the learner'slack of experience. To evaluate the benefit for learning external cephalic version (ECV) or vacuum assisted vaginal delivery (hereafter vacuum extraction [VE]), the investigators are conducting a randomized control trial composed by two parallel studies. Each group will represent the control group in relation to the maneuver to which it will not be trained.
The objectives of the first one is to evaluate the impact of simulation training on the success of ECV, the complication rate, as well as the patient's and learner's satisfaction. The objectives of the second one is to evaluate the impact of simulation training on the success of VE, the complication rate, as well as the patient's and learner's satisfaction.
The overall goal is to evaluate the effects on clinically relevant outcomes of the teaching by simulation in obstetrics. If simulation training improves the success rate of these maneuvers and the satisfaction of the patient and the learner, simulation learning will be included in a formal and systematic way during postgraduate training in obstetrics.
The subjects are the resident doctors or consultants who have had no or few prior simulation training (maximum 1 session) and little clinical experience of the maneuver evaluated (maximum of 19 of each maneuver).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
The person who generate the randomization list and prepare the envelopes will not be involved later in the study. The subject of this study necessarily involves the fact that the participants know the group to which they are assigned. They will be asked to avoid to reveal their allocation to the other care providers (midwives and other colleagues) involved in the care of the patients delivering under their supervision. The investigator responsible for collecting and coding the data will not know to which group belongs the person being evaluated. In some cases, the midwife in charge of the patient will collect the data. She will not know to which group belongs to the person being evaluated. The patient will not know to which group belongs the doctor practicing the obstetric maneuver. However the study taking place within a hospital, it can not be excluded that a care provider or an outcome assessor learns informally the allocation of one or more participants, despite these precautions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being a resident or consultant working in the gynecology and obstetrics department of the hospital
- •Agreeing to participate in the study by signing an informed consent form
排除标准
- •Having performed several ECV or VE simulation training (more than 1 session each) before the recruitment
- •Having already performed more than 20 ECV and more than 20 VE during clinical practice before recruitment.
- •Having a planned clinical activity in the delivery room which does not allow to perform at least 1 ECV or 1 VE during the study period.
结局指标
主要结局
Success rate of the ECV in the participant clinical practice
时间窗: 6 months
The success of the procedure is defined as the passage of the fetus from a breech ou transverse presentation to a cephalic presentation, immediately confirmed by ultrasound, after a maximum of 2 trials. The outcomes for each procedure (success or not) will be judged at the end of the procedure
Success rate of the VE in the participant clinical practice
时间窗: 6 months
The success rate of the procedure is defined as birth after vacuum-assisted delivery without release of the Kiwi cup. The cup's release is considered when total and involuntary loss of vacuum occurs, resulting in a loss of contact with the head. If the patient gives birth spontaneously after a vacuum release or if there is a change of instrumentation (following a release or not), it is a failure in the context of this study. The outcomes for each procedure (success or not) will be judge at the end of the procedure
次要结局
- Participant satisfaction after the ECV on numeric rating scale(6 months)
- Rate of complication (ECV)(6 months)
- Rate of emergency cesarean section (ECV)(6 months)
- Reason for stopping VE(6 months)
- Number of pull for VE(6 months)
- Maternal satisfaction after the VE on numeric rating scale(6 months)
- Participant satisfaction after the VE on numeric rating scale(6 months)
- Rate of complication (VE)(6 months)
- Rate emergency cesarean section rate (VE)(6 months)
- Reason for stopping ECV(6 months)
- Maximum pain during ECV on numeric rating scale(6 months)
- Maternal satisfaction after the ECV on numeric rating scale(6 months)
研究者
Nicole Jastrow Meyer
Principal investigator
University Hospital, Geneva