Impact of Simulation Training for Obstetrics-gynecology Residents.

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Impact of Simulation Training on the Success Rate of External Cephalic Version and Vacuum Assisted Delivery in Clinical Practice. A Randomized Controlled Trial.

Conditions
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Simulation Training

Intervention / Treatment
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* Other: Simulation training for ECV
* Other: Simulation training for VE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For the intervention (trained) group, training sessions will be conducted over six months. The control group will learn obstetric maneuver during daily clinical practice in the delivery room under supervision (usual resident training without simulation sessions). The groups will cross-over for the next 6 months. After six months the success rate and secondary outcomes will be analyzed. The comparison will be, first, between the intervention (trained) group and the control group and, second, for each subject, between its success rate reported before and its success rate after the observation period. Some aspects of our study design can be those of a cross over trial, or a stepped wedge design : the participants will have intervention ECV followed, after 6 months, by intervention VE, or intervention VE followed, after 6 months, by intervention ECV. However as some aspects are not those of the above designs, the investigators believe that the best category is a parallel trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simulation training for ECV<br>For the intervention (trained) group, the training sessions will be conducted over six months. During this period participants will continue their daily clinical practice in the delivery room: when one of these maneuvers is needed, a case report form (CRF) will be completed by the participant. This group is the Control group for VE : The control group will learn obstetric maneuver during daily clinical practice in the delivery room under supervision (usual resident training without simulation sessions). When one of these maneuvers is needed, a case report form (CRF) will be completed by the participant. | Other: Simulation training for ECV<br>* Intervention for the ECV group is a ECV simulation training. The group will have theoretical courses and five simulation sessions with four ECV simulation on a model (i.e., a total of 20 ECV), associated with clinical practice in the delivery room.<br>|
| Experimental: Simulation training for VE<br>For the intervention (trained) group, the training sessions will be conducted over six months. During this period participants will continue their daily clinical practice in the delivery room: when one of these maneuvers is needed, a case report form (CRF) will be completed by the participant. This group is the the control group for for ECV : The control group will learn obstetric maneuver during daily clinical practice in the delivery room under supervision (usual resident training without simulation sessions). When one of these maneuvers is needed, a case report form (CRF) will be completed by the participant. | Other: Simulation training for VE<br>* Intervention for the VE group is a simulation training. The group will have theoretical courses and five simulation sessions with four VE simulation on a model (i.e., a total of 20 VE), associated with clinical practice in the delivery room. The investigators will us Kiwi® Omni Cup Vacuum Delivery System, as this is the vacuum system chosen for clinical practice in our obstetric service.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the ECV in the participant clinical practice | 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 | 6 months | 
| Success rate of the VE in the participant clinical practice | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for stopping ECV | That is : success, patient request, transmission to supervisor, maximum number of trials reached | 6 months | 
| Maximum pain during ECV on numeric rating scale | Maximum pain during the procedure, reported by the women, using a the numeric rating scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain) | 6 months | 
| Maternal satisfaction after the ECV on numeric rating scale | Global satisfaction reported by the women 2 hours after the ECV using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied) | 6 months | 
| Participant satisfaction after the ECV on numeric rating scale | Global satisfaction reported by the participant after the ECV using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied) | 6 months | 
| Rate of complication (ECV) | That is : bleeding, suspicious or pathological cardiotocography (see appendix 1), Kleihauer> 1, retro-placental hematoma, reported in the hour following the ECV | 6 months | 
| Rate of emergency cesarean section (ECV) | Rate of emergency cesarean section performed in case of ECV complication | 6 months | 
| Reason for stopping VE | That is : success, release, transmission to supervisor | 6 months | 
| Number of pull for VE | Number of pull on the Kiwi® Omni Cup Vacuum Delivery System necessary for birth | 6 months | 
| Maternal satisfaction after the VE on numeric rating scale | Global satisfaction reported by the women 2 hours after the VE using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied) | 6 months | 
| Participant satisfaction after the VE on numeric rating scale | Global satisfaction reported by the participant after the VE using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied) | 6 months | 
| Rate of complication (VE) | That is : subdural hematoma, subgaleal or intracranial hemorrhage, skull fracture, fetal scalp laceration, third- or four-degree perineal tear, vaginal tear) | 6 months | 
| Rate emergency cesarean section rate (VE) | Rate of emergency cesarean section performed and indication | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simulation training, Obstetrics, External cephalic version, Vacuum assisted delivery