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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
68
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.
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.
Gynecology & obstetrics department of Geneva University Hospital (Hôpitaux Universitaires de Genève (HUG)
Geneva, Switzerland
RECRUITINGSuccess 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
Time frame: 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
Time frame: 6 months
Reason for stopping ECV
That is : success, patient request, transmission to supervisor, maximum number of trials reached
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Participant satisfaction after the ECV on numeric rating scale
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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)
Time frame: 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
Time frame: 6 months
Rate of emergency cesarean section (ECV)
Rate of emergency cesarean section performed in case of ECV complication
Time frame: 6 months
Reason for stopping VE
That is : success, release, transmission to supervisor
Time frame: 6 months
Number of pull for VE
Number of pull on the Kiwi® Omni Cup Vacuum Delivery System necessary for birth
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Rate emergency cesarean section rate (VE)
Rate of emergency cesarean section performed and indication
Time frame: 6 months