Impact of Simulation Training for Obstetrics-gynecology Residents.
- Conditions
- Simulation Training
- Interventions
- Other: Simulation training for ECVOther: Simulation training for VE
- Registration Number
- NCT03848975
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 68
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simulation training for ECV Simulation training for ECV 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. Simulation training for VE Simulation training for VE 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.
- Primary Outcome Measures
Name Time Method Success rate of the ECV in the participant clinical practice 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 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
- Secondary Outcome Measures
Name Time Method Participant satisfaction after the ECV on numeric rating scale 6 months 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)
Rate of complication (ECV) 6 months That is : bleeding, suspicious or pathological cardiotocography (see appendix 1), Kleihauer\> 1, retro-placental hematoma, reported in the hour following the ECV
Rate of emergency cesarean section (ECV) 6 months Rate of emergency cesarean section performed in case of ECV complication
Reason for stopping VE 6 months That is : success, release, transmission to supervisor
Number of pull for VE 6 months Number of pull on the Kiwi® Omni Cup Vacuum Delivery System necessary for birth
Maternal satisfaction after the VE on numeric rating scale 6 months 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)
Participant satisfaction after the VE on numeric rating scale 6 months 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)
Rate of complication (VE) 6 months That is : subdural hematoma, subgaleal or intracranial hemorrhage, skull fracture, fetal scalp laceration, third- or four-degree perineal tear, vaginal tear)
Rate emergency cesarean section rate (VE) 6 months Rate of emergency cesarean section performed and indication
Reason for stopping ECV 6 months That is : success, patient request, transmission to supervisor, maximum number of trials reached
Maximum pain during ECV on numeric rating scale 6 months 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)
Maternal satisfaction after the ECV on numeric rating scale 6 months 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)
Trial Locations
- Locations (1)
Gynecology & obstetrics department of Geneva University Hospital (Hôpitaux Universitaires de Genève (HUG)
🇨🇭Geneva, Switzerland