Clinical trial NCT03848975: Impact of Simulation Training for Obstetrics-gynecology Residents.
Official title: Impact of Simulation Training on the Success Rate of External Cephalic Version and Vacuum Assisted Delivery in Clinical Practice. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simulation Training
Keywords: Simulation training
Obstetrics
External cephalic version
Vacuum assisted delivery
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of the ECV in the participant clinical practice
timeFrame: 6 months
measure: Success rate of the VE in the participant clinical practice
timeFrame: 6 months
Secondary outcomes:
measure: Reason for stopping ECV
timeFrame: 6 months
measure: Maximum pain during ECV on numeric rating scale
timeFrame: 6 months
measure: Maternal satisfaction after the ECV on numeric rating scale
timeFrame: 6 months
measure: Participant satisfaction after the ECV on numeric rating scale
timeFrame: 6 months
measure: Rate of complication (ECV)
timeFrame: 6 months
measure: Rate of emergency cesarean section (ECV)
timeFrame: 6 months
measure: Reason for stopping VE
timeFrame: 6 months
measure: Number of pull for VE
timeFrame: 6 months
measure: Maternal satisfaction after the VE on numeric rating scale
timeFrame: 6 months
measure: Participant satisfaction after the VE on numeric rating scale
timeFrame: 6 months
measure: Rate of complication (VE)
timeFrame: 6 months
measure: Rate emergency cesarean section rate (VE)
timeFrame: 6 months
Other outcomes:
measure: Cup position (VE)
timeFrame: 6 months
Locations:
city: Geneva
country: Switzerland
facility: Gynecology & obstetrics department of Geneva University Hospital (Hôpitaux Universitaires de Genève (HUG)
Study officials:
References:
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