Impact of Simulation Training for Obstetrics-gynecology Residents.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Simulation Training

Clinical Trial Details

NCT number	NCT03848975
Study type	Interventional
Source	University Hospital, Geneva
Contact	Lorraine Grangier, MD
Phone	+41795535019
Email	lorraine.grangier@hcuge.ch
Status	Recruiting
Phase	N/A
Start date	August 28, 2018
Completion date	November 1, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.