Impact of Simulation Training for Obstetrics-gynecology Residents.

Simulation Training Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03848975
• Other study ID #: 2016-00310
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: November 1, 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Geneva
• Contact: Lorraine Grangier, MD
• Phone: +41795535019
• Email: lorraine.grangier[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Simulation Training

Intervention

Other:
• Simulation training for ECV
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.
• Simulation training for VE
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.

Locations

Country	Name	City	State
Switzerland	Gynecology & obstetrics department of Geneva University Hospital (Hôpitaux Universitaires de Genève (HUG)	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (11)

Bogner G, Xu F, Simbrunner C, Bacherer A, Reisenberger K. Single-institute experience, management, success rate, and outcome after external cephalic version at term. Int J Gynaecol Obstet. 2012 Feb;116(2):134-7. doi: 10.1016/j.ijgo.2011.09.027. Epub 2011 Dec 9. — View Citation

Collaris RJ, Oei SG. External cephalic version: a safe procedure? A systematic review of version-related risks. Acta Obstet Gynecol Scand. 2004 Jun;83(6):511-8. Review. — View Citation

Crofts JF, Bartlett C, Ellis D, Hunt LP, Fox R, Draycott TJ. Training for shoulder dystocia: a trial of simulation using low-fidelity and high-fidelity mannequins. Obstet Gynecol. 2006 Dec;108(6):1477-85. — View Citation

Deering S, Poggi S, Macedonia C, Gherman R, Satin AJ. Improving resident competency in the management of shoulder dystocia with simulation training. Obstet Gynecol. 2004 Jun;103(6):1224-8. — View Citation

Draycott T, Sibanda T, Owen L, Akande V, Winter C, Reading S, Whitelaw A. Does training in obstetric emergencies improve neonatal outcome? BJOG. 2006 Feb;113(2):177-82. — View Citation

Fransen AF, van de Ven J, Merién AE, de Wit-Zuurendonk LD, Houterman S, Mol BW, Oei SG. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial. BJOG. 2012 Oct;119(11):1387-93. doi: 10.1111/j.1471-0528.2012.03436.x. Epub 2012 Aug 13. — View Citation

Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83. — View Citation

Hickok DE, Gordon DC, Milberg JA, Williams MA, Daling JR. The frequency of breech presentation by gestational age at birth: a large population-based study. Am J Obstet Gynecol. 1992 Mar;166(3):851-2. — View Citation

Jastrow N, Picchiottino P, Savoldelli G, Irion O. [Simulation in obstetrics]. Rev Med Suisse. 2013 Oct 23;9(403):1938-40, 1942. French. — View Citation

Pichon M, Guittier MJ, Irion O, Boulvain M. [External cephalic version in case of persisting breech presentation at term: motivations and women's experience of the intervention]. Gynecol Obstet Fertil. 2013 Jul-Aug;41(7-8):427-32. doi: 10.1016/j.gyobfe.2012.09.029. Epub 2012 Oct 25. French. — View Citation

Teoh TG. Effect of learning curve on the outcome of external cephalic version. Singapore Med J. 1997 Aug;38(8):323-5. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cup position (VE)	The investigators will document with a picture of the newborn's skull the area where the cup was placed to determine if the placement of the cup was correct. The photos will then be reviewed by the investigator and the position will be judged correct or incorrect. The correct positioning rate will be calculated	6 months
Primary	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
Primary	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	Reason for stopping ECV	That is : success, patient request, transmission to supervisor, maximum number of trials reached	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of emergency cesarean section (ECV)	Rate of emergency cesarean section performed in case of ECV complication	6 months
Secondary	Reason for stopping VE	That is : success, release, transmission to supervisor	6 months
Secondary	Number of pull for VE	Number of pull on the Kiwi® Omni Cup Vacuum Delivery System necessary for birth	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate emergency cesarean section rate (VE)	Rate of emergency cesarean section performed and indication	6 months