Impact of Simulation Training for Obstetrics-gynecology Residents.

Impact of Simulation Training on the Success Rate of External Cephalic Version and Vacuum Assisted Delivery in Clinical Practice. A Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Simulation Training
• Intervention / Treatment: Other: Simulation training for ECV; Other: Simulation training for 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).

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorraine Grangier, MD; Phone Number: +41795535019; Email: lorraine.grangier@hcuge.ch
• Study Contact Backup: Name: Bénédicte LeTinier, MD; Phone Number: +41795530127; Email: Benedictine.leTinier@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Gynecology & obstetrics department of Geneva University Hospital (Hôpitaux Universitaires de Genève (HUG)
    • Contact: Bénédicte LeTinier, MD; Phone Number: +41795530127; Email: Benedictine.leTinier@hcuge.ch
    • Contact: Lorraine Grangier, MD; Phone Number: +417895535019; Email: lorraine.grangier@hcuge.ch
    • Principal Investigator: Nicole Jastrow-Meyer, MD,PD
    • Sub-Investigator: Lorraine Grangier, MD
    • Sub-Investigator: Bénédicte LeTinier, MD
    • Sub-Investigator: Michel Boulvain, Prof
    • Sub-Investigator: Véronique Othenin-Girard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reason for stopping ECV	That is : success, patient request, transmission to supervisor, maximum number of trials reached	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)	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)	6 months
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
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
Rate of emergency cesarean section (ECV)	Rate of emergency cesarean section performed in case of ECV complication	6 months
Reason for stopping VE	That is : success, release, transmission to supervisor	6 months
Number of pull for VE	Number of pull on the Kiwi® Omni Cup Vacuum Delivery System necessary for birth	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)	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)	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)	6 months
Rate emergency cesarean section rate (VE)	Rate of emergency cesarean section performed and indication	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Publications and helpful links

General Publications

• Jastrow N, Picchiottino P, Savoldelli G, Irion O. [Simulation in obstetrics]. Rev Med Suisse. 2013 Oct 23;9(403):1938-40, 1942. French.
• Fransen AF, van de Ven J, Merien 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.
• 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. doi: 10.1111/j.1471-0528.2006.00800.x.
• 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. doi: 10.1097/01.AOG.0000246801.45977.c8.
• 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. doi: 10.1097/01.AOG.0000126816.98387.1c.
• 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. doi: 10.1016/0002-9378(92)91347-d.
• 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. doi: 10.1016/s0140-6736(00)02840-3.
• 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. doi: 10.1111/j.0001-6349.2004.00347.x.
• 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.
• Teoh TG. Effect of learning curve on the outcome of external cephalic version. Singapore Med J. 1997 Aug;38(8):323-5.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Obstetrics; External cephalic version; Simulation training; Vacuum assisted delivery
• Other Study ID Numbers: 2016-00310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No