Impact of Simulation Training for Obstetrics-gynecology Residents.

NCT03848975 | Unknown

• 1 other identifier: 2016-00310
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Simulation Training

Keywords

Simulation training; Obstetrics; External cephalic version; Vacuum assisted delivery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Reason for stopping ECV

  6 months

• Maximum pain during ECV on numeric rating scale

  6 months

• Maternal satisfaction after the ECV on numeric rating scale

  6 months

• Participant satisfaction after the ECV on numeric rating scale

  6 months

• Rate of complication (ECV)

  6 months

Other Outcomes (1)

• Cup position (VE)

  6 months

Study Arms (2)

Simulation training for ECV

EXPERIMENTAL

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

Simulation training for VE

EXPERIMENTAL

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

Interventions

Simulation training for ECV OTHER

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 ECV

Simulation training for VE OTHER

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.

Simulation training for VE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Gynecology & obstetrics department of Geneva University Hospital (Hôpitaux Universitaires de Genève (HUG)

Geneva, 1211, Switzerland

RECRUITING

Related Publications (11)

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

  PMID: 24245015 BACKGROUND

• 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.

  PMID: 22882714 BACKGROUND

• 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.

  PMID: 16411995 BACKGROUND

• 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.

  PMID: 17138783 BACKGROUND

• 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.

  PMID: 15172856 BACKGROUND

• 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.

  PMID: 1550152 BACKGROUND

• 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.

  PMID: 11052579 BACKGROUND

• 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.

  PMID: 15144330 BACKGROUND

• 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.

  PMID: 22169098 BACKGROUND

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

  PMID: 9364883 BACKGROUND

• 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.

  PMID: 23102577 BACKGROUND

Central Study Contacts

Lorraine Grangier, MD

CONTACT

+41795535019; lorraine.grangier@hcuge.ch

Bénédicte LeTinier, MD

CONTACT

+41795530127; Benedictine.leTinier@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The person who generate the randomization list and prepare the envelopes will not be involved later in the study. The subject of this study necessarily involves the fact that the participants know the group to which they are assigned. They will be asked to avoid to reveal their allocation to the other care providers (midwives and other colleagues) involved in the care of the patients delivering under their supervision. The investigator responsible for collecting and coding the data will not know to which group belongs the person being evaluated. In some cases, the midwife in charge of the patient will collect the data. She will not know to which group belongs to the person being evaluated. The patient will not know to which group belongs the doctor practicing the obstetric maneuver. However the study taking place within a hospital, it can not be excluded that a care provider or an outcome assessor learns informally the allocation of one or more participants, despite these precautions.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: August 28, 2018
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)