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Simulation TrainingNCT03848975

Impact of Simulation Training for Obstetrics-gynecology Residents.

A study testing Simulation training for ECV and Simulation training for VE in people with Simulation Training, run by University Hospital, Geneva at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Simulation Training
What is being tested?
Simulation training for ECV and Simulation training for VE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteSwitzerland
Study dates
28 Aug 2018to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Lorraine Grangier, MD contact

+41795535019

lorraine.grangier@hcuge.ch

Bénédicte LeTinier, MD contact

+41795530127

Benedictine.leTinier@hcuge.ch

Switzerland1 site, 1 recruiting

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

    Geneva, 1211

    Lorraine Grangier, MD, +417895535019, lorraine.grangier@hcuge.ch

    Bénédicte LeTinier, MD, +41795530127, Benedictine.leTinier@hcuge.ch

    Recruiting

Other trials in Switzerland

About this study

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.

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.

Read the 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).

Being tested
Simulation training for ECV, Simulation training for VE
Keywords
Simulation training, Obstetrics, External cephalic version, Vacuum assisted delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulation training for ECVOther

    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 VEOther

    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.

Study groups in NCT03848975
Study groupRoleWhat they receive
Simulation training for ECVExperimentalFor 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.
Receives: Other: Simulation training for ECV
Simulation training for VEExperimentalFor 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.
Receives: Other: Simulation training for VE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

Secondary outcomes (12)

  1. Reason for stopping ECV

    That is : success, patient request, transmission to supervisor, maximum number of trials reached

    Measured: 6 months

  2. 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)

    Measured: 6 months

  3. 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)

    Measured: 6 months

  4. 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)

    Measured: 6 months

  5. 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

    Measured: 6 months

  6. Rate of emergency cesarean section (ECV)

    Rate of emergency cesarean section performed in case of ECV complication

    Measured: 6 months

  7. Reason for stopping VE

    That is : success, release, transmission to supervisor

    Measured: 6 months

  8. Number of pull for VE

    Number of pull on the Kiwi® Omni Cup Vacuum Delivery System necessary for birth

    Measured: 6 months

  9. 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)

    Measured: 6 months

  10. 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)

    Measured: 6 months

  11. 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)

    Measured: 6 months

  12. Rate emergency cesarean section rate (VE)

    Rate of emergency cesarean section performed and indication

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study start28 Aug 2018
  3. Primary completion1 Nov 2022 (estimated)
  4. Study completion1 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03848975
Sponsor's protocol ID
2016-00310
Other IDs
2016
Status last verified
May 2021
First submitted
19 Feb 2019
Last updated
10 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 24245015

  • 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.

    PubMed 22882714

  • 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.

    PubMed 16411995

  • 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.

    PubMed 17138783

  • 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.

    PubMed 15172856

  • 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.

    PubMed 1550152

  • 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.

    PubMed 11052579

  • 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.

    PubMed 15144330

  • 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.

    PubMed 22169098

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

    PubMed 9364883

  • 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.

    PubMed 23102577

Questions about this trial

What is this clinical trial studying?

A study testing Simulation training for ECV and Simulation training for VE in people with Simulation Training, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lorraine Grangier, MD (+41795535019, lorraine.grangier@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of the ECV in the participant clinical practice (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03848975, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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