NCT03111498

Brief Summary

Training is very important for acquisition and maintenance of obstetric skills. As a one-to-one practical teaching needs time and personal resources, the investigators want to prove the benefit and necessity of the one-to-one training program compared to a theory-based training program in conducting vacuum assisted deliveries (VAD). The aim of this study is to prove that a practice-based training program (one-to- one teaching) leads to better training results compared to a theory-based training program in conducting VAD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2.9 years

First QC Date

March 15, 2017

Last Update Submit

February 22, 2021

Conditions

Keywords

Vacuum assisted deliverytechnical skillstraining

Outcome Measures

Primary Outcomes (1)

  • technical skills in conducting VAD

    General and procedure-specific skills will be assessed using a validated rating tool.

    one day (day 0)

Secondary Outcomes (2)

  • Retention of skills conducting VAD

    4-8 weeks after day 0

  • trainees' satisfaction

    4-8 weeks after day 0

Study Arms (2)

theory-based training programme

OTHER

theory-based training programme (oral presentation including a step-by-step guidance saying)

Other: theory-based training programme

practice-based training

OTHER

practice-based training programme (one-to-one teaching)

Other: practice-based training programme (one-to-one teaching)

Interventions

practice-based training programme (one-to-one teaching) for conducting VAD

practice-based training

theory-based training programme for conducting VAD

theory-based training programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • employees of the Department of Obstetrics and Gynaecology
  • oral and written informed consent

You may not qualify if:

  • no oral and written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Obstetrics and Gynaecology, Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

  • Julian Marschalek, MD

    Medical University of Vienna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: video-recorded vacuum procedure on a special VAD-training phantom in a randomized setting: (1) theory-based training programme (2) practice-based training programme (one-to-one teaching). Video-recorded vacuum procedure on the VAD- training phantom before randomization, directly after training programme, 4-8 weeks after training programme in order to determine retention of skills.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass-Prof., MD

Study Record Dates

First Submitted

March 15, 2017

First Posted

April 12, 2017

Study Start

March 9, 2017

Primary Completion

February 13, 2020

Study Completion

February 13, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations