Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries

Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Training VAD
• Intervention / Treatment: Other: theory-based training programme; Other: practice-based training programme (one-to-one teaching)

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Dept. Obstetrics and Gynaecology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no oral and written informed consent

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
Other: theory-based training programme; theory-based training programme (oral presentation including a step-by-step guidance saying)	Other: theory-based training programme; theory-based training programme for conducting VAD
Other: practice-based training; practice-based training programme (one-to-one teaching)	Other: practice-based training programme (one-to-one teaching); practice-based training programme (one-to-one teaching) for conducting VAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical skills in conducting VAD	General and procedure-specific skills will be assessed using a validated rating tool.	one day (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of skills conducting VAD	General and procedure-specific skills will be assessed using a validated rating tool.	4-8 weeks after day 0
trainees' satisfaction	trainees' satisfaction with the two different training programmes will be assessed using a questionnaire	4-8 weeks after day 0

Collaborators and Investigators

• Sponsor: Heinrich Husslein
• Investigators: Study Chair: Julian Marschalek, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): February 13, 2020

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: training; Vacuum assisted delivery; technical skills
• Other Study ID Numbers: 2300/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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