Training VADNCT03111498
Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries
A study testing practice-based training programme (one-to-one teaching) and theory-based training programme in people with Training VAD, run by Heinrich Husslein at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Training VAD
- What is being tested?
- practice-based training programme (one-to-one teaching) and theory-based training programme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustria
- Study dates
- 9 Mar 2017to 13 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- employees of the Department of Obstetrics and Gynaecology
- oral and written informed consent
Who cannot join
- no oral and written informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. Obstetrics and Gynaecology, Medical University of Vienna
Vienna, 1090
About this study
Official title: 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.
- Conditions
- Training VAD
- Being tested
- practice-based training programme (one-to-one teaching), theory-based training programme
- Keywords
- Vacuum assisted delivery, technical skills, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practice-based training programme (one-to-one teaching)Other
practice-based training programme (one-to-one teaching) for conducting VAD
theory-based training programmeOther
theory-based training programme for conducting VAD
| Study group | Role | What they receive |
|---|---|---|
| theory-based training programme | Other | theory-based training programme (oral presentation including a step-by-step guidance saying) Receives: Other: theory-based training programme |
| practice-based training | Other | practice-based training programme (one-to-one teaching) Receives: Other: practice-based training programme (one-to-one teaching) |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical skills in conducting VAD
General and procedure-specific skills will be assessed using a validated rating tool.
Measured: one day (day 0)
Secondary outcomes (2)
Retention of skills conducting VAD
General and procedure-specific skills will be assessed using a validated rating tool.
Measured: 4-8 weeks after day 0
trainees' satisfaction
trainees' satisfaction with the two different training programmes will be assessed using a questionnaire
Measured: 4-8 weeks after day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start9 Mar 2017
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Training VADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich Husslein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heinrich Husslein, Medical University of Vienna
- Investigators
- Julian Marschalek, MD, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111498
- Sponsor's protocol ID
- 2300/2016
- Status last verified
- Feb 2021
- First submitted
- 15 Mar 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03111498
- Acronym / sponsor ID
- 2300/2016
- Conditions
- Training VAD
- Keywords
- Vacuum assisted delivery, technical skills, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Heinrich HussleinUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| theory-based training programme | Other | Other: theory-based training programmetheory-based training programme (oral presentation including a step-by-step guidance saying) |
| practice-based training | Other | Other: practice-based training programme (one-to-one teaching)practice-based training programme (one-to-one teaching) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- employees of the Department of Obstetrics and Gynaecology
- oral and written informed consent
Key exclusion criteria (1 listed)
- no oral and written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| practice-based training programme (one-to-one teaching)practice-based training programme (one-to-one teaching) for conducting VAD | Other | practice-based training |
| theory-based training programmetheory-based training programme for conducting VAD | Other | theory-based training programme |
Primary outcome
technical skills in conducting VAD
Time frame: one day (day 0)
General and procedure-specific skills will be assessed using a validated rating tool.
2 secondary outcomes
Retention of skills conducting VAD
Time frame: 4-8 weeks after day 0
trainees' satisfaction
Time frame: 4-8 weeks after day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Marschalek, MD study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing practice-based training programme (one-to-one teaching) and theory-based training programme in people with Training VAD, run by Heinrich Husslein at 1 site in Austria.
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 1 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: finished, as of the sponsor's last update on 23 Feb 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical skills in conducting VAD (time frame: one day (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.