Shoulder DystociaPhase 3NCT01618565
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management
A Phase 3 study testing Hands-On Training and Demonstration in people with Shoulder Dystocia, run by Clemens Tempfer at 2 sites in Germany.
Trial summary
This trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia
- What is being tested?
- Hands-On Training and Demonstration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 3
- 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
- informed consent
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dept. OBGYN Ruhr University Bochum
Herne, 44625
Dept. OBGYN, Ruhr University Bochum
Herne, 44625
About this study
Official title: Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial
This trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model.
Read the detailed description
We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized SD algorithm scheme on a pelvic training model. Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.
- Conditions
- Shoulder Dystocia
- Being tested
- Hands-On Training, Demonstration
- Keywords
- shoulder dystocia, training, To assess the effectiveness of hands-on training versus expert demonstration
- Medical subject headings
- Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-On TrainingProcedure or surgery
one-time, 30 minute hands-on training
DemonstrationProcedure or surgery
30 minutes passive training
| Study group | Role | What they receive |
|---|---|---|
| Hands-On Training | Experimental | 30 minutes hands-on training of maneuvers to manage shoulder dystocia Receives: Procedure: Hands-On Training |
| Demonstration | Active comparator | 30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia Receives: Procedure: Demonstration |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSATS Score
Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.
Measured: 30 minutes
Secondary outcomes (2)
Performance Time
Time probands need to perform all test tasks
Measured: 30 minutes
Global Rating Scale
Predefined score including confidence, speed, and manual capacity to perform test tasks
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder DystociaStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemens Tempfer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clemens Tempfer, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618565
- Sponsor's protocol ID
- SD-1
- Status last verified
- Jul 2022
- First submitted
- 11 Jun 2012
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Buerkle B, Pueth J, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial. Obstet Gynecol. 2012 Oct;120(4):809-14. doi: 10.1097/AOG.0b013e31826af9a9.
PubMed 22996098
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01618565
- Acronym / sponsor ID
- SD-1
- Conditions
- Shoulder Dystocia
- Keywords
- shoulder dystocia, training, To assess the effectiveness of hands-on training versus expert demonstration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Clemens TempferUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jun 2012 (estimated)
- 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.
This trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model.
Detailed description
We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized SD algorithm scheme on a pelvic training model. Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hands-On Training | Experimental | Procedure: Hands-On Training30 minutes hands-on training of maneuvers to manage shoulder dystocia |
| Demonstration | Active comparator | Procedure: Demonstration30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Hands-On Trainingone-time, 30 minute hands-on training | Procedure or surgery | Hands-On Training |
| Demonstration30 minutes passive training | Procedure or surgery | Demonstration |
Primary outcome
OSATS Score
Time frame: 30 minutes
Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.
2 secondary outcomes
Performance Time
Time frame: 30 minutes
Global Rating Scale
Time frame: 30 minutes
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 8 Jul 2022.
- Results publication: PubMed 22996098Buerkle B, Pueth J, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial. Obstet Gynecol. 2012 Oct;120(4):809-14. doi: 10.1097/AOG.0b013e31826af9a9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hands-On Training and Demonstration in people with Shoulder Dystocia, run by Clemens Tempfer at 2 sites in Germany.
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 1 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
OSATS Score (time frame: 30 minutes). 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 NCT01618565, which also lists 1 linked publication.
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 8 Jul 2022.