---
title: Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management
nct_id: NCT01618565
overall_status: COMPLETED
phase: PHASE3
sponsor: Clemens Tempfer
study_type: INTERVENTIONAL
primary_condition: Shoulder Dystocia
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01618565.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01618565"
ct_last_update_post_date: 2022-07-08
last_seen_at: "2026-05-12T07:18:22.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management

**Official Title:** Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial

**NCT ID:** [NCT01618565](https://clinicaltrials.gov/study/NCT01618565)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 203
- **Lead Sponsor:** Clemens Tempfer
- **Conditions:** Shoulder Dystocia
- **Start Date:** 2012-04
- **Completion Date:** 2012-12
- **CT.gov Last Update:** 2022-07-08

## Brief 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* informed consent

Exclusion Criteria:

* none
```

## Arms

- **Hands-On Training** (EXPERIMENTAL) — 30 minutes hands-on training of maneuvers to manage shoulder dystocia
- **Demonstration** (ACTIVE_COMPARATOR) — 30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia

## Interventions

- **Hands-On Training** (PROCEDURE) — one-time, 30 minute hands-on training
- **Demonstration** (PROCEDURE) — 30 minutes passive training

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Performance Time** _(time frame: 30 minutes)_
- **Global Rating Scale** _(time frame: 30 minutes)_

## Locations (2)

- Dept. OBGYN Ruhr University Bochum, Herne, Germany
- Dept. OBGYN, Ruhr University Bochum, Herne, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.dept. obgyn ruhr university bochum|herne||germany` — added _(2026-05-12)_
- `locations.dept. obgyn, ruhr university bochum|herne||germany` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01618565*  
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