NCT01618565

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

June 11, 2012

Last Update Submit

July 7, 2022

Conditions

Shoulder Dystocia

Keywords

shoulder dystociatrainingTo assess the effectiveness of hands-on training versus expert demonstration

Outcome Measures

Primary Outcomes (1)

  • OSATS Score

    Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.

    30 minutes

Secondary Outcomes (2)

  • Performance Time

    30 minutes

  • Global Rating Scale

    30 minutes

Study Arms (2)

Hands-On Training

EXPERIMENTAL

30 minutes hands-on training of maneuvers to manage shoulder dystocia

Procedure: Hands-On Training

Demonstration

ACTIVE COMPARATOR

30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia

Procedure: Demonstration

Interventions

Hands-On TrainingPROCEDURE

one-time, 30 minute hands-on training

Hands-On Training
DemonstrationPROCEDURE

30 minutes passive training

Demonstration

Eligibility Criteria

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

You may qualify if:

  • informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. OBGYN Ruhr University Bochum

Herne, 44625, Germany

Location

Dept. OBGYN, Ruhr University Bochum

Herne, 44625, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22996098RESULT

MeSH Terms

Conditions

Shoulder Dystocia

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department head ObGyn

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

DE(2)