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NCT03453879 Clinical Trial

Observation of Emergency Obstetrical Situations.

Emergencies Clinical Trial

— TeamOBS  

Official title:
TeamOBS - Focuses on the Association Between Teamwork and Clinical Performance in Emergency Obstetrical Situations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03453879
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received April 12, 2016
Last updated February 26, 2018
Start date October 15, 2014
Est. completion date February 1, 2018

Study information
Verified date February 2018
Source TeamOBS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The TeamOBS study is an observational study. We analyze actually recordings of obstetric emergencies to get an even better understanding and knowledge of the association between the communication and cooperation and the quality of the performance of the interdisciplinary team.

Description:

Background:

In obstetric emergency situations (OES) inadequate non-technical skills (NTS) are the leading causes of substandard care.

Aim:

Based on live audio and video (AV)-recordings of real (OES) the aim is to describes how the NTS and the clinical performance are related.

Method:

1. Inclusion of the teams. OES teams from the delivery ward at two Danish hospitals, Aarhus University Hospital and Horsens Regional Hospital are AV-recorded are collected and saved for analyzing with consent from all participant.

2. Develop a scoring tool to rate clinical performance in OES. 12 Ekspert Senior Obstetricians from different maternity units in Britain, Norway, Sweden, Denmark and Iceland volunteered to join the Delphi panel and develop a clinical performance tool.

3. Rate clinical performance. Using the developed tool in 2) to rate live teams

4. Rate NTS Recording of teams will be rated by the validated list: Assessment of Obstetric Team Performance with the validated tool from Pamela Morgan: AOTP. Furthermore important observations will be code. Video assessments is planned for 2016-2018

5. Explore the association between clinical performance and NTS in OES. Results from 3) and 4) will be compared.

Discussion:

We expect that this study will add to the knowledge of NTS and the effect on clinical performance in OES.

Recruitment information / eligibility
Status Completed
Enrollment 235
Est. completion date February 1, 2018
Est. primary completion date May 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Video recordings of emergency situations in simulation aswell live will include management of every day situations as well as rare emergencies, with the inclusion criteria of obstetric teamwork: >2 healthcare personal present and one of them an obstetrician. The five situations in are study are the following:

1. Eclampsia,

2. Post-partum haemorrhage,

3. New -born resuscitation (Apgar = 7/5 min),

4. Shoulder dystocia and

5. Instrumental delivery. The situation can be included if a video recording is capture of the event and all participant in the video have given informed consent.

Exclusion Criteria:

Absent informed consent.

Study Design

Related Conditions & MeSH terms

  • Emergencies
  • Unspecified Obstetrical Trauma, With Delivery

Intervention

Other:
• no intervention
No intervention - only observation of teams delivering acute obstetric care

Locations
Country Name City State
Denmark Aarhus University hospital Skejby Aarhus DK
Denmark Horsens Hospital Horsens DK

Sponsors (3)
Lead Sponsor Collaborator
TeamOBS Aarhus University Hospital Skejby, Horsens Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical performance Clinical performance is assessed by video raters, using a checklist TeamOBS-tool 15. october 2014 - 20. May 2016
Secondary Blood loss Blood loss measured and verbalized by the emergency team. 15. october 2014 - 20. May 2016
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