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Completed

NCT Number: NCT03453879

Observation of Emergency Obstetrical Situations.

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University hospital Skejby, Aarhus, DK, Denmark

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About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • Eclampsia,
  • Post-partum haemorrhage,
  • New -born resuscitation (Apgar ≤ 7/5 min),
  • Shoulder dystocia and
  • 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.

Treatment and study plan

No intervention

Other

No intervention - only observation of teams delivering acute obstetric care

Primary outcomes

  1. Clinical performance

    Time frame: 15. october 2014 - 20. May 2016

    Clinical performance is assessed by video raters, using a checklist TeamOBS-tool

Secondary outcomes

  1. Blood loss

    Time frame: 15. october 2014 - 20. May 2016

    Blood loss measured and verbalized by the emergency team.

Sponsors and collaborators

Lead sponsor

TeamOBS

Other

Collaborators

  • Aarhus University Hospital Skejby
  • Horsens Hospital

Registry information

Official study title

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

Acronym: TeamOBS

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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