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CompletedNCT03453879TeamOBSUpdated Mar 5, 2018

Observation of Emergency Obstetrical Situations.

An observational study in Unspecified Obstetrical Trauma, With Delivery and Emergencies, sponsored by TeamOBS. Completed at 2 sites in Denmark. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by TeamOBS · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
235
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Unspecified Obstetrical Trauma, With Delivery
  • Emergencies

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants in the study will include working staff (junior and senior doctors, midwifes and other health personal) in the maternity wards of two hospitals in Central Region Denmark: Horsens Regional Hospital and Aarhus University Hospital, Skejby. Video recording in simulation as well in reality will take place in both hospitals. Approximately 200 different teams each of 3-5 persons will participate in the study. In the live emergency scenarios

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

Exclusion Criteria:

Absent informed consent.

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
235 participants (actual)
Patient registry
No

Groups and cohorts

  • 1: Study population

    Participants in this study are working staff (junior and senior doctors, midwifes and other health personal) in the maternity wards of two hospitals in Central Region Denmark: Horsens Regional Hospital and Aarhus University Hospital, Skejby.

    Other: no intervention

Interventions

  • Otherno intervention

    No intervention - only observation of teams delivering acute obstetric care

05

What researchers measure

Primary outcomes

  1. Clinical performance

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

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

Secondary outcomes

  1. Blood loss

    Blood loss measured and verbalized by the emergency team.

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

06

Study locations

2 sites
  • Aarhus University hospital Skejby
    Aarhus, DK 8200, Denmark
  • Horsens Hospital
    Horsens, DK 8700, Denmark
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03453879
Lead sponsor
TeamOBS
Collaborators
Aarhus University Hospital Skejby, Horsens Hospital
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Oct 15, 2014
Primary completion
May 20, 2017
Completion
Feb 1, 2018
Last update
Mar 5, 2018

Study contacts

Niels Uldbjerg, MD.PHD
study chair · University of Aarhus
Ole Kierkegaard, MD
principal investigator · Horsens Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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