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Observation of Emergency Obstetrical Situations. (TeamOBS)

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ClinicalTrials.gov Identifier: NCT03453879
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
Aarhus University Hospital Skejby
Horsens Hospital
Information provided by (Responsible Party):
TeamOBS

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Unspecified Obstetrical Trauma, With Delivery Emergencies Other: no intervention

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.

Study Design
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Study Type : Observational
Actual Enrollment : 235 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: TeamOBS - Focuses on the Association Between Teamwork and Clinical Performance in Emergency Obstetrical Situations
Actual Study Start Date : October 15, 2014
Actual Primary Completion Date : May 20, 2017
Actual Study Completion Date : February 1, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
No intervention - only observation of teams delivering acute obstetric care


Outcome Measures
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Primary Outcome Measures :
  1. Clinical performance [ Time Frame: 15. october 2014 - 20. May 2016 ]
    Clinical performance is assessed by video raters, using a checklist TeamOBS-tool


Secondary Outcome Measures :
  1. Blood loss [ Time Frame: 15. october 2014 - 20. May 2016 ]
    Blood loss measured and verbalized by the emergency team.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453879


Locations
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Denmark
Aarhus University hospital Skejby
Aarhus, DK, Denmark, 8200
Horsens Hospital
Horsens, DK, Denmark, 8700
Sponsors and Collaborators
TeamOBS
Aarhus University Hospital Skejby
Horsens Hospital
Investigators
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Study Chair: Niels Uldbjerg, MD.PHD University of Aarhus
Principal Investigator: Ole Kierkegaard, MD Horsens Hospital
More Information
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Responsible Party: TeamOBS
ClinicalTrials.gov Identifier: NCT03453879    
Other Study ID Numbers: 1
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes