NCT03453879

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

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

October 15, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
Last Updated

March 5, 2018

Status Verified

February 1, 2018

Enrollment Period

2.6 years

First QC Date

April 12, 2016

Last Update Submit

February 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical performance

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

    15. october 2014 - 20. May 2016

Secondary Outcomes (1)

  • Blood loss

    15. october 2014 - 20. May 2016

Study Arms (1)

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

No intervention - only observation of teams delivering acute obstetric care

1: Study population

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Absent informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University hospital Skejby

Aarhus, DK, 8200, Denmark

Location

Horsens Hospital

Horsens, DK, 8700, Denmark

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Niels Uldbjerg, MD.PHD

    University of Aarhus

    STUDY CHAIR
  • Ole Kierkegaard, MD

    Horsens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

March 5, 2018

Study Start

October 15, 2014

Primary Completion

May 20, 2017

Study Completion

February 1, 2018

Last Updated

March 5, 2018

Record last verified: 2018-02

Locations