Unspecified Obstetrical Trauma, With DeliveryTeamOBSNCT03453879
Observation of Emergency Obstetrical Situations.
An observational study of Unspecified Obstetrical Trauma, With Delivery and Emergencies, run by TeamOBS at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Unspecified Obstetrical Trauma, With Delivery, Emergencies
- How many people
- 235 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Oct 2014to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Absent informed consent.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University hospital Skejby
Aarhus, DK, 8200
Horsens Hospital
Horsens, DK, 8700
About this study
Official title: TeamOBS - Focuses on the Association Between Teamwork and Clinical Performance in 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.
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:
- 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.
- Being tested
- no intervention
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention - only observation of teams delivering acute obstetric care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Clinical performance is assessed by video raters, using a checklist TeamOBS-tool
Measured: 15. october 2014 - 20. May 2016
Secondary outcomes (1)
Blood loss
Blood loss measured and verbalized by the emergency team.
Measured: 15. october 2014 - 20. May 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start15 Oct 2014
- Primary completion20 May 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Obstetrical Trauma, With DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- TeamOBS
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Horsens Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Uldbjerg, MD.PHD, Study chair, University of AarhusOle Kierkegaard, MD, Principal investigator, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453879
- Sponsor's protocol ID
- 1
- Acronym
- TeamOBS
- Status last verified
- Feb 2018
- First submitted
- 12 Apr 2016
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeamOBS - Focuses on the Association Between Teamwork and Clinical Performance in Emergency Obstetrical Situations
- ClinicalTrials.gov ID
- NCT03453879
- Acronym / sponsor ID
- TeamOBS / 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- TeamOBSUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Horsens Hospital
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: Study population | – | Other: no interventionParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Absent informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNo intervention - only observation of teams delivering acute obstetric care | Other | 1: Study population |
Primary outcome
Clinical performance
Time frame: 15. october 2014 - 20. May 2016
Clinical performance is assessed by video raters, using a checklist TeamOBS-tool
1 secondary outcome
Blood loss
Time frame: 15. october 2014 - 20. May 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Homepage of the the study vist to find full study decription, study protocol, informed consent form, leaflets and news of the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Uldbjerg, MD.PHD study chair
University of Aarhus
Ole Kierkegaard, MD principal investigator
Horsens Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Obstetrical Trauma, With Delivery and Emergencies, run by TeamOBS at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: 15. october 2014 - 20. May 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.