Postpartum HemorrhageNCT04646486
Video Debriefing at the Delivery Ward
A study testing Video debriefing in people with Postpartum Hemorrhage, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality worldwide. Successful management of postpartum hemorrhage requires not only administration of the right medicine, but also a rapid and coordinated response from a multi-professional team. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Video debriefing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Women with major postpartum hemorrhage (1.0 liter or more).
Who cannot join
- Language difficulties requiring an interpreter or translator
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus N, 8200
Horsens Regional Hospital
Horsens, 8700
About this study
Official title: Video Debriefing at the Delivery Ward - Empowering Obstetric Teams to High Performance
Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality worldwide. Successful management of postpartum hemorrhage requires not only administration of the right medicine, but also a rapid and coordinated response from a multi-professional team. A prerequisite for this is that the individuals are well trained, which the investigators believe can be improved by video debriefing of real-life events.
The purpose of this study is to improve obstetric teams management of postpartum hemorrhage using video recordings of real-life events in post event debriefings.
Cameras are placed in the ceiling of all delivery rooms to record obstetric teams' management of postpartum hemorrhage. Video recording requires informed consent from all participants. After an event, the team will review their own performance on video in a debriefing session to improve future performance.
Read the detailed description
Background:
Video review was first introduced in healthcare in the 1980s to improve emergency teams' management of critical situations by having them review their own performance on video in a debriefing session. Video debriefing offers an opportunity to review the care delivered in high-stake, high-risk, and time-critical situations. Video debriefing has been found to improve the performance of neonatal resuscitation teams and trauma teams; however, video debriefing has not generally been accepted in the delivery ward. A recent PhD project developed a method for systematically filming obstetric emergencies, in two Danish hospitals, where informed consent had been obtained from all participants. In addition, the project developed a method for systematically assessing obstetric teams' clinical performance during postpartum hemorrhage
The aim of the study is to examine the effect of real-life video debriefing on obstetric teams' management of major postpartum hemorrhage.
Material and methods:
The study will be conducted at two Danish hospitals, Aarhus University Hospital (5,000 deliveries per year) and Horsens Regional Hospital (2,300 deliveries per year).
All delivery rooms have been equipped with an automatic recording system that enables filming of all postpartum hemorrhage. Video recording requires informed consent from all participants. Women expecting to deliver will be invited to provide informed consent for video recording. If a woman declines the invitation, the cameras will be covered up according to our protocol. If video recording occurs, all participants will be asked to give informed consent again.
Video debriefing will be conducted by educated facilitators of debriefing. Debriefings will follow a protocol and will focus on teams' clinical performance and non-technical skills. The main focus of the debriefing protocol will be clinical debriefing with a main goal of improving clinical performance and patient care.
Videos will be included as follows: 1) Baseline video inclusion, before introducing real-life video debriefings of team performance; 2) During the start-up of the debriefings in an exploratory study; 3) After real-life video debriefings have been introduced as standard procedure.
Perspectives:
This project is the first to evaluate the implementation, feasibility and use of real-life video debriefing in obstetric care. Results from this project can revolutionize the ability to learn from clinical cases and can guide how video can be introduced in ways acceptable to women, relatives and healthcare providers.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Video debriefing
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video debriefingBehavioural
Obstetric teams will review their own performance on video in a debriefing session to improve future performance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Video debriefing | Experimental | Baseline period (year 1): Standard practice. Intervention period (year 2-3): All teams will be assigned to video debriefing. Receives: Behavioral: Video debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Videos will be assessed by raters using the TeamOBS-PPH checklist (Brogaard L et al, Development of the TeamOBS-PPH - targeting clinical performance in postpartum hemorrhage, 2018)
Measured: All videos will be assessed 2.5 years (autumn 2023)
Secondary outcomes (17)
Non-technical performance
Videos will be assessed by raters using the AOTP checklist.
Measured: All videos will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Time of day.
- Day/Night
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Blood loss.
- Total blood loss (ml)
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. GA.
- Gestational age
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Birth length (>18 hours).
- Yes/No
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Epidural
- Yes/No
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Oxytocin.
- Yes/No
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Induction.
- Yes/No
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Twin pregnancy.
- Yes/No
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. Age.
- Years
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. BMI.
- BMI
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. Previous postpartum hemorrhage.
- Yes/No
Measured: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. Previous births
- Number
Measured: Data will be assessed 2.5 years (autumn 2023)
Team characteristics. Team size.
- Number of team members involved
Measured: Data will be assessed 2.5 years (autumn 2023)
Team characteristics. Hospital.
- Regional / University
Measured: Data will be assessed 2.5 years (autumn 2023)
Neonatal characteristics. Mean birth weight.
- Grams
Measured: Data will be assessed 2.5 years (autumn 2023)
Implementation of video debriefing
Number of debriefing sessions performed (in total / per participant / failed attempted sessions).
Measured: Data will be assessed 2.5 years (autumn 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start11 Nov 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Data - videos of team performance - will be included as follows: Year 1) Baseline. Video inclusion, before introducing real-life video debriefings of team performance (n=200). Year 2) During the start-up of the debriefings (n=20) which will be evaluated in a feasibility study. Year 2-3) Intervention. After real-life video debriefings have been introduced as standard procedure (n=200).
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Horsens Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646486
- Sponsor's protocol ID
- TEAMOBS Intervention
- Status last verified
- Sep 2022
- First submitted
- 12 Nov 2020
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will be publicly available in an anonymized form using an open data repository.
Publications
Brogaard L, Kierkegaard O, Hvidman L, Jensen KR, Musaeus P, Uldbjerg N, Manser T. The importance of non-technical performance for teams managing postpartum haemorrhage: video review of 99 obstetric teams. BJOG. 2019 Jul;126(8):1015-1023. doi: 10.1111/1471-0528.15655. Epub 2019 Mar 27.
PubMed 30771263Brogaard L, Hvidman L, Hinshaw K, Kierkegaard O, Manser T, Musaeus P, Arafeh J, Daniels KI, Judy AE, Uldbjerg N. Development of the TeamOBS-PPH - targeting clinical performance in postpartum hemorrhage. Acta Obstet Gynecol Scand. 2018 Jun;97(6):677-687. doi: 10.1111/aogs.13336. Epub 2018 Apr 2.
PubMed 29485679
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Debriefing at the Delivery Ward - Empowering Obstetric Teams to High Performance
- ClinicalTrials.gov ID
- NCT04646486
- Acronym / sponsor ID
- TEAMOBS Intervention
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Horsens Hospital
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Nov 2020 (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.
Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality worldwide. Successful management of postpartum hemorrhage requires not only administration of the right medicine, but also a rapid and coordinated response from a multi-professional team. A prerequisite for this is that the individuals are well trained, which the investigators believe can be improved by video debriefing of real-life events.
The purpose of this study is to improve obstetric teams management of postpartum hemorrhage using video recordings of real-life events in post event debriefings.
Cameras are placed in the ceiling of all delivery rooms to record obstetric teams' management of postpartum hemorrhage. Video recording requires informed consent from all participants. After an event, the team will review their own performance on video in a debriefing session to improve future performance.
Detailed description
Background:
Video review was first introduced in healthcare in the 1980s to improve emergency teams' management of critical situations by having them review their own performance on video in a debriefing session. Video debriefing offers an opportunity to review the care delivered in high-stake, high-risk, and time-critical situations. Video debriefing has been found to improve the performance of neonatal resuscitation teams and trauma teams; however, video debriefing has not generally been accepted in the delivery ward. A recent PhD project developed a method for systematically filming obstetric emergencies, in two Danish hospitals, where informed consent had been obtained from all participants. In addition, the project developed a method for systematically assessing obstetric teams' clinical performance during postpartum hemorrhage
The aim of the study is to examine the effect of real-life video debriefing on obstetric teams' management of major postpartum hemorrhage.
Material and methods:
The study will be conducted at two Danish hospitals, Aarhus University Hospital (5,000 deliveries per year) and Horsens Regional Hospital (2,300 deliveries per year).
All delivery rooms have been equipped with an automatic recording system that enables filming of all postpartum hemorrhage. Video recording requires informed consent from all participants. Women expecting to deliver will be invited to provide informed consent for video recording. If a woman declines the invitation, the cameras will be covered up according to our protocol. If video recording occurs, all participants will be asked to give informed consent again.
Video debriefing will be conducted by educated facilitators of debriefing. Debriefings will follow a protocol and will focus on teams' clinical performance and non-technical skills. The main focus of the debriefing protocol will be clinical debriefing with a main goal of improving clinical performance and patient care.
Videos will be included as follows: 1) Baseline video inclusion, before introducing real-life video debriefings of team performance; 2) During the start-up of the debriefings in an exploratory study; 3) After real-life video debriefings have been introduced as standard procedure.
Perspectives:
This project is the first to evaluate the implementation, feasibility and use of real-life video debriefing in obstetric care. Results from this project can revolutionize the ability to learn from clinical cases and can guide how video can be introduced in ways acceptable to women, relatives and healthcare providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Data - videos of team performance - will be included as follows: Year 1) Baseline. Video inclusion, before introducing real-life video debriefings of team performance (n=200). Year 2) During the start-up of the debriefings (n=20) which will be evaluated in a feasibility study. Year 2-3) Intervention. After real-life video debriefings have been introduced as standard procedure (n=200).
| Arm | Type | Receives |
|---|---|---|
| Intervention - Video debriefing | Experimental | Behavioral: Video debriefingBaseline period (year 1): Standard practice. Intervention period (year 2-3): All teams will be assigned to video debriefing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women with major postpartum hemorrhage (1.0 liter or more).
Key exclusion criteria (1 listed)
- Language difficulties requiring an interpreter or translator
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 |
|---|---|---|
| Video debriefingObstetric teams will review their own performance on video in a debriefing session to improve future performance. | Behavioural | Intervention - Video debriefing |
Primary outcome
Clinical performance
Time frame: All videos will be assessed 2.5 years (autumn 2023)
Videos will be assessed by raters using the TeamOBS-PPH checklist (Brogaard L et al, Development of the TeamOBS-PPH - targeting clinical performance in postpartum hemorrhage, 2018)
17 secondary outcomes
Non-technical performance
Time frame: All videos will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Time of day.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Blood loss.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. GA.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Birth length (>18 hours).
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Epidural
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Oxytocin.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Induction.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal birth characteristics. Twin pregnancy.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. Age.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. BMI.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. Previous postpartum hemorrhage.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Maternal characteristics additional. Previous births
Time frame: Data will be assessed 2.5 years (autumn 2023)
Team characteristics. Team size.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Team characteristics. Hospital.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Neonatal characteristics. Mean birth weight.
Time frame: Data will be assessed 2.5 years (autumn 2023)
Implementation of video debriefing
Time frame: Data will be assessed 2.5 years (autumn 2023)
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 11 May 2023.
- Results publication: PubMed 30771263Brogaard L, Kierkegaard O, Hvidman L, Jensen KR, Musaeus P, Uldbjerg N, Manser T. The importance of non-technical performance for teams managing postpartum haemorrhage: video review of 99 obstetric teams. BJOG. 2019 Jul;126(8):1015-1023. doi: 10.1111/1471-0528.15655. Epub 2019 Mar 27.
- Results publication: PubMed 29485679Brogaard L, Hvidman L, Hinshaw K, Kierkegaard O, Manser T, Musaeus P, Arafeh J, Daniels KI, Judy AE, Uldbjerg N. Development of the TeamOBS-PPH - targeting clinical performance in postpartum hemorrhage. Acta Obstet Gynecol Scand. 2018 Jun;97(6):677-687. doi: 10.1111/aogs.13336. Epub 2018 Apr 2.
- Individual participant dataSharing planned: Yes. The final dataset will be publicly available in an anonymized form using an open data repository.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video debriefing in people with Postpartum Hemorrhage, run by University of Aarhus 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 1 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 11 May 2023. 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: All videos will be assessed 2.5 years (autumn 2023)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646486, which also lists 2 linked publications.
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 11 May 2023.