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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04646486
Other study ID # TEAMOBS Intervention
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2020
Est. completion date December 31, 2022

Study information

Verified date September 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Women with major postpartum hemorrhage (1.0 liter or more). Exclusion Criteria: - Language difficulties requiring an interpreter or translator

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video debriefing
Obstetric teams will review their own performance on video in a debriefing session to improve future performance.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus N
Denmark Horsens Regional Hospital Horsens

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Horsens Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Brogaard 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. d — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) All videos will be assessed 2.5 years (autumn 2023)
Secondary Non-technical performance Videos will be assessed by raters using the AOTP checklist. All videos will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. Time of day. - Day/Night Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. Blood loss. - Total blood loss (ml) Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. GA. - Gestational age Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. Birth length (>18 hours). - Yes/No Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. Epidural - Yes/No Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. Oxytocin. - Yes/No Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. Induction. - Yes/No Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal birth characteristics. Twin pregnancy. - Yes/No Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal characteristics additional. Age. - Years Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal characteristics additional. BMI. - BMI Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal characteristics additional. Previous postpartum hemorrhage. - Yes/No Data will be assessed 2.5 years (autumn 2023)
Secondary Maternal characteristics additional. Previous births - Number Data will be assessed 2.5 years (autumn 2023)
Secondary Team characteristics. Team size. - Number of team members involved Data will be assessed 2.5 years (autumn 2023)
Secondary Team characteristics. Hospital. - Regional / University Data will be assessed 2.5 years (autumn 2023)
Secondary Neonatal characteristics. Mean birth weight. - Grams Data will be assessed 2.5 years (autumn 2023)
Secondary Implementation of video debriefing Number of debriefing sessions performed (in total / per participant / failed attempted sessions). Data will be assessed 2.5 years (autumn 2023)
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