NCT04646486

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

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

November 11, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 11, 2023

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

November 12, 2020

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Non-technical performance

    All videos will be assessed 2.5 years (autumn 2023)

  • Maternal birth characteristics. Time of day.

    Data will be assessed 2.5 years (autumn 2023)

  • Maternal birth characteristics. Blood loss.

    Data will be assessed 2.5 years (autumn 2023)

  • Maternal birth characteristics. GA.

    Data will be assessed 2.5 years (autumn 2023)

  • Maternal birth characteristics. Birth length (>18 hours).

    Data will be assessed 2.5 years (autumn 2023)

  • +12 more secondary outcomes

Study Arms (1)

Intervention - Video debriefing

EXPERIMENTAL

Baseline period (year 1): Standard practice. Intervention period (year 2-3): All teams will be assigned to video debriefing.

Behavioral: Video debriefing

Interventions

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

Intervention - Video debriefing

Eligibility Criteria

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

You may qualify if:

  • Women with major postpartum hemorrhage (1.0 liter or more).

You may not qualify if:

  • Language difficulties requiring an interpreter or translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Related Publications (2)

  • 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.

  • 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. doi: 10.1111/aogs.13336. Epub 2018 Apr 2.

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Videos from baseline period and intervention period will be mixed and assessed at the end of the study. The raters will be blinded to which period the video originates from
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 30, 2020

Study Start

November 11, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 11, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

The final dataset will be publicly available in an anonymized form using an open data repository.

Time Frame
Study protocol is available at the projects homepage www.teamobs.dk. Trial related documents and data will be available when results are published and until three years after publication of the last study results.
Access Criteria
Interested parties will be able to request the data by contacting the trial sponsor.

Locations