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TerminatedNCT04260386Updated Aug 6, 2021

Assessing a New Proforma for Maternal Cardiac Arrest

An observational study in Maternal Death, Cardiac Arrest and Heart Arrest, sponsored by Chelsea and Westminster NHS Foundation Trust. Terminated at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational

Why this study was terminated
The study closed early due to COVID-19
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
39
Sex
All
01

Study summary

During the Multidisciplinary Obstetric and Midwifery Simulation (MOMS) course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link.

The delegates observing the cardiac arrest scenario will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. Delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma.

Read the detailed description

The use of standardised proformas can improve the quality and completeness of data collection in healthcare settings. In a previous study we have found that medical records examined by the Confidential Enquiries into Maternal Deaths (CEMD) 2009-2012 were variable in their quality, often poor and in need of improvement. In view of this, we have developed a proforma to assist the quality of record-keeping during maternal cardiac arrest, using a modified Delphi process amongst a multidisciplinary group of CEMD assessors. The present application is for a study evaluating clinicians' views of this proforma and its usefulness in a simulator setting (as maternal cardiac arrest is so rare, evaluation in actual cases would be a very lengthy and expensive venture; such a study would have to be multicentre and would require a preliminary evaluation such as the one being proposed here, anyway).

One hundred participants will take part in the study during the routine Multidisciplinary Obstetric and Midwifery Simulation (MOMS) training course at the Chelsea and Westminster Hospital. During the course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link. A brief information sheet and explanation will be provided before consent is sought to take part in the study.

During the cardiac arrest scenario, the delegates observing will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. One or more team members would routinely be given the role of 'scribe', recording events as they occur. Delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma. All of the data will be collected pseudo-anonymously.

02

Conditions studied

  • Maternal Death
  • Cardiac Arrest
  • Heart Arrest

Keywords

  • Maternal Cardiac Arrest
  • Clinical Scenarios Simulation
03

In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's enrollment of 39 is below the median of 180 across 19 observational studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

One hundred participants will take part in the study during the routine Multidisciplinary Obstetric and Midwifery Simulation (MOMS) training course at the Chelsea and Westminster Hospital. During the course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Delegates taking part in the routine Multidisciplinary Obstetric and Midwifery Simulation training course at the Chelsea and Westminster Hospital.

Exclusion criteria

Exclusion Criteria:

  • Unwillingness to participate and provide written consent.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
39 participants (actual)
Patient registry
No

Groups and cohorts

  • Staff receiving the MOMS training

    Delegates taking part in the routine Multidisciplinary Obstetric and Midwifery Simulation (MOMS) training course at the Chelsea and Westminster Hospital.

    Other: Non-Interventional

Interventions

  • OtherNon-Interventional

    During the cardiac arrest scenario, the delegates observing will be asked to refer to the maternal cardiac arrest proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. One or more team members would routinely be given the role of 'scribe', recording events as they occur. The proforma is accompanied by explanatory notes on how to use it. Delegates (observers plus scribes) will then be asked to complete a questionnaire, seeking their opinions on the usefulness of the proforma. Questionnaires will be linked to the written consent forms by a participant ID number.

06

What researchers measure

Primary outcomes

  1. Views of the multidisciplinary team members on the utility of the proforma in simulated clinical scenarios of maternal cardiac arrest.

    The primary outcome is the views of multidisciplinary team members on the usefulness of the maternal cardiac arrest proforma. Researchers will not be assessing the completion of the proforma so they will not be collecting these at the end of the simulation. They have chosen to test the proforma during simulated maternal cardiac arrest, as the best practicable surrogate for an actual maternal cardiac arrest.

    Time frame: Each participant is expected to be in the study for one day.

07

Study locations

1 site
  • Chelsea and Westminster Hospital
    London, Greater London SW10 9NH, United Kingdom
08

References and documents

Publications

  • Patel A, Rockall A, Guthrie A, Gleeson F, Worthy S, Grubnic S, Burling D, Allen C, Padhani A, Carey B, Cavanagh P, Peake MD, Brown G. Can the completeness of radiological cancer staging reports be improved using proforma reporting? A prospective multicentre non-blinded interventional study across 21 centres in the UK. BMJ Open. 2018 Oct 2;8(10):e018499. doi: 10.1136/bmjopen-2017-018499. PubMed 30282676 ↗
  • Green AR, Hoyle J, Knight MK, Yentis SM. Documentation of maternal cardiac arrest in clinical case notes. International Journal of Obstetric Anesthesia 2017; 31 Suppl 1: S41.
  • A proforma for recording maternal cardiac arrest, R Soysa, MK Knight, SM Yentis. International Journal of Obstetric Anesthesia 2019 (in press).

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04260386
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Responsible party
Sponsor
First posted
Feb 7, 2020
Start date
Aug 23, 2019
Primary completion
Mar 11, 2020
Completion
Mar 11, 2020
Last update
Aug 6, 2021

Study contacts

Eleanor Roderick, BMBCh BA
principal investigator · Chelsea and Westminster NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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