NCT04050631

Brief Summary

Maternal cardiac arrest is underreported and continues to occur at rate of 1:20,000 pregnancies. Despite being predominantly younger patients, survival rates among pregnant women are poor with one case series reporting a survival rate of 6.9%. Resuscitation of a pregnant women can be challenging when compared to non-pregnant adults. Aggressive maneuvers (perimortum cesarean section) and multidisciplinary team efforts are required because of the anatomical and physiological changes associated with pregnancy, in addition to taking care of two patents (mother and fetus). The first 5 minutes from the onset of cardiac arrest are the most crucial in terms of neonatal survival. In maternal deaths involving acute cardiac arrest, advanced cardiac life support (ACLS) must be rapidly administered. Previous work suggests deficits in cardiac arrest care during maternal cardiac arrest. The current literature fails to adequately quantify the severity, timing and frequency of errors made during maternal cardiac arrest care amongst interprofessional healthcare teams. The primary goal of this study is to characterize the quality of actions by first responders during simulated in-hospital maternal medical emergencies. Specific objectives are:

  1. 1.to examine critical delays by measuring the median duration of the interval between when a resuscitation maneuver was indicated and when it was initiated by first responders ( nursing staff at L\&D attending the patient).
  2. 2.to describe the type and frequency of resuscitation errors identified as deviations from AHA guidelines during obstetric cardiac arrest. By addressing this gap in the literature, we hope to highlight areas of future education and/or innovation aimed at improving performance during maternal cardiac arrest care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 30, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

July 30, 2019

Last Update Submit

March 23, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.

    oxygenation

    10/ minutes

  • The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.

    chest compressions

    100-120/minutes

  • The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.

    defibrillation

    minutes

  • The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.

    time to incision

    5 minutes

Secondary Outcomes (2)

  • Quality of CPR

    15 mins

  • Quality of CPR

    15 minutes

Study Arms (1)

L&D team

the first responders on L\&D floor including : anesthesia, nurses and OBGYN

Behavioral: maternal arrest simulation on L&D floor

Interventions

AFE on L\&D

L&D team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care providers at L\&D floor : Anesthesia, OBGYN, Nurses

You may qualify if:

  • Obstetric healthcare providers: including: nurses, nurse practitioners, respiratory therapists and residents (obstetric and anesthesia)
  • Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) certification within the past two years;

You may not qualify if:

  • Not BLS certified.
  • Participant refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, Canada

RECRUITING

Related Publications (3)

  • Campbell TA, Sanson TG. Cardiac arrest and pregnancy. J Emerg Trauma Shock. 2009 Jan;2(1):34-42. doi: 10.4103/0974-2700.43586.

    PMID: 19561954BACKGROUND
  • Dijkman A, Huisman CM, Smit M, Schutte JM, Zwart JJ, van Roosmalen JJ, Oepkes D. Cardiac arrest in pregnancy: increasing use of perimortem caesarean section due to emergency skills training? BJOG. 2010 Feb;117(3):282-7. doi: 10.1111/j.1471-0528.2009.02461.x.

    PMID: 20078586BACKGROUND
  • Yeomans ER, Gilstrap LC 3rd. Physiologic changes in pregnancy and their impact on critical care. Crit Care Med. 2005 Oct;33(10 Suppl):S256-8. doi: 10.1097/01.ccm.0000183540.69405.90.

    PMID: 16215345BACKGROUND

Study Officials

  • Adam Cheng

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 8, 2019

Study Start

January 5, 2020

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations