Maternal Death During ChildbirthNCT04050631
Critical Delays in Cardiopulmonary Resuscitation During Simulated Obstetric Crisis: a Prospective Observational Study.
An observational study of Maternal Death During Childbirth, run by KidSIM Simulation Program at 1 site in Canada.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Death During Childbirth
- What is being tested?
- maternal arrest simulation on L&D floor
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2020to 30 May 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care providers at L\&D floor : Anesthesia, OBGYN, Nurses
Who may be able to join
- 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;
Who cannot join
- Not BLS certified.
- Participant refusal
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Center
Calgary, Alberta
Fatemah Qasem, MD
About this study
Official title: In Hospital Maternal Cardiac Arrests: Highlighting the Importance of the First 5 Minutes.
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:
- 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).
- 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.
Read the detailed description
The investigators are planning to conduct a pilot descriptive study involving Foothill Medical Centre (FMC), Calgary. Research ethics approval will be obtained. The trial will also be registered at clinicaltrials.gov
The sessions will take place at the labor and delivery floor (L\&D) simulation lab at FMC. The proposed time for study completion is 18 months. No follow up is required for this study. The data will be collected by one of the investigators (Dr. Fatemah Qasem). In addition, the participants performance will be video recorded for further data collection and revision by the investigator team.
On the day of the simulation session, the participants will be pre-briefed to the simulation room, mannequin, and the equipment but will be naïve to the simulation scenario. The simulation scenario will involve amniotic fluid embolism (AFE) in a term pregnant parturient with singleton pregnancy. The patient will have a working epidural catheter in situ for labor analgesia and an 18G IV line. The parturient will develop cardiopulmonary collapse due to AFE requiring ACLS.
The scenario will be scripted by investigator team members. The same scenario will be used at both centers (FMC and RGH). The script will include the initial clinical vignette; vital signs; patient weight; laboratory values; planned changes in clinical status, including what and when decompensations should occur (eg, 4 minutes into scenario, the patient will progress to pulseless VT); and planned responses to actions by participants. Time 0 will be referred to the onset of the decompensation. For maintaining realism, little interaction will occur between participants and evaluators. If no one remembers to call the code team, then the emergency is managed with only L\&D staff. Although the primary focus of this study is to assess the quality of resuscitation delivered by first responders before the code team's arrival, the exercise will also allow to assess the resuscitation skills of obstetric care unit team. The scenario will end at skin incision for delivery of the fetus. Thirty minutes will be used for debriefing time as part of the hospital staff education. Data collected during the debriefing, and discussion points will used for quality improvement purposes and will not be used as part of the study results.
- Conditions
- Maternal Death During Childbirth
- Being tested
- maternal arrest simulation on L&D floor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal arrest simulation on L&D floorBehavioural
AFE on L\&D
| Study group | Role | What they receive |
|---|---|---|
| L&D team | the first responders on L\&D floor including : anesthesia, nurses and OBGYN Receives: Behavioral: maternal arrest simulation on L&D floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 minutes
Secondary outcomes (2)
Quality of CPR
Depth
Measured: 15 mins
Quality of CPR
Rate
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start5 Jan 2020
- Primary completion30 May 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maternal Death During ChildbirthStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KidSIM Simulation Program
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Adam Cheng, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050631
- Sponsor's protocol ID
- REB19-0042
- Status last verified
- Mar 2020
- First submitted
- 30 Jul 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Campbell TA, Sanson TG. Cardiac arrest and pregnancy. J Emerg Trauma Shock. 2009 Jan;2(1):34-42. doi: 10.4103/0974-2700.43586.
PubMed 19561954Dijkman 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.
PubMed 20078586Yeomans 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.
PubMed 16215345
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Hospital Maternal Cardiac Arrests: Highlighting the Importance of the First 5 Minutes.
- ClinicalTrials.gov ID
- NCT04050631
- Acronym / sponsor ID
- REB19-0042
- Conditions
- Maternal Death During Childbirth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KidSIM Simulation ProgramResearch network
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 8 Aug 2019 (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.
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:
- 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).
- 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.
Detailed description
The investigators are planning to conduct a pilot descriptive study involving Foothill Medical Centre (FMC), Calgary. Research ethics approval will be obtained. The trial will also be registered at clinicaltrials.gov
The sessions will take place at the labor and delivery floor (L\&D) simulation lab at FMC. The proposed time for study completion is 18 months. No follow up is required for this study. The data will be collected by one of the investigators (Dr. Fatemah Qasem). In addition, the participants performance will be video recorded for further data collection and revision by the investigator team.
On the day of the simulation session, the participants will be pre-briefed to the simulation room, mannequin, and the equipment but will be naïve to the simulation scenario. The simulation scenario will involve amniotic fluid embolism (AFE) in a term pregnant parturient with singleton pregnancy. The patient will have a working epidural catheter in situ for labor analgesia and an 18G IV line. The parturient will develop cardiopulmonary collapse due to AFE requiring ACLS.
The scenario will be scripted by investigator team members. The same scenario will be used at both centers (FMC and RGH). The script will include the initial clinical vignette; vital signs; patient weight; laboratory values; planned changes in clinical status, including what and when decompensations should occur (eg, 4 minutes into scenario, the patient will progress to pulseless VT); and planned responses to actions by participants. Time 0 will be referred to the onset of the decompensation. For maintaining realism, little interaction will occur between participants and evaluators. If no one remembers to call the code team, then the emergency is managed with only L\&D staff. Although the primary focus of this study is to assess the quality of resuscitation delivered by first responders before the code team's arrival, the exercise will also allow to assess the resuscitation skills of obstetric care unit team. The scenario will end at skin incision for delivery of the fetus. Thirty minutes will be used for debriefing time as part of the hospital staff education. Data collected during the debriefing, and discussion points will used for quality improvement purposes and will not be used as part of the study results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L&D team | – | Behavioral: maternal arrest simulation on L&D floorthe first responders on L\&D floor including : anesthesia, nurses and OBGYN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care providers at L\&D floor : Anesthesia, OBGYN, Nurses
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (2 listed)
- Not BLS certified.
- Participant refusal
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 |
|---|---|---|
| maternal arrest simulation on L&D floorAFE on L\&D | Behavioural | L&D team |
Primary outcome
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 frame: 10/ minutes
oxygenation
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 frame: 100-120/minutes
chest compressions
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 frame: minutes
defibrillation
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 frame: 5 minutes
time to incision
2 secondary outcomes
Quality of CPR
Time frame: 15 mins
Quality of CPR
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 19561954Campbell TA, Sanson TG. Cardiac arrest and pregnancy. J Emerg Trauma Shock. 2009 Jan;2(1):34-42. doi: 10.4103/0974-2700.43586.
- Background: PubMed 20078586Dijkman 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.
- Background: PubMed 16215345Yeomans 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.
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.
Adam Cheng principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Death During Childbirth, run by KidSIM Simulation Program at 1 site in Canada.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatemah Qasem (40395524332, fatema.qasem@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 frame: 10/ minutes). The study lists 4 primary outcomes in all. 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 NCT04050631, which also lists 3 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 24 Mar 2020.