Maternal Death During Childbirth Clinical Trial
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:
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. 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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04060667 -
Wireless Physiologic Monitoring in Postpartum Women
|
N/A |