Clinical trial NCT05355519: Obstetric Life Support, a Curriculum to Effectively Resuscitate Pregnant Patients Experiencing Cardiac Arrest.
Official title: Advances in Patient Safety Through Simulation Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Pregnancy Related
Keywords: The Obstetric Life Support Program (OBLS)
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-05-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.
Primary purpose: OTHER

Brief summary: The objective of the study is to determine if Obstetric Life Support Program (OBLS) has an effect on the confidence and skills knowledge in participants.

Detailed description: Enrolled participants with healthcare experience will be randomized to intervention with an electronic curriculum and instructor-led course or placebo first and then will be crossed over to receive the intervention. Participants will undergo assessments pre and post intervention, as well as repeat assessments after three washout periods separated by six months each.

Eligibility criteria: Inclusion Criteria:

PH

1. All genders
2. EMS healthcare providers of all levels including basic, advanced, paramedics; firefighters, law enforcement officers, and trainees in any of these programs.
3. 18 years old or older
4. Ability to read, write and speak in English

IH

1. All genders
2. Emergency medicine providers (ED, FP, ICU) surgeons (OB), anesthesiologists, trainees of GME, and nurses from ED, FP, ICU/NICU, or OB/L\&D.
3. 18 years or older
4. Ability to read, write and speak in English

Exclusion Criteria:

1. Participants included in the pilot-testing sessions
2. Participants from other medical specialties not listed in the inclusion criteria.

Primary outcomes:
measure: Change from Baseline in the Mean Participant Knowledge Assessment
timeFrame: From baseline to immediately upon completing training
measure: Comparison of Scores Between Two Arms
timeFrame: Immediately upon completing training
Secondary outcomes:
measure: Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients
timeFrame: From baseline to 6 months
measure: Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Andrea Shields, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collier AY, Molina RL. Maternal Mortality in the United States: Updates on Trends, Causes, and Solutions. Neoreviews. 2019 Oct;20(10):e561-e574. doi: 10.1542/neo.20-10-e561.
citation: Hameed AB, Lawton ES, McCain CL, Morton CH, Mitchell C, Main EK, Foster E. Pregnancy-related cardiovascular deaths in California: beyond peripartum cardiomyopathy. Am J Obstet Gynecol. 2015 Sep;213(3):379.e1-10. doi: 10.1016/j.ajog.2015.05.008. Epub 2015 May 13.
citation: Briller J, Koch AR, Geller SE; Illinois Department of Public Health Maternal Mortality Review Committee Working Group. Maternal Cardiovascular Mortality in Illinois, 2002-2011. Obstet Gynecol. 2017 May;129(5):819-826. doi: 10.1097/AOG.0000000000001981.
citation: Jeejeebhoy FM, Zelop CM, Lipman S, Carvalho B, Joglar J, Mhyre JM, Katz VL, Lapinsky SE, Einav S, Warnes CA, Page RL, Griffin RE, Jain A, Dainty KN, Arafeh J, Windrim R, Koren G, Callaway CW; American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular Diseases in the Young, and Council on Clinical Cardiology. Cardiac Arrest in Pregnancy: A Scientific Statement From the American Heart Association. Circulation. 2015 Nov 3;132(18):1747-73. doi: 10.1161/CIR.0000000000000300. Epub 2015 Oct 6.
citation: Goodwin AP, Pearce AJ. The human wedge. A manoeuvre to relieve aortocaval compression during resuscitation in late pregnancy. Anaesthesia. 1992 May;47(5):433-4. doi: 10.1111/j.1365-2044.1992.tb02228.x.
citation: Jeejeebhoy FM, Zelop CM, Windrim R, Carvalho JC, Dorian P, Morrison LJ. Management of cardiac arrest in pregnancy: a systematic review. Resuscitation. 2011 Jul;82(7):801-9. doi: 10.1016/j.resuscitation.2011.01.028. Epub 2011 May 6.
citation: Lipman S, Cohen S, Einav S, Jeejeebhoy F, Mhyre JM, Morrison LJ, Katz V, Tsen LC, Daniels K, Halamek LP, Suresh MS, Arafeh J, Gauthier D, Carvalho JC, Druzin M, Carvalho B; Society for Obstetric Anesthesia and Perinatology. The Society for Obstetric Anesthesia and Perinatology consensus statement on the management of cardiac arrest in pregnancy. Anesth Analg. 2014 May;118(5):1003-16. doi: 10.1213/ANE.0000000000000171.
citation: King SE, Gabbott DA. Maternal cardiac arrest--rarely occurs, rarely researched. Resuscitation. 2011 Jul;82(7):795-6. doi: 10.1016/j.resuscitation.2011.03.029. Epub 2011 Apr 6. No abstract available.