Obstetric Life Support, a Curriculum to Effectively Resuscitate Pregnant Patients Experiencing Cardiac Arrest.

Pregnancy Related Clinical Trial

— OBLS  

Official title:

Advances in Patient Safety Through Simulation Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355519
• Other study ID #: 22X-137
• Secondary ID: 5R18HS026169
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2022
• Source: UConn Health
• Contact: Laurie Kavanagh, MPH
• Phone: 206-399-0531
• Email: kavanagh[@]uchc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Pregnancy Related

Intervention

Other:
• Electronic curriculum and instructor-led course, then placebo
Electronic curriculum and instructor-led course
• Placebo, then electronic curriculum and instructor-led course
Electronic curriculum and instructor-led course

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Mean Participant Knowledge Assessment	Mean (standard deviation) of participant knowledge assessment scores post-training stratified by treatment arm. Minimum value is zero and maximum value is 100. A higher score means a better outcome.	From baseline to immediately upon completing training
Primary	Comparison of Scores Between Two Arms	Mean (standard deviation) of participant megacode checklist scores post-training stratified by treatment arm.; Minimum value is zero and maximum value is 200. A higher score means a better outcome.	Immediately upon completing training
Secondary	Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients	Frequency (percent) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients.	From baseline to 6 months
Secondary	Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients	Frequency (%) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients.	From baseline to 12 months

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