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

NCT ID: NCT05355519

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-21

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Megacode evaluators will be masked to the arm in which the participants are randomized.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Curriculum and Instructor-Led Course

Participants first complete an online cognitive assessment. Once complete, staff email the electronic curriculum for participants to read. On a specific day, participants will go to the designated center to participate in an instructor-led course and simulated medical scenarios and complete megapode and online cognitive assessment. After a washout period of six months, participants return to the designated center to participate in simulated medical scenarios and complete the online cognitive assessment again. After a second washout period of six months, participants will take the online cognitive assessment again.

Group Type ACTIVE_COMPARATOR

Electronic curriculum and instructor-led course, then placebo

Intervention Type OTHER

Electronic curriculum and instructor-led course

Placebo

On a specific day, participants will go to a designated center to complete an online cognitive assessment and participate in simulated medical scenarios. Once complete, study staff will email the electronic curriculum for participants to read. After a washout period of six months, participants will return to the designated center to participate in an instructor-led course and simulated medical scenarios and complete a megapode and online cognitive assessment. After a second washout period of six months, participants will take an online cognitive assessment again.

Group Type PLACEBO_COMPARATOR

Placebo, then electronic curriculum and instructor-led course

Intervention Type OTHER

Electronic curriculum and instructor-led course

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electronic curriculum and instructor-led course, then placebo

Electronic curriculum and instructor-led course

Intervention Type OTHER

Placebo, then electronic curriculum and instructor-led course

Electronic curriculum and instructor-led course

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Shields

Associate Professor of Obstetrics & Gynecology Division of Maternal Fetal Medicine Program Director, Maternal Fetal Medicine Fellowship University of Connecticut School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrea Shields, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UConn Health

Farmington, Connecticut, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laurie Kavanagh, MPH

Role: CONTACT

206-399-0531

Sheila Thurlow, MSN

Role: CONTACT

860-679-4637

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31575778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25979616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28383382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26443610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1599071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21549495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24781570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21524838 (View on PubMed)

Shields AD, Vidosh J, Minard C, Thomson B, Annis-Brayne K, Murphy M, Kavanagh L, Roth CK, Lutgendorf MA, Birsner ML, Rahm SJ, Becker LR, Mosesso V, Schaeffer B, Streitz M, Bhalala U, Gresens A, Phelps J, Sutton B, Wagner R, Melvin LM, Zacherl K, Karwoski L, Behme J, Hoeger A, Nielsen PE. Obstetric Life Support Education for Maternal Cardiac Arrest: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445295. doi: 10.1001/jamanetworkopen.2024.45295.

Reference Type DERIVED
PMID: 39546311 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R18HS026169

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

22X-137

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Care After Resuscitation
NCT02275234 COMPLETED
Automated Real-time Feedback on CPR Study
NCT00539539 COMPLETED PHASE2