Cardiac ArrestOBLSNCT05355519
Obstetric Life Support, a Curriculum to Effectively Resuscitate Pregnant Patients Experiencing Cardiac Arrest.
A study of Cardiac Arrest and Pregnancy Related, run by UConn Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Pregnancy Related
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- PH
- All genders
- EMS healthcare providers of all levels including basic, advanced, paramedics; firefighters, law enforcement officers, and trainees in any of these programs.
- 18 years old or older
- Ability to read, write and speak in English
- IH
Show all 10Show fewer
- All genders
- Emergency medicine providers (ED, FP, ICU) surgeons (OB), anesthesiologists, trainees of GME, and nurses from ED, FP, ICU/NICU, or OB/L\&D.
- 18 years or older
- Ability to read, write and speak in English
Who cannot join
- Participants included in the pilot-testing sessions
- Participants from other medical specialties not listed in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UConn Health
Farmington, Connecticut, 06030
Andrea Shields, MD, MS
About this study
Official title: Advances in Patient Safety Through Simulation Research
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.
Read the 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.
- Conditions
- Cardiac Arrest, Pregnancy Related
- Being tested
- Electronic curriculum and instructor-led course, then placebo, Placebo, then electronic curriculum and instructor-led course
- Keywords
- The Obstetric Life Support Program (OBLS)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic curriculum and instructor-led course, then placeboOther
Electronic curriculum and instructor-led course
Placebo, then electronic curriculum and instructor-led courseOther
Electronic curriculum and instructor-led course
| Study group | Role | What they receive |
|---|---|---|
| Curriculum and Instructor-Led Course | Active comparator | 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. Receives: Other: Electronic curriculum and instructor-led course, then placebo |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo, then electronic curriculum and instructor-led course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to immediately upon completing training
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.
Measured: Immediately upon completing training
Secondary outcomes (2)
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.
Measured: From baseline to 6 months
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.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Oct 2021
- Primary completionJan 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Andrea Shields, UConn Health
- Investigators
- Andrea Shields, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355519
- Sponsor's protocol ID
- 22X-137
- Other IDs
- 5R18HS026169
- Acronym
- OBLS
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31575778Hameed 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.
PubMed 25979616Briller 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.
PubMed 28383382Jeejeebhoy 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.
PubMed 26443610Goodwin 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.
PubMed 1599071Jeejeebhoy 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.
PubMed 21549495Lipman 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.
PubMed 24781570King 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.
PubMed 21524838Shields 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.
PubMed 39546311
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advances in Patient Safety Through Simulation Research
- ClinicalTrials.gov ID
- NCT05355519
- Acronym / sponsor ID
- OBLS / 22X-137
- Conditions
- Cardiac Arrest, Pregnancy Related
- Keywords
- The Obstetric Life Support Program (OBLS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 2 May 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.
| Arm | Type | Receives |
|---|---|---|
| Curriculum and Instructor-Led Course | Active comparator | Other: Electronic curriculum and instructor-led course, then placeboParticipants 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. |
| Placebo | Placebo comparator | Other: Placebo, then electronic curriculum and instructor-led courseOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- PH
- All genders
- EMS healthcare providers of all levels including basic, advanced, paramedics; firefighters, law enforcement officers, and trainees in any of these programs.
- 18 years old or older
- Ability to read, write and speak in English
Key exclusion criteria (2 listed)
- Participants included in the pilot-testing sessions
- Participants from other medical specialties not listed in the inclusion criteria.
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 |
|---|---|---|
| Electronic curriculum and instructor-led course, then placeboElectronic curriculum and instructor-led course | Other | Curriculum and Instructor-Led Course |
| Placebo, then electronic curriculum and instructor-led courseElectronic curriculum and instructor-led course | Other | Placebo |
Primary outcome
Change from Baseline in the Mean Participant Knowledge Assessment
Time frame: From baseline to immediately upon completing training
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.
Comparison of Scores Between Two Arms
Time frame: Immediately upon completing training
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.
2 secondary outcomes
Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients
Time frame: From baseline to 6 months
Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients
Time frame: From baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 31575778Collier 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.
- Background: PubMed 25979616Hameed 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.
- Background: PubMed 28383382Briller 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.
- Background: PubMed 26443610Jeejeebhoy 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.
- Background: PubMed 1599071Goodwin 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.
- Background: PubMed 21549495Jeejeebhoy 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.
- Background: PubMed 24781570Lipman 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.
- Background: PubMed 21524838King 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.
- Derived from this study: PubMed 39546311Shields 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Andrea Shields, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiac Arrest and Pregnancy Related, run by UConn Health at 1 site in United States.
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 10 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 2 May 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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 Laurie Kavanagh, MPH (206-399-0531, kavanagh@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Mean Participant Knowledge Assessment (time frame: From baseline to immediately upon completing training). The study lists 2 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 NCT05355519, which also lists 9 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 2 May 2022.