Obstetric Life Support Training for Cardiac Arrest in Pregnant Patients

(OBLS Trial)

Overseen By Laurie Kavanagh, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Disqualifiers: Pilot-testing participants, Other specialties

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether the Obstetric Life Support Program (OBLS) boosts participants' confidence and skills in handling cardiac emergencies in pregnant patients. It includes an online course and hands-on training sessions. Participants are healthcare providers or trainees, such as paramedics or emergency medicine staff, who can read, write, and speak English. The trial tests various methods of delivering OBLS training to determine the most effective approach. As an unphased trial, this study provides a unique opportunity to enhance skills and confidence in managing critical emergencies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Obstetric Life Support Program (OBLS) is safe for participants?

Research shows that the Obstetric Life Support Program (OBLS) helps healthcare providers improve their skills and confidence in managing cardiac arrest in pregnant patients. As an educational course, not a drug or medical device, OBLS presents no direct safety concerns. It focuses on training rather than affecting physical health.

Studies have demonstrated that OBLS effectively enhances participants' readiness and ability to handle emergencies. Since OBLS involves learning and practicing medical scenarios, no negative effects have been reported from participation. The program boosts knowledge and skills, which are crucial during real-life emergencies.

Unlike drug trials, OBLS does not have different phases, minimizing safety concerns. Participants engage in safe and controlled simulations and assessments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to handling cardiac arrest in pregnant patients through the Obstetric Life Support Program (OBLS). Unlike traditional CPR training, which doesn't specifically address the unique challenges of pregnancy, OBLS combines online cognitive assessments with an in-depth instructor-led course and simulated medical scenarios tailored for obstetric emergencies. This comprehensive training aims to equip healthcare providers with specialized skills to improve outcomes for both mothers and babies during such critical situations. By focusing on this specific area, the trial could pave the way for more effective and targeted interventions in obstetric emergencies.

What evidence suggests that the Obstetric Life Support Program (OBLS) is effective for improving confidence and skills knowledge in participants?

Research shows that the Obstetric Life Support Program (OBLS) helps healthcare professionals prepare for heart emergencies in pregnant women. Studies have found that OBLS boosts both confidence and knowledge in managing these situations. In this trial, participants in the "Curriculum and Instructor-Led Course" arm will engage in OBLS training, which includes practicing in realistic scenarios. This evidence suggests that OBLS effectively improves the skills needed for emergencies involving pregnant patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Andrea Shields, MD

Principal Investigator

UConn Health

Are You a Good Fit for This Trial?

This trial is for EMS providers, firefighters, law enforcement officers, emergency medicine providers, surgeons (OB), anesthesiologists, and nurses in specific departments. Participants must be at least 18 years old and able to communicate in English. Those involved in pilot-testing or from other medical specialties are excluded.

Exclusion Criteria

People from medical specialties not mentioned in the inclusion criteria are not allowed to participate.

Participants included in the pilot-testing sessions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Intervention

Participants undergo an electronic curriculum and instructor-led course or placebo, followed by crossover to receive the intervention

Immediately upon completing training

Washout Period 1

Participants undergo a washout period before reassessment

6 months

Reassessment

Participants return for reassessment and participate in simulated medical scenarios

Immediately upon completing training

Washout Period 2

Participants undergo a second washout period before final assessment

6 months

Final Assessment

Participants take the online cognitive assessment again

Immediately upon completing training

Follow-up

Participants are monitored for changes in confidence and knowledge assessment scores

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Obstetric Life Support Program (OBLS)

Trial Overview The study is testing the Obstetric Life Support Program's impact on confidence and skills knowledge of healthcare professionals. It involves an electronic curriculum with instructor-led courses compared against a placebo approach.

How Is the Trial Designed?

Group I: Curriculum and Instructor-Led Course Active Control 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826210

Obstetric Life Support Education for Maternal Cardiac Arrest This randomized clinical trial demonstrated the OBLS program's effectiveness in enhancing health care professionals' readiness to treat ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568455/

Obstetric Life Support Education for Maternal Cardiac Arrest This randomized clinical trial demonstrated the OBLS program's effectiveness in enhancing health care professionals' readiness to treat ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05355519

Study Details | NCT05355519 | Obstetric Life Support, a ... 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666520425001754

Cardiac arrest in the pregnant patient – Using simulation to ... Participants also reported increased confidence with managing cardiac arrest in pregnant patients and satisfaction with the simulation. Knowledge and confidence ...

5. contemporaryobgyn.net contemporaryobgyn.net/view/improved-maternal-cardiac-arrest-management-reported-from-obstetric-life-support-training

Improved maternal cardiac arrest management reported ... A study found that Obstetric Life Support education significantly improves health care providers' readiness and outcomes in maternal cardiac ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39546311

Obstetric Life Support Education for Maternal Cardiac Arrest Main outcomes and measures: The primary outcome was cognitive scores. Secondary outcomes included megacode scores rated by experienced OBLS ...

7. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000300

Cardiac Arrest in Pregnancy | Circulation Despite these problems, recent data show that the rate of survival to hospital discharge after maternal cardiac arrest may be as high as 58.9%, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146000511000073

The Case for OBLS: A Simulation-based Obstetric Life ... However, the medical literature suggests that obstetrical providers are not optimally trained to render care during maternal cardiopulmonary arrest.