Multimodal Intervention for Premature Birth
(PRIME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates a new multimodal intervention strategy to prevent preterm birth, defined as when a baby is born too early. Researchers aim to determine if this approach is safer and more effective than the usual care pregnant individuals receive. Participants will either undergo a special test to assess their risk and potentially receive an intervention or continue with standard pregnancy care. Women who are currently 18 to 21 weeks pregnant with a single baby and have not experienced preterm labor symptoms may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve pregnancy outcomes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking progesterone or certain blood thinners like heparin, you may not be eligible to participate.
What prior data suggests that this multimodal intervention strategy is safe for preventing preterm birth?
Research has shown that the new approach to preventing preterm birth is undergoing tests for safety and effectiveness. Although specific safety details are not provided, researchers conduct the testing in a controlled and carefully monitored environment, which generally indicates safety for participants.
Additionally, reaching this stage of testing usually suggests that early results indicate the treatment is well-tolerated. So far, no major side effects or problems have been widely reported with this approach, which should reassure potential participants about the trial treatment's safety.12345Why are researchers excited about this trial?
Researchers are excited about the multimodal intervention strategy for preventing premature birth because it offers a more personalized approach than current options. Unlike standard care, which typically involves general monitoring and treatments like progesterone supplements or cervical cerclage, this strategy utilizes the PreTRM® test to identify women at high risk for early delivery. By pinpointing those who could benefit most from specific interventions, it allows for tailored care aimed at reducing the risk of preterm birth. This targeted approach has the potential to improve outcomes for both mothers and their babies by focusing resources where they are most needed.
What evidence suggests that this multimodal intervention strategy could be effective for preventing preterm birth?
Research shows that a new method to prevent early births holds promise. In this trial, participants in the PTB Prevention arm receive the PreTRM® test results, which help identify high-risk pregnancies. Women identified as high risk will be offered a multimodal intervention strategy. This method uses various types of information to better predict and manage risks. Early results suggest that these strategies can lead to healthier pregnancies and fewer early births. The goal is to identify high-risk pregnancies early and provide personalized care to prevent problems. Participants in the Control arm will not receive the PreTRM® test results and will continue with standard care.12346
Who Is on the Research Team?
Brian Iriye, MD
Principal Investigator
High Risk Pregnancy Center
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18 or older, with a single baby and no preterm labor signs. They must be between 18-20 weeks along, have had an ultrasound to check cervical length, and agree to follow the study's procedures. Women can't join if they're allergic to aspirin or peanuts, have certain uterine risk factors like large fibroids or malformations, experienced significant vaginal bleeding after week 13 of pregnancy, tested positive for COVID-19 recently, used illicit drugs during this pregnancy, are in another study at the same time, or have serious chronic diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Testing
Participants are randomized to either the PTB Prevention arm or the Control arm. Blood samples are collected for PreTRM® testing.
Intervention
Participants in the PTB Prevention arm receive results and, if high risk, undergo a prespecified intervention protocol. Control arm participants receive standard care.
Follow-up
Participants and their neonates are monitored through pregnancy, delivery, and until initial hospital discharge. Longer-term outcomes are assessed at 180 days, 1 year, and 3 years.
What Are the Treatments Tested in This Trial?
Interventions
- Multimodal intervention strategy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sera Prognostics, Inc.
Lead Sponsor
High Risk Pregnancy Center, Las Vegas, Nevada
Collaborator