Multimodal Intervention for Premature Birth
(PRIME Trial)
Trial Summary
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 data supports the effectiveness of the treatment Multimodal intervention strategy for premature birth?
Research shows that a multisensory intervention for preterm infants, guided by parents, can improve language and motor skills by age 2 to 3. Additionally, a NICU music therapy intervention called Multimodal Neurologic Enhancement has been linked to better developmental outcomes in preterm infants.12345
Is the multimodal intervention for premature birth generally safe for humans?
How is the Multimodal intervention strategy treatment for premature birth different from other treatments?
The Multimodal intervention strategy for premature birth is unique because it involves a multisensory approach provided by parents, which has been shown to improve language and motor skills in preterm infants. Unlike standard medical treatments, this approach focuses on sensory and movement experiences to support development, and it actively involves parents in the care process.25111213
What is the purpose of this trial?
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
Research Team
Brian Iriye, MD
Principal Investigator
High Risk Pregnancy Center
Eligibility Criteria
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
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.
Treatment Details
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