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Multimodal Intervention

Multimodal Intervention for Premature Birth (PRIME Trial)

N/A
Waitlist Available
Led By Brian Iriye, MD
Research Sponsored by Sera Prognostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has no signs and/or symptoms of preterm labor and has intact membranes
Subject is 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year infant follow-up
Awards & highlights

PRIME Trial Summary

This trial looks at whether a strategy to prevent preterm birth is better than usual care in reducing adverse pregnancy outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests a multimodal intervention strategy aimed at preventing premature birth compared to standard care. It's designed as a prospective (looking forward in time), randomized (participants are randomly assigned) controlled study (one group receives the test intervention; another—the control—does not).See study design
What are the potential side effects?
Since specific interventions aren't detailed here beyond 'multimodal,' side effects cannot be accurately listed without more information on what these interventions entail.

PRIME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not showing any signs of early labor and my water hasn't broken.
Select...
I am 18 years old or older.
Select...
I am between 18 and 21 weeks pregnant.

PRIME Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 year infant follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 year infant follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Length of neonatal hospital stay
Morbidity - disease rate
Secondary outcome measures
Increase gestation
Length of NICU hospital stay for neonates reduction
Other outcome measures
Anxiety
Anxiety
COVID-19 exploratory
+56 more

PRIME Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PTB PreventionExperimental Treatment1 Intervention
Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the PTB Prevention arm will receive the PreTRM® test results. If high risk, women will be consented to take part in the intervention. Those not higher risk will continue on with standard of care.
Group II: ControlActive Control1 Intervention
Approximately 6500 women will be screened, consented, and have the PreTRM® test sample collected. Randomization will occur 1:1 at each site. Those randomized to the Control arm will not receive the PreTRM® test results. Control arm subjects will continue on with standard of care.

Find a Location

Who is running the clinical trial?

Sera Prognostics, Inc.Lead Sponsor
3 Previous Clinical Trials
11,719 Total Patients Enrolled
High Risk Pregnancy Center, Las Vegas, NevadaOTHER
Brian Iriye, MDPrincipal InvestigatorHigh Risk Pregnancy Center

Media Library

Multimodal intervention strategy (Multimodal Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04301518 — N/A
Preterm Labor Research Study Groups: PTB Prevention, Control
Preterm Labor Clinical Trial 2023: Multimodal intervention strategy Highlights & Side Effects. Trial Name: NCT04301518 — N/A
Multimodal intervention strategy (Multimodal Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04301518 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple venues that offer this trial?

"Patient recruitment is currently underway across 12 different facilities, with locations in San Diego, New york and New Orleans among others. It is recommended that participants pick the clinic nearest them to reduce any travel-related burdens."

Answered by AI

What is the aggregate amount of participants in this clinical trial?

"To complete this clinical trial, 6500 adequately qualified participants are needed. Potential subjects can join the study at either UCSD in San Diego or Mt Sinai in New york City."

Answered by AI

Are investigators currently looking for new participants for this trial?

"According to the details on clinicaltrials.gov, this study is actively looking for individuals to participate in it; it has been available since November 6th 2020 and was last updated on July 25th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
Michigan
Virginia
How old are they?
18 - 65
What site did they apply to?
High Risk Pregnancy Center
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
2020. "Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04301518.
~1472 spots leftby Apr 2025
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