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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

Must not have

Subject has current diagnosis of polyhydramnios

One or more of the following uterine risk factors are present: fibroids > 5.0cm, uterine malformation, history of classical cesarean section, history of prior uterine surgery with trans-myometrial penetration (excludes low transverse cesarean section)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 year infant follow-up

Awards & highlights

No Placebo-Only Group

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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not showing any signs of early labor and my water hasn't broken.

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I am 18 years old or older.

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I am between 18 and 21 weeks pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with polyhydramnios.

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I have a large fibroid, uterine malformation, or a history of certain uterine surgeries.

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My unborn baby has been diagnosed with a major anomaly or genetic issue.

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I am allergic to peanuts or peanut oil.

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I have taken blood thinners since my last menstrual period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 year infant follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of neonatal hospital stay

Morbidity - disease rate

Secondary study objectives

Increase gestation

Length of NICU hospital stay for neonates reduction

Other study objectives

Anxiety

COVID-19 exploratory

+56 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met