Multimodal Intervention for Premature Birth

(PRIME Trial)

Not currently recruiting at 20 trial locations

Overseen By Adrienne Bodner

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sera Prognostics, Inc.

Must not be taking: Progesterone, Heparin, Illicit drugs, others

Disqualifiers: Prior preterm delivery, Major fetal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

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

I have had an ultrasound to check my baby's development and my cervical length.

This is a singleton intrauterine pregnancy

Exclusion Criteria

Singleton gestation reduced from an original multiple gestation via embryonic reduction or vanishing twin

The subject has a planned cesarean section or induction of labor prior to 37 0/7 weeks gestation

The subject has experienced vaginal bleeding after 13 6/7 weeks gestation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Testing

Participants are randomized to either the PTB Prevention arm or the Control arm. Blood samples are collected for PreTRM® testing.

2 weeks

1 visit (in-person)

Intervention

Participants in the PTB Prevention arm receive results and, if high risk, undergo a prespecified intervention protocol. Control arm participants receive standard care.

Duration of pregnancy

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.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal intervention strategy

Trial Overview

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).

How Is the Trial Designed?

Group I: PTB Prevention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Sera Prognostics, Inc.

Lead Sponsor

Trials

4

Recruited

18,200+

High Risk Pregnancy Center, Las Vegas, Nevada

Collaborator

Trials

1

Recruited

6,500+

Published Research Related to This Trial

Premature infants showed positive responses to multiple sensory stimulation interventions, with benefits observed both immediately and lasting up to 2 years.

To enhance nursing research on sensory stimulation for premature infants, it is important to establish a theoretical framework, provide detailed descriptions of infant samples and environments, and tailor stimulation methods to preserve the infants' epigenetic integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary research of multimodal stimulation of premature infants: an integrated review of the literature. Mueller, CR.[2005]

Out of 279 systematic reviews analyzed, only 70.61% considered the impact of interventions/controls on adverse events, while other important effect modifiers like treatment duration (21.15%) and dosage (24.73%) were rarely investigated.

The study highlights a significant gap in current systematic reviews regarding the assessment of effect modifiers on harmful effects, suggesting that methodological guidelines should include these factors to improve the evaluation of safety in healthcare interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. Zhou, X., Yang, X., Cai, F., et al.[2023]

A multisensory intervention program guided by parents for preterm infants in the neonatal intensive care unit led to significantly better outcomes in receptive language and fine-motor skills at 2 to 3 years of age, as assessed by the Bayley Scale.

The intervention particularly benefited boys in terms of language skills, while parental stress levels remained unchanged, suggesting that the program can enhance child development without increasing parental stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of a multisensory intervention for preterm infants provided by parents, on developmental abilities and on parental stress levels. Gabis, LV., Hacham-Pilosof, K., Yosef, OB., et al.[2015]

Citations

1.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2837055

External Validation of a Multimodal Model for Predicting ...

This prognostic study evaluates the performance of a multimodal prognostic model developed for predicting outcomes in extremely preterm ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04301518

Study Details | NCT04301518 | Prematurity Risk ...

This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11756159/

Evaluating the impact of a multimodal perinatal education ...

This study aims to assess the impact of a holistic perinatal education program on birth preparedness, mental health, and birth outcomes among rural primiparous ...

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clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT04301518

Prematurity Risk Assessment Combined With ...

This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of ...

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jneonatalsurg.com

jneonatalsurg.com/index.php/jns/article/download/3026/2721/14309

Exploring Multimodal Machine Learning Approaches For ...

Data from 3,006,989 pregnant women in 2019 and 3,039,922 pregnant women in 2018 were used to build the model and external validation, respectively. Out of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11070639/

Computational Approaches for Predicting Preterm Birth ...

Identifying PTB outcomes and early interventions are critical to mitigating these morbidities. Traditionally, single risk factors, such as maternal age or ...