Evaluating the safety and efficacy of preterm birth prevention strategies.
High Risk Pregnancy Center has partnered with Sera Prognostics and several other influential community and university maternal-fetal medicine centers across the United States to conduct a prospective, randomized, controlled study on preterm birth. This study aims to reduce the incidence of adverse pregnancy outcomes—specifically concerning reduction of preterm birth in asymptomatic pregnancies.
A preterm birth is any infant born before 37 weeks of gestation. Infants born preterm have a higher risk for mortality and health and developmental problems than infants born at full term. Preterm birth costs the United States over $26 billion in costs both directly and indirectly and is the largest single cause of neonatal death and disability.
This is the largest research study on high-risk pregnancy in the last two decades, with thousands of participants. It aims to evaluate the safety and efficacy of preterm birth (PTB) prevention strategies versus standard-of-care pregnancy management in patients flagged at increased risk for preterm delivery by Sera Prognostics novel blood test drawn from 18-20 weeks of pregnancy.
Dr. Brian Iriye is a board-certified maternal-fetal physician at High Risk Pregnancy Center and the lead investigator for this study.
“Preterm birth rates in the U.S. have steadily increased over the last several years and continue to be a major problem vexing pregnancy,” explains Dr. Iriye, “Despite all influences, we haven’t made a significant dent in preterm birth rates. Preterm birth is a leading cause of prenatal complications and prenatal death. Decreasing these rates must be a top priority among fetal-maternal specialists and OB-GYNs nationwide.”
According to Dr. Iriye, this study can potentially benefit all participants: “The mothers to help protect their infants with key information, the doctors who will know ahead of time to prepare moms, and the babies who will be better protected from preterm birth, death, and handicaps. It may even help alleviate the economic burden on the medical system. It’s time to utilize the science and techniques we have now to focus on decreasing preterm births, their associated risks, and work to improve health outcomes for moms and their newborns.”
Preterm Birth (PTB) Prevention Strategy: Explained
Primary PTB prevention strategies are beneficial for all pregnancies and include health optimizations such as:
- Weight optimization
- Nutritional supplementation
- Stress management
- Smoking cessation
Secondary PTB prevention strategies supplement primary strategies and may be used in high-risk pregnancies. They can include (but are not limited to):
- Low-dose aspirin for moms at risk of preeclampsia
- Progesterone for moms with prior spontaneous PTB
- Progesterone for moms with short mid-trimester cervical length (less than 25 mm)
- Cervical length screening in moms with a history of PTB with the placement of cerclage in those with a short cervix
- Pre-pregnancy treatment of periodontal disease
- Weekly home nursing calls to monitor signs and symptoms of preterm birth
Why Are Preterm Birth Prevention Strategies Important?
According to the 2022 March of Dimes report card, the U.S. preterm birth rate in the United States increased from 10.1% in 2020 to 10.5% in 2021—earning us in Nevada an abysmal D+ rating.
At first glance, these statistics may not appear alarming. However, compared with other wealthy countries, it tells a shocking story of poor outcomes in one of the world’s most developed countries.
Preterm birth prevention strategies help ensure more infants are carried to term, eliminating several health risks, including problems with:
- Breathing
- Heart function
- Brain function
- Temperature regulation
- Gastrointestinal system
- Red blood cells
- Metabolism
- Immune system
Dr. Iriye and his colleagues agree it’s well-past time to rewrite this story and firmly believe their high risk pregnancy case study is a must-have first step.
“I hope this research study on high risk pregnancy gets us on a new track to decrease these problems. The scary thing is that 80 percent of moms who deliver preterm infants don’t have preexisting risk factors. So the screening by historical factors alone is very inaccurate.”
They aim to prove that multimodal intervention protocols for higher-risk pregnancies may drastically improve maternal and neonatal health-related outcomes.
The Clinical Study: Explained
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal Outcomes (PRIME)
After enrollment and blood draw, participants will be categorized into two groups at random: PTB prevention (test group) or standard of care management (control group)
Participants randomized to the preterm birth prevention strategy will receive either:
- Low-risk results and hence routine standard of care pregnancy management or
- High-risk results and undergo multimodal intervention protocol reserved for higher-risk pregnancies based on the results of a laboratory-developed test, PreTRM®.
The protocol utilizes well-established high-risk pregnancy interventions to improve maternal and neonatal health-related outcomes.
| Test Group – PTB Prevention Protocols | Control Group – Standard of Care |
| PreTRM blood sample drawn at 18-20weeks Results provided to the patient, lead investigator, and primary care physician (indicated as “higher risk” or “not higher risk”) |
PreTRM blood sample drawn at 18-20 weeks Results not provided |
The Test Group will then be broken down further into two categories based on their test results:
| Not Higher Risk (less than 15% risk of PTB) | Higher Risk (Greater than 15% risk of PTB) |
| All participants in this group will receive standard of care for the duration of their pregnancy through hospital discharge. | All participants in this group must complete a secondary consenting process to receive a prespecified intervention protocol. |
All patients will be closely monitored throughout their pregnancy and delivery until hospital discharge to assess the course of pregnancy, labor, and any related maternal or fetal complications.
Birth outcomes will be obtained, and babies will be followed through hospital discharge.
All infants will be assessed at 180 days, one year, and three years of life using the HealthCore Integrated Research Database to evaluate longer-term outcomes and costs associated with preterm delivery.
Read Full Study Details
This randomized, controlled study began in November 2020 with an estimated primary completion date of December 30, 2023, and an estimated study completion date of December 30, 2026
HRPC Is Devoted to Protecting the Health of Mothers-To-Be and Their Unborn Babies
As obstetric subspecialists, our experienced maternal-fetal medicine doctors offer the most advanced testing and treatment options to reduce pregnancy risks from preconception to post-pregnancy.
Our team continues to lead the way in technology, procedures, and commitment to all the growing families in our care and community.
If you’re living with a high-risk pregnancy or want to take the next step in growing your family while reducing the risk of preterm labor and its associated complications, we are here to help.
Schedule an appointment to get started today.