Prematurity Risk assessment combined with clinical Interventions for improving neonatal outcoMEs: The PRIME Study

This study is being done to identify women at higher risk of giving birth preterm (before 37 weeks of pregnancy) and providing additional treatment to them. Then the study will compare their pregnancies and babies’ birth with similar women who do not know if they are at increased risk of giving birth preterm.

Preterm birth can result in serious health problems for a newborn baby. These could include problems breathing when they need oxygen or use of a machine to help them breathe, brain function issues that may affect learning, and serious issues with their gut. The PreTRM® test is a blood test that looks at certain proteins in your blood. It has been shown to predict a woman’s risk of giving birth preterm. For the purposes of this study, all women will have blood collected for testing, but only half of women will receive a PreTRM® test result. The result will indicate that a woman is at Higher Risk if her risk of preterm birth is at least two times greater than the usual risk for all women. Women with a test result that is less than two-times greater the usual risk will receive a "Not Higher Risk" test result.

When a woman is found to have a higher risk of preterm birth, there is not a typical treatment. This study will be offering interventions to see how they may affect preterm birth and preterm babies. This study will also compare hospital stays of preterm and term babies. If eligible participant and their baby are insured by a Health Plan affiliated with Elevance Health, the sponsors may also review the baby’s medical claims information to see how often the baby comes back to the hospital and what illnesses and treatments they have until they are three years old. Up to 6,500 subjects will participate in this study.

Inova Fairfax Medical Campus
300 Gallows Rd.
Falls Church, VA 22042

• You are 18 years of age or older
• Your gestational age is currently within 18 and 20 weeks using best estimated due date
• Singleton intrauterine pregnancy

• You had a prior spontaneous preterm delivery (gestational age at birth less than 37 weeks gestation)
• You have taken progesterone or progesterone-derivative medication after 13 weeks gestation
• You have experienced vaginal bleeding after 13 weeks gestation
• You have planned cesarean section or induction of labor prior to 37 weeks gestation
• Allergic to aspirin, peanuts and/or peanut oil
• You are currently participating in any other interventional research studies