Preterm Birth Prevention Study

Clinical Research Program

Preterm Birth Prevention Study

Participate in a paid study to assess prematurity risk and preterm birth prevention strategy

Clinical Research Partners is partnering with VPFW to offer a paid clinical study of prematurity risk assessment combined with clinical interventions for improving neonatal outcomes. Learn more below and see if you qualify to participate.

Purpose of the Study

This is a prospective, randomized, controlled study to evaluate the safety and efficacy of preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.

About the PRIME Preterm Birth Prevention Study

The Prematurity Risk assessment combined with clinical Interventions for improving neonatal outcoMEs study will use a preterm birth prevention strategy to improve the health of mothers and babies.

The PRIME study uses the PreTRM® Test to identify women at higher risk for preterm birth. Women will be randomized to receive their test results or not. Women who receive results showing higher risk of preterm birth will be offered treatments beyond regular pregnancy care to try to improve the pregnancy outcome for mother and baby. The baby’s outcome will be followed until 3 years of age through review of records to help doctors further understand the health of the child beyond birth.

The PreTRM® Test is a single blood draw used to analyze proteins within the blood during pregnancy. All subjects in the study will have blood collected for the PreTRM® Test between weeks 19 1/7 and 20 6/7. Depending on whether you are high-risk, participants have a 1 in 3 chance of receiving intervention. The drug is a PV dose of progesterone (200 mg) and PO dose of Aspirin (81 mg) – taken daily up to delivery or 37 weeks gestation, whichever occurs first.

PreTRM® results give the risk for preterm birth. In the PRIME study, the results will tell the mom if she is “Higher Risk” or Not Higher Risk” for preterm birth. Subjects will be randomized after the blood draw, so only half of participants receive a test result (the prevention strategy group). Half of the subjects will not receive results (the control group) and will continue pregnancy care as usual.

What is preterm birth?

Also known as premature birth, preterm birth refers to babies that are born before 37 weeks of pregnancy. Preterm birth can lead to health problems and longer stays in the newborn intensive care unit (NICU). Treatment for those at higher risk of preterm birth can hopefully improve these outcomes.

Preterm Birth Statistics

• One in ten babies is born before 37 weeks
• Premature birth is the leading cause of infant mortality and morbidity in the U.S. and worldwide
• Premature birth far exceeds other pregnancy risks
• 40% of preterm births occur to first-time moms
• Up to 50% of women delivering prematurely have no known risks
• Traditional methods fail to identify over 80% of women who go on to have a preterm baby

Eligibility for the Preterm Birth Study

You may qualify to participate in this study if:

• You are healthy and age 18 or older
• Your gestational age is currently between 19 1/7 weeks and 20 6/7 weeks.
• Your current pregnancy is a singleton intrauterine pregnancy (no vanishing twins)
• You have no signs and/or symptoms of preterm labor, no vaginal bleeding, and you have intact membranes
• You have had a 2nd trimester anatomic ultrasound by the date of enrollment, but no earlier than 18 weeks gestation
• You do not have any allergies to aspirin or peanuts and/or peanut oil used in exogenous progesterone formulation
• Other requirements may apply

Commitment

The study length is up to three visits if you are high-risk. Labs are drawn in-office through LabCorp at the Koger Center VPFW location. There will be follow-up from the study team until birth. (Anthem patients will be followed-up with for up to 3 years after birth.)

Compensation

• $25 Target gift cards for blood draw
• $20 for completing all anxiety assessment questionnaires (4 total)

Questions?

If you have any questions about participating in the PRIME research study, call Madison at Clinical Research Partners, 804-893-0645.

Interested in participating in a paid clinical research trial at VPFW?

If you’d like to participate in a clinical research trial, please complete the form below and we will reach out as studies become available. Thank you for helping to move science forward.