Understanding Fetal Neurodevelopment During Pregnancy Seeking Participants
In the United States, about 7% of women use prescription opioids pain relievers during pregnancy, an increase of more than 130% over the last decade. Signs and symptoms of neonatal opioid withdrawal occur in up to 50% of neonates born of mothers using opioids during pregnancy. Signs of withdrawal usually begin within 72 hours after birth but cannot be predicted based upon opioid dosage and may result in a longer nursery stay for these neonates or need for pharmacologic treatment. The intent of this study is to seek biomarkers prior to birth in maternal blood that originate in the fetus that may better predict which babies may or may not be at risk of withdrawal to better guide neonatal nursery stay or need for treatment.
WHAT IS THE STUDY?
The study collects maternal blood and urine at various time points during pregnancy and, selectively, blood, cord blood, and placental biopsies (the placenta is normally discarded after birth) at the time of delivery. Information about the pregnancy and its outcome will also be collected after birth. All information will be de-identified so that participants cannot be individually identified. These samples will be used by investigators at the University of Washington to identify biomarkers that may predict and identify babies at risk for neonatal withdrawal from opioids (methadone & buprenorphine) used by mothers and potentially allow early treatment or prevention.
WHAT IS THE GOAL OF THE STUDY?
The intent of the these studies is to search for fetal-specific biomarkers prior to birth from maternal blood that will predict babies at risk of neonatal withdrawal
ARE YOU ELIGIBLE?
We are asking pregnant women currently using methadone or buprenorphine to participate. The only exclusion criteria is pregnancies with major fetal anomalies (birth defects). Whether or choose to participate or not, your pregnancy care at UWMC will not be affected.
WHAT TO EXPECT?
If you choose to participate, we will obtain blood and urine samples during the 2nd and 3rd trimester of your pregnancy. These collections, whenever possible, will be obtained during regularly scheduled visits and blood draws (typically at 19-21 weeks and at 33-35 weeks of pregnancy) and in selected cases, maternal blood, cord blood, and placental biopsies at the time of delivery. All patient information will be de-identified prior to its use.
WHO DO I CONTACT?
If you would like more information, please contact us by phone at 206-822-9702 or by email at firstname.lastname@example.org
HOW IS THIS PROJECT FUNDED?
This project is funded by grants from the National Institutes of Health.