The OPRU Network provides the expert infrastructure needed to test therapeutic drugs during pregnancy. It allows researchers to conduct safe, technically sophisticated, and complex studies that will help clinicians protect women’s health, improve birth outcomes, and reduce infant mortality.
A number of factors influence pharmacology during both normal and abnormal pregnancies, such as a lengthened period of intestinal transfer, increased cardiac output, and altered plasma sex hormone composition. However, very little is known about the effects of these variables on drugs that are necessary for the health and well-being of pregnant women and their fetuses.
The mission of the OPRU network is to improve the safety and effective use of therapeutic drugs in women during pregnancy and lactation. The overall goal of the OPRU is to promote and facilitate cooperative multidisciplinary research to enhance the understanding of obstetric pharmacokinetics and pharmacodynamics.
The Network was established in 2004 within the NICHD Obstetric and Pediatric Pharmacology (OPP) Branch (now the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)) and currently comprises four research units around the country, plus a Data Coordinating Center (DCC).
Funded through the U10 cooperative agreement mechanism, each OPRU contains three components:
- A pharmacology component that conducts pharmacokinetic, pharmacodynamic, and pharmacogenetic or pharmacogenomic studies
- A clinical studies component that tests the disposition and efficacy of drugs whose pharmacology is affected by pregnancy
- A multidisciplinary basic or nonclinical research component to investigate the mechanisms of drug disposition and response in pregnancy
Current OPRU research topics include (but are not limited to) studies of the efficacy, pharmacology, placental transfer, and placental biotransformation of drugs and therapeutics to:
- Treat gestational diabetes and type II diabetes, such as glyburide, metformin, and rosiglitazone
- Alter uterine activity, such as those used to delay or prevent preterm birth
- Treat severe nausea and other side effects of pregnancy
- Treat other serious conditions in pregnant women, including cancer, organ transplant rejection, and high blood pressure
Visit the OPRU Web site for a complete list of current studies.
RTI International is currently the DCC for the OPRU.