Northwestern University IRB STU00204599
Principal Investigators:Katherine L. Wisner, MD MS (Department of Psychiatry), Emily Miller, MD MPH (Department of Obstetrics and Gynecology), Catherine Stika, MD (Department of Obstetrics and Gynecology), Dr. Jody Ciolino, PhD (Department of Preventative Medicine)
Why is this research study important?
The purpose of this research is to understand changes in a woman’s body during pregnancy, specifically how the body processes medication during pregnancy.
We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimesters.
Drug metabolism is sometimes controlled by certain genes in the body. This study will be examining the up-regulation, or “speeding up” of a certain gene called CYP3A4, a gene that helps the body process Nifedipine, a drug commonly used to treat high blood pressure.
The primary goal of our research is to understand how drug metabolism changes across pregnancy. The secondary goal for this research is to define how enzymes in the liver act to up-regulate CYP3A4 during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.
You may be eligible to participate if you:
- Are a woman between the ages of 18 and 45
- Are pregnant, with a Gestational Age < 13 weeks and a singleton pregnancy
- Speak English
- Have hypertension treated with oral extended-release nifedipine
- 3 prenatal extended day study visits
- 1 postpartum extended day study visit
- $30 for the initial screening visit
- $250 for each of the extended day visits
- Free on-site parking
If you are interested in participating or would like to hear more information, please contact our research team at firstname.lastname@example.org or 1-855-99-ASHER.