Nifedipine Metabolism in Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03654378|
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
|Condition or disease|
|Hypertension Hypertension Pregnancy|
The purpose of this research is to understand changes in a woman's body during pregnancy, specifically how the body processes medication during pregnancy.
The investigators 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 this 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.
The results of this study are expected to have a positive impact, as they will lay a foundation for the design of individualized drug therapy during pregnancy. This foundation will minimize the risk of over- and under-dosing pregnant women.
|Study Type :||Observational|
|Estimated Enrollment :||65 participants|
|Official Title:||Defining Factors Responsible for Temporal Changes in CYP3A4-Mediated Drug Metabolism During Pregnancy|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
- Change in concentration-to-dose ratio of Nifedipine in plasma [ Time Frame: Between 2-16 weeks, 17-26 weeks, 27-39 weeks and 3 months postpartum. ]
- Change in thyroid hormone levels in plasma [ Time Frame: Between 2-16 weeks, 17-26 weeks, 27-39 weeks and 3 months postpartum. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654378
|Contact: Minaz K Cattan, M.D.||email@example.com|
|Contact: Gabrielle Mesches, M.S.||firstname.lastname@example.org|
|United States, Illinois|
|Northwestern University Asher Center for the Study and Treatment of Depressive Disorders||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Minaz K Cattan, M.D. 312-695-7190 email@example.com|
|Contact: Gabrielle A Mesches, M.S. 312-695-6684 firstname.lastname@example.org|
|Principal Investigator: Katherine L Wisner, M.D., M.S.|
|Principal Investigator:||Katherine L Wisner, M.D., M.S.||Northwestern University|
|Principal Investigator:||Hyunyoung Jeong, PharmD, PhD||University of Illinois at Chicago|