28 Aug OB/GYN opens MFM Clinical Trials Aimed at Improving Preeclampsia Care
Dr. Anna Palatnik and the Department of Obstetrics and Gynecology is excited to announce our participation in two new multicenter clinical trials aimed at improving the care of women who develop preeclampsia during pregnancy.
Preeclampsia is a complication of pregnancy that causes high blood pressure and poor kidney function. In severe cases, women with preeclampsia may have seizures, organ failure, or die. Beyond managing symptoms, very little is known about how to treat preeclampsia – the only known “cure” is birth of the baby, even if the baby is not yet fully-developed. Babies born to mothers with preeclampsia are at increased risk for infection, breathing problems, developmental disorders, bowel problems, brain damage, or even death, especially when they are delivered early.
The first trial, sponsored by a diagnostic testing company called Progenity, is focused on developing a test to predict a woman’s risk of developing preeclampsia during her pregnancy. To do this, the study will enroll patients who receive testing to rule out preeclampsia as a cause of their high blood pressure (or other symptoms they are experiencing). The study will collect samples from all women who enroll – regardless of whether or not they actually develop preeclampsia – up to every two weeks until delivery. These samples will be used to confirm the accuracy of a test that may be able to determine a woman’s risk for developing preeclampsia.
The second trial, sponsored by Velo Bio, aims to find out whether treating severe preeclampsia with a medication called Digoxin Immune Fab helps to reduce serious complications for mothers with severe preeclampsia and their babies. Digoxin Immune Fab is a medication FDA-approved for use in treating Digoxin overdose, and is being investigated in this study because some previous studies have found high levels of “digoxin-like factors” in the blood of women with preeclampsia. Since the risk of prematurity-related complications is greatest earlier in pregnancy, only women less than 32 weeks gestation will participate in the study. The study will monitor both mothers and babies for complications for the remainder of the pregnancy and postpartum period and will determine if Digoxin Immune Fab helped improve outcomes for both mothers and babies.
- American College of Obstetricians and Gynecologists’s Frequently Asked Questions on preeclampsia and high blood pressure
- Preeclampsia Foundation.
To learn more about the preeclampsia trials at Froedtert and MCW, please visit the Progenity PRO-104-Preeclampsia clinical trials website and the Velo-201 clinical trials website.
10 million women develop preeclampsia world-wide each year , with 5-8% of all US births impacted by preeclampsia and other related hypertensive disorders. We are excited for the opportunity to help improve global maternal and infant health through preeclampsia research!