New study attempts to tackle preeclampsia which disproportionately affects Black pregnancies
9th November 2015 · 0 Comments
By Ryan Whirty
Contributing Writer
Pregnancy disorders preeclampsia and early-onset preeclampsia affect roughly 10,000 women in the United States each year. That might not seem like a lot, but when the condition is potentially fatal to both the baby and the mother, it becomes deadly serious.
What’s more, the disorder is growing rapidly in frequency — according to the American Journal of Perinatology, the occurrence of preeclampsia and early-onset preeclampsia has increased by 67 percent and 140 percent, respectively, over the last two decades.
But there’s still more. The two conditions appear disproportionately within the African-American community; roughly one in six lives births by African-American women feature a diagnosis of preeclampsia.
However, the women of New Orleans will get a unique opportunity to help develop a new treatment of the potentially fatal pregnancy complication when rEVO Biologics, a commercial-stage biopharmaceutical company, conducts its on-going study, PRESERVE-1, a landmark clinical trial evaluating and testing the safety and efficacy of a potential cutting-edge new treatment for preeclampsia in women between the 23rd and 20th weeks of pregnancy.
The rEVO company and its parent corporation, the France-based LFB Group, are currently recruiting women in the New Orleans area to participate in the on-going efforts of PRESERVE-1, and Dr. Michael Paidas, the senior author of the LFB-funded study in the American Journal of Perinatology and PRESERVE-1, said there’s a significant reason why the conductors of the undertaking are targeting the NOLA area and its residents.
“We found that there are areas of the country where preeclampsia occurs at a greater rate,” Paidas said. “States in the South have an almost disproportionate rate of occurrence. That’s one reason we wanted to focus on the New Orleans area.”
But what is preeclampsia? The perinatal complication typically develops after the 20th week of pregnancy, while early-onset preeclampsia is a severe form of the disorder that presents itself before the 34th week of gestation.
The complication is characterized by high blood pressure and is believe to result from an abnormal interaction between the mother’s cardiovascular and immune systems, according to a rEVO press release. As of now, the only conclusive treatment for the disorder is delivery of the newborn regardless of gestational age.
“Mothers with preeclampsia account for approximately 10 percent of births before 34 weeks gestation,” stated the press release. “Preterm infants, particularly those born at or before 28 weeks, have a greater likelihood of cardiovascular and respiratory diseases ,as well as higher rates of disability, cognitive delays and behavioral or psychological effects.”
Preeclampsia is among the top six causes of maternal mortality in the United States, and it is also associated with infant death and complications for the mother and newborn for a lifetime. Mothers showing preeclampsia have lower levels of a recombinant protein that is crucial to the delivery of a healthy baby.
“Preterm infants, particularly those born at or before 28 weeks, have a greater likelihood of cardiovascular and respiratory diseases as well as higher rates of disability, cognitive delays and behavioral or psychological effects,” stated the rEVO press release.
Paidas said the disproportionate rates of preeclampsia within the African-American community — the study found that roughly one in six live births by African-American women are affected — potentially result from an increased occurrence of several of the risk factors for the condition, such as general health, lifestyle and amount of physical activity of the mother, as well as socioeconomic status.
But Paidas — who serves as professor and vice chairman of obstetrics and director of the Yale Women and Children’s Center for Blood Disorders and Preeclampsia Advancement in the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine — said much more study is needed, which is why he, as well as his study co-authors and the rEVO company, is continuing to conduct the PRESERVE-1 study.
“We don’t really have good data from pre-term pregnancies,” he said. “That’s why we embarked on this study. It was a several-year process to get to this point. We have offices at 30 sites in the country, and we’re at the most important stage of the trial right now.”
Paidas said the ultimate goal of the PRESERVE-1 study is to extend the length of pregnancy within mothers affected by preeclampsia. He said if the conductors of the study can do that, the results of PRESERVE-1 could be landmark.
“Every day [of gestation] counts,” he said. “Every day we can gain increases the likelihood of a healthy delivery.
“This is one of the most pressing [perinatal] problems we have right now,” he added. “The potential for development a treatment with these trials would have a huge effect on the mother and the baby.”
Women in the New Orleans area interested in participating in the PRESERVE-1 study should contact Christine Servay at Ochsner Baptist Hospital at (504) 894-3039 or cservay@ochsner.org.
This article originally published in the November 9, 2015 print edition of The Louisiana Weekly newspaper.
