An ongoing Phase III clinical trial for a drug to treat preeclampsia in pregnant women enrolled its first patient at UAB. A successful outcome using this drug could be a significant step toward reduction of pre-term births and infant mortality which have increased significantly over the past 20 years.
Preeclampsia affects about five percent of pregnant women and often presents early in pregnancy with elevated blood pressure and kidney abnormalities, among other symptoms. The condition can have serious and often fatal implications for both mother and baby.
“It is one of the major causes of death and disability for the pregnant woman and her offspring. The cause is unknown, but it is thought to occur because of certain changes in the placenta,” says Alan Tita, MD, PhD, professor of Obstetrics and Gynecology in UAB’s School of Medicine and a lead investigator for the trial. “The number of cases is increasing because of increasing frequency of risk factors that include older maternal age, obesity, first pregnancies in older women, prior preeclampsia, twin pregnancies and medical conditions such as diabetes and chronic hypertension.”
Currently, the only treatment that can reverse preeclampsia is delivery of the baby, but Tita is hopeful that the Federal Drug Administration (FDA) approved medicine ATryn® - an antithrombin recombinant – being tested in the PRESERVE-1 trial will prolong pregnancy in mothers with early-onset preeclampsia and reduce the high rates of perinatal mortality and disability it causes. The medicine is already being used for the prevention of blood clots in pregnant women and surgical patients who have a natural inability to produce enough of their own antithrombin, but the safety and effectiveness of the drug in early-onset preeclampsia has not been studied.
“ATryn® is already approved for use in pregnant and non-pregnant populations for other reasons and has anti-inflammatory and blood-thinning capabilities that may work against some of the mechanics that we think are involved in preeclampsia.” Tita says. “Based on preliminary studies, there is promising information to support this study.”
Preeclampsia can typically occur anytime between 20 weeks of pregnancy and full-term at 40 to 41 weeks. Those who develop the condition early, develop it prior to 34 weeks. The PRESERVE-1 study will test the safety and efficacy of antithrombin in women with preeclampsia that occurs between 23 and 30 weeks of pregnancy, because early-onset of the condition is the most serious form.
“We are enrolling women who develop preeclampsia prior to 30 weeks, because that defines a high-risk population that is likely to have severe outcomes for both mother and baby,” Tita says. “If we are able to show a benefit to this group through the trial, we then could mount another study for those patients who develop the condition later in pregnancy.”
UAB is among many medical centers participating in the trial, Tita says, and continues to enroll the largest number of participants in the study because of the high-risk population served statewide, referrals from primary providers and the dedication of the clinical and research teams. He encourages Alabama healthcare providers with patients who may have early onset preeclampsia to contact study investigators. “We are happy to offer the opportunity for eligible patients to participate in this trial,” he says. “They can contact the Maternal/Fetal Medicine (MFM) physician on call at UAB to arrange medical transfer and to discuss the possibility of participation in the study. The MFM provider on call will alert the study team.”
Tita hopes this trial will demonstrate that the medication will prolong pregnancy and lead to improvements in pregnancy outcomes for the baby. “If it is a positive trial, that means we will have been able to prolong pregnancy,” he says. “And when you prolong pregnancy, you also increase gestational age which likely leads to an improvement in the ultimate outcomes for the babies born to women with early-onset preeclampsia.”