NEW HAVEN, Conn. (WTNH) — A major clinical study is well underway at Yale School of Medicine and 29 other sites across the country for a life-threatening issue for a pregnant woman and her baby.
Maria Toro has five more days before she delivers her third child, a baby boy. Her high risk pregnancy led to spending 45 days and counting at Yale-New Haven Hospital.
“He is on top of the umbilical cord and putting too much pressure,” she said. “He has a very high chance of him passing away and complications.”
Complications occurred during her last pregnancy as well.
“I was borderline diabetic,” Toro said. “I was also borderline preeclampsia.”
Yearly, up to 5,000 pregnant women in the U.S. can develop preeclampsia, a potentially deadly condition for mother and baby that happens mid-stream.
“There’s a problem with the placenta and how it interacts with the uterus,” said Dr. Michael Paidas, who heads up the Women and Children’s Center for Blood Disorders and Preeclampsia Advancement at Yale School of Medicine.
He is the lead investigator of a nationwide Phase Three clinical trial, focusing on how the FDA-approved drug ATryn can help pregnant women. There is currently no other treatment options than delivering the baby long before the due date.
“We’re hoping it will decrease the inflammation, repair the blood vessels, and decrease clotting to try to reverse this process somewhat so we can gain more time in the pregnancy,” said Dr. Paidas.
The cause is still not certain, but Dr. Paidas says giving the drug intravenously to women with preterm preeclampsia could be key to saving lives and reducing complications.
“Women will come in and will be observed and watched and just wait for things to happen,” he said.
Prolonging pregnancy is the main focus.
“Everyday counts so much for these babies, so even if we can extend it a week and a half or two weeks, that’s a huge difference for the babies,” the doctor said.
Earlier studies on the drug show promising results.
“Most of the very early preterm preeclamptic moms deliver before 28 weeks, or 3 months prior to the due date,” said Dr. Paidas.