Nonprofit funds research to test for pregnancy complication ICP

A nonprofit group has donated $60,000 to support researchers at Yale University School of Medicine working to expand access to a new test that can be used to rapidly diagnose and monitor intrahepatic cholestasis of pregnancy (ICP).

The grant from Judd’s Legacy “will allow us to demonstrate the utility of this relatively newly implemented assay so that more clinicians can adopt it and more hospitals can recognize its value,” Joe El-Khoury, PhD, associate professor of laboratory medicine at Yale and the project’s leader, said in a university press release.

“For a small subset of patients, it may be the difference between life and death of their baby,” El-Khoury said.

ICP is a rare pregnancy complication in which bile, a digestive fluid made in the liver, isn’t able to flow properly into the intestines, so it builds up in the liver and leaks into the bloodstream. It typically occurs during the third trimester of pregnancy, when there is an increase in the production of pregnancy hormones that can also affect bile flow.

High bile acid levels in the blood can cause serious pregnancy complications, including stillbirth, so it’s crucial to monitor their levels in people with ICP.

Testing delays for rare pregnancy complication can have dire consequences

At most hospitals, this is done by taking a blood sample and shipping it to a laboratory, where a complex chemical analysis technique called mass spectrometry is used to assess levels of specific bile acids. This process usually takes a few days, sometimes as long as a week. But delays can have devastating consequences.

That’s what happened to Allison Gardner, founder and president of Judd’s Legacy, in October 2018. She developed ICP while pregnant with a baby, whom she and her husband had named Judd William.

While awaiting results from a bile acid test, Gardner noticed the baby had stopped moving. She and her husband rushed to the hospital, where doctors confirmed that Judd had died in the womb.

Gardner started Judd’s Legacy with the goal of raising ICP awareness, promoting more rapid testing, and supporting research into better diagnostics.

“I knew that there was something that needed to change, because there are so many unknowns” with ICP, Gardner said. “All of those unknowns are why we lost our baby.”

ICP can be overlooked by healthcare providers, as it was initially by Gardner’s obstetrician in South Carolina. Gardner had complained of itching, the most common symptom of IPC, during her third trimester, and her doctor suggested she try an over-the-counter antihistamine. Itching can occur as a manifestation of pregnancy due to hormonal changes or skin stretching.

“I wanted my child to leave a legacy and make a difference here on earth since he didn’t get the opportunity,” Gardner said. “We hope Judd’s passing brings about some good to save other babies and to prevent other families from going through the same heartache our family has experienced.”

Results on par with gold standard in less time

The newly funded Yale project aims to demonstrate the utility of a relatively new diagnostic test called total bile acids, or TBA, to diagnose and monitor ICP. According to El-Khoury, the test can return results on par with those from the gold-standard mass spectrometry in about an hour using standard automated equipment that’s available at hospitals.

El-Khoury’s lab has been using the TBA test, which has been approved for use by the U.S. Food and Drug Administration, since 2019.

“I can tell you that clinicians at Yale have been thrilled with the tests since we started using it,” El-Khoury said, but “to this day many labs don’t know about it or use it.”

Gardner has worked to bring TBA testing to hospitals in her home state. Her efforts helped establish the first in-house bile acid lab in the state, which began testing, with results in three hours, in late 2021. Now, with funding raised by donations, sponsorships, and an annual 5K run, she is hoping to spur research to get the TBA test more widely used.

“Without research, the protocol of ICP treatment and diagnosis isn’t going to change,” Gardner said.

El-Khoury said he wants labs “to know there is an alternative test out there that gives results within an hour and is just as useful as mass spectrometry.”

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