Trial to Test Promising
Drug for Severe Nausea
During Pregnancy
Thomas J. Guttuso Jr., MD, aims to find the first clinically meaningful
therapy for a disease that causes debilitating symptoms in pregnant
women.
Building on a successful pilot
study, Thomas J. Guttuso Jr., MD,
associate professor
of neurology and obstetrics and
gynecology, will test the effectiveness of
the anticonvulsant drug gabapentin in
treating hyperemesis gravidarum, a rare
but disabling condition of early
pregnancy.
His study could lead to the first clinically
meaningful therapy for the disease,
which causes severe nausea, vomiting
and anorexia, and leads to dehydration,
weight loss, hospitalization and
significantly reduced work time.
“Symptoms can be so devastating that
about 15 percent of patients choose to
end their pregnancies, primarily because
they see no hope for relief or they feel
they are unable to care for themselves or
their families,” says Guttuso.
His four-year clinical trial will be funded
with a $1.3 million grant from the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development.
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Two-Arm Study To Test
Gabapentin, Ondansetron
Through Guttuso’s randomized, doubleblind trial, half of the expected 80
participants will be treated with
gabapentin and the other half with
ondansetron, for two weeks.
Gabapentin is used to help control
certain types of seizures as well as postshingles nerve pain and restless legs
syndrome.
Ondansetron, a serotonin 5-HT3 receptor
antagonist, is used to prevent nausea
and vomiting caused by cancer
chemotherapy, radiation therapy and
surgery.
All participants will have moderate-tosevere refractory nausea and vomiting
within the first 16 weeks of pregnancy.
As a result, they will have lost more than
5 percent of their body weight.
The trial will take place at the University
at Buffalo and the University of
Rochester.
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