Trial to Test Promising Drug for Severe Nausea During Pregnancy

Thomas J. Guttuso Jr., MD

Thomas J. Guttuso Jr., MD, aims to find the first clinically meaningful therapy for a disease that causes debilitating symptoms in pregnant women.

Published May 19, 2014

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.

“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.”
Thomas J. Guttuso Jr., MD
Associate professor of neurology and obstetrics and gynecology

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.

Two-Arm Study To Test Gabapentin, Ondansetron

Through Guttuso’s randomized, double-blind 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 post-shingles 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-to-severe 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.

Daily Diary Scores Measure Success

To evaluate efficacy and tolerability, the researchers will look primarily at daily Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scores. Other measures of effectiveness will include maternal and fetal outcomes as well as patients’:

  • oral nutrition, or nutrients taken by mouth versus intravenously
  • quality of life
  • overall level of satisfaction or dissatisfaction with the medication
  • blood laboratory values
  • need for IV hydration or hospital admission

Prior Results Show Dramatic Improvements

Guttuso led a pilot study involving seven hyperemesis gravidarum patients, published in Early Human Development in January 2010. After two weeks of gabapentin therapy, patients’ nausea decreased by an average of 80 percent and vomiting decreased by 94 percent.

The research team also included Luther K. Robinson, MD, professor of pediatrics.

Guttuso’s prior research also has linked gabapentin with marked reductions in refractory nausea and vomiting in other patient populations.

Research Gives Women ‘Renewed Sense of Hope’

The importance of Guttuso’s research to women facing hyperemesis gravidarum is reflected in a Facebook group that provides information about the use of gabapentin during pregnancy.

According to one of the group’s administrators, about 100 people have joined so far. “These women who thought they would never be able to have another child are being given a renewed sense of hope,” she wrote in a message to Guttuso.