Maternal-fetal specialist discovers mountain of rewards in Nepal

By Robin Russell / August 2011

With its stunning Himalayan range, Nepal might bring to mind the daring escapades of Indiana Jones. For one UT Southwestern maternal-fetal specialist, however, the scenic yet impoverished country offers an adventure that focuses not on risking lives, but saving them.

Dr. Jeanne Sheffield, assistant professor of obstetrics and gynecology, will help monitor the safety of pregnant women in rural Nepal who are participating in a flu vaccination program funded by the Bill and Melinda Gates Foundation.

The Field Trial of Maternal Influenza Immunization in Nepal: Mother’s Gift Field Trial (MaGIFT), began in April and will compare the incidence of influenza-like illness episodes and lab-confirmed influenza infection among pregnant women and their newborn infants (through 6 months of age).

Dr. Sheffield, director of the maternal-fetal medicine fellowship, is one of two U.S. researchers selected for a five-person data safety monitoring board. She visited Nepal in March to review the distribution site and the randomization of the study, and to make sure that drugs are stored and refrigerated properly.

“It is very, very different than what we’re used to here, obviously,” she said. “It made me realize how easy it is to run a study here. But the center was very clean and accessible.”

The two-year Nepal study is headed by Dr. Mark Steinhoff, director of the Global Health Center at Cincinnati Children’s Hospital Medical Center, in collaboration with faculty from University of Kathmandu’s Institute of Medicine, Johns Hopkins University’s School of Public Health and Seattle Children’s Hospital, University of Washington.

Dr. Sheffield, a nationally known expert in pandemic flu and pregnancy, already serves on nine data safety monitor boards in the U.S., but says the logistics of running a study in Nepal bring some fairly unique challenges.

Vaccines and supplies are flown into Kathmandu, then delivered in an eight-hour drive by truck over the mountains to the village where the study will take place. The monitoring board members opted instead for a 14-minute flight in an 18-seat airplane.

The village’s local medical center was a structure used in previous studies on nutrition and pregnancy. “There’s a system in place, but it’s scary how limited are resources that we take for granted in the U.S., including electricity and fresh drinking water,” Dr. Sheffield said.

In the Nepal study, about 700 women will be randomized to receive either influenza vaccine or a control during the second or third trimester of their pregnancy. Their infants also will be vaccinated. Study personnel will give the vaccinations at the local center and also will distribute antiviral medications if women do come down with the flu.

Project volunteers recruited and trained from Nepal villages will then visit households each week to observe whether flu-like illness has occurred and to obtain nasal swab specimens for the lab to detect influenza. Swabs will be sent periodically to the University of Washington Virology Laboratory to detect influenza A and B.

“It was wonderful to see the interaction between the Nepali people,” Dr. Sheffield said. “The volunteer women sit down on the floor with them and ask them the questions. It’s very personal. It provides the women with a level of comfort, that their friends and neighbors are doing the interviewing.”

As the monitoring board’s chair, she will review all safety data in a computerized database every three months, then confer annually with other board members. Each data safety monitor has expertise in the area of the study but is completely independent from the study.

“Any changes in the protocol are sent to us to review from a safety standpoint,” Dr. Sheffield said. “We look at any outcomes – if a kid gets a fever or if there’s a possible increase in seizures; we can put a halt to a study. We monitor the safety of the patients themselves.”

Routine immunization of all pregnant women during flu season has been recommended in the U.S. since 1997 and by the World Health Organization since 2005. Flu is present in Nepal for nine to 11 months of the year.

In poorer regions of the world, respiratory infections are among the most common causes of illness and death in both mothers and infants. Of the 10 million deaths in children 5 and under, 4 million die in the first month of life.

“Researchers are always looking at vulnerable populations, and pregnant women are a group that everybody worries about,” Dr. Sheffield said. “The Nepal study will help us learn how easy it is to provide vaccinations to this population.”

She admitted, too, that the trip to Nepal was a personal highlight for someone more accustomed to a research lab and classroom setting.

“I love the whole thought of travel, so I was beyond excited,” Dr. Sheffield said. “My 14-year-old son was very disappointed he couldn’t go. He thought I was going to be climbing mountains.”