| THURSDAY, Feb. 6 (HealthScoutNews) -- In what they describe as a notable first, researchers today report the successful test of a treatment to reduce the incidence of premature births in high-risk women.
Injections of 17-alpha-hydroxprogesterone caproate (17P), a derivative of the hormone progesterone, reduced premature births by more than a third in a group of women at high risk because they had borne preemies before, Dr. Paul J. Meis, a professor of obstetrics and gynecology at Wake Forest University Baptist Medical Center, told the annual meeting of the Society for Fetal-Maternal Medicine in San Francisco.
"The evidence of this treatment's effectiveness was so dramatic, the research was stopped early," Meis says in a statement released before the presentation. "This drug is readily available and can be used by doctors to improve outcomes for mothers and babies."
"This report is being greeted with remarkable enthusiasm by clinicians, who tend to be reserved," says Dr. Nancy S. Green, medical director of the March of Dimes Birth Defects Foundation, which has just launched a major campaign to reduce premature births. Results of the study were eagerly awaited, she says.
Studies have shown that prematurity, defined as delivery before the 37th week of gestation, is associated with learning and developmental difficulties. In 2000, 11.9 percent of babies were born prematurely in the United States, and the government's Healthy People program has a goal of reducing that to 7.6 percent by 2010.
The study reported by Meis was done in the 19 centers belonging to the government-funded Maternal Fetal Medicine Units Network. All the women in the study had a history of premature birth, a major risk factor for another premature birth. Some were given weekly injections of 17P, starting at the 16th to 18th week of pregnancy; the others got placebo injections.
The intention was to enroll 500 women in the study. Only 463 were enrolled when it was found the 17P injections reduced birth before the 37th week by 34 percent and the incidence of birth before 32 weeks by 42 percent.
"This is the first well-documented demonstration of a successful treatment to reduce pre-term births in women at risk," says the Meis statement.
This study was undertaken because the researchers remembered several small-scale studies done in the 1960s and 1970s in which 17P showed promise, Meis says in an interview.
"After that, for no good reason it just fell into inattention," he says. The existence of the fetal medicine units network, which performs over 80,000 deliveries a year, made the study possible, he says.
The mechanism by which 17P acts remains uncertain, Meis says. One theory is that it quiets the muscular activity of the uterus.
"This is a tangible example of research not only promising but also delivering," Green says.
It's too early to say whether the 17P treatment could help women at high risk because of other factors, such as having had a Caesarean section, obesity or being black, she says. Black women are at higher risk for no known reason, Green says. In the study, the 17P treatment was effective in all ethnic groups.
The group that did the 17P study will move on to another study that includes both the hormone and omega-3 fatty acids. Eating fish, which are rich in those fatty acids, has been found to be associated with a decreased risk of prematurity, and soon the acids themselves will be tested as a treatment.
You can learn more about premature birth from the March of Dimes Birth Defects Foundation or the National Institute of Child Health and Human Development.
SOURCES: Nancy S. Green, M.D., medical director, March of Dimes Birth Defects Foundation, White Plains, N.Y.; Paul J. Meis, M.D., professor of obstetrics and gynecology. Wake Forest University Baptist Medical Center, Winston-Salem, N.C.; Feb. 6, 2003, annual meeting, Society for Fetal-Maternal Medicine, San Francisco; Wake Forest University news release
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