A groundbreaking clinical study of a new method for preventing premature birth in millions of women each year, published in the medical journal Ultrasound in Obstetrics & Gynecology, shows that the rate of early preterm delivery in women (< 33 weeks) can be reduced by 45 percent simply by treating pregnant women at risk with a low-cost gel of natural progesterone during the midtrimester of pregnancy until term.
The peer-reviewed findings were led by the Perinatology Research Branch of the National Institutes of Health, housed by the Wayne State University School of Medicine at Hutzel Hospital in Detroit. The findings are certain to have substantial impact on the practice of medicine, according to the principal investigator of the three-year clinical trial.
The study is entitled Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.
"The study published today offers hope to women, families and children," said Dr. Roberto Romero, Chief of the Perinatology Research Branch of the NIH. "Worldwide, more than 12 million premature babies 500,000 of them in this country are born each year, and the results are often tragic. Our clinical study clearly shows that it is possible to identify women at risk and reduce the rate of preterm delivery by nearly half, simply by treating women who have a short cervix with a natural hormone - progesterone."
Dr. Romero, principal investigator of the study, and Sonia S. Hassan, M.D., the lead author of the study and associate professor of obstetrics and gynecology in the WSU School of Medicine, also pointed out that numerous studies (many by the PRB) over the past decade have shown that ultrasound of the uterine cervix can identify pregnant women who are at high risk for preterm delivery. The ultrasound examination is simple to perform, painless, and can be performed between the 19
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Wayne State University - Office of the Vice President for Research