Major breakthrough in preventing premature birth announced by NIH/WSU

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 19th and 24th weeks of pregnancy. Pregnant women with a short cervix (one that is < 20mm) are at very high risk for preterm delivery.

Dr. Romero added that, once a high-risk mother for preterm delivery has been identified, she can be offered treatment with progesterone. Of major interest is that progesterone reduced the risk of preterm delivery not only at < 33 weeks, but also at < 28 weeks (one of the secondary endpoints of the study). It also reduced the rate of respiratory distress syndrome, the most common complication of premature babies.

"We believe that the data in our study speaks for itself – and we predict that it will have major implications for obstetrics."

"The findings of the study are especially good news for expectant mothers in Detroit," said Dr. Hassan. "Preterm delivery has long been a major healthcare problem in the city." In 2008, more than 17 percent of births Detroit were preterm – and they accounted for more than 70 percent of the infant mortality recorded in that year, according to the latest research from the Michigan Chapter of the March of Dimes.