A groundbreaking clinical study of a new method for preventing premature birth in millions of women each year shows that the rate of early preterm delivery in women — less than 33 weeks’ gestation — 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, hosted by Wayne State University at Detroit Medical Center’s Hutzel Women’s Hospital. 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, hief 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 the Director of the PRB’s Center for Advanced Obstetrical Care and Research housed at the DMC/WSU campus, also pointed out that numerous studies 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 less than 33 weeks, but also at less than 28 weeks. It also reduced the rate of respiratory distress syndrome, the most common complication of premature babies.
“The findings of the study are especially good news for expectant mothers in Detroit,” Hassan said. “Preterm delivery has long been a major healthcare problem in the city.”
In 2008, more than 17 percent of births in 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.
The city’s high infant mortality, preterm delivery rate and ethnic disparity in birth outcomes were important considerations in the NIH’s decision to establish the PRB in Detroit nine years ago. The presence of the PRB in Detroit allows women to obtain state-of-the-art medical care and join medical studies to improve prenatal diagnosis, monitor fetal growth, predict preeclampsia and prevent preterm birth.
The study was conducted at 44 centers worldwide and co-sponsored by the PRB, in collaboration with Columbia Laboratories Inc., at DMC Hutzel Women’s Hospital and Wayne State University during the past three years. The study included patients from the United States, South America, Europe, Asia and Africa, and screened more than 32,000 women for a short cervix.
Describing the startling results, which showed that the rate of preterm birth among the women with a short cervix had been reduced by 45 percent, Dr. Hassan — Director of the PRB/DMC/Wayne State University Maternal-Fetal Medicine Fellowship Program — noted in the study: “The main implication for clinical practice is that universal screening of women with ultrasound examination in the midtrimester to identify patients at risk (based on a short cervix) can now be coupled with an intervention — the administration of vaginal progesterone gel — to reduce the frequency of preterm birth and improve neonatal outcome. This can be accomplished conveniently.”
“We’re obviously very gratified by these results,” said Hassan. “Based on the findings of our clinical trial, we expect that obstetricians and clinicians will begin to consider providing expectant mothers with ultrasound screening for cervical length, and to make progesterone therapy available to those who present with a short cervix. Our group has been working on this approach to reducing infant mortality for much of the past decade, and it’s very exciting to see that the effort is paying off, and that mothers and infants will soon be able to benefit from it.”
DMC President and CEO Michael Duggan noted that the successful clinical trial is one of a series of successful research initiatives to have been undertaken at the nine-hospital medical complex in mid-town Detroit in recent years.
“The DMC has a long record of pioneering innovation in heart surgery, AIDS therapy, stroke and cardiac care and several other areas of medical treatment,” he said. “Given that outstanding record, it’s no surprise to learn that we are once again participating — this time with Dr. Roberto Romero, the PRB and Wayne State — in a medical breakthrough of international importance. We’re proud to be part of a research effort that has the potential to free millions of women and infants from the scourge of premature birth.”
Duggan went on to suggest that the PRB’s headline-making discovery seems “especially poignant,” since it took place in Detroit, where infant-mortality rates have traditionally been high and one birth out of every six is premature, on average.
Kai Paul, a 29-year-old nursing student and Detroit resident who was part of the clinical trial, said that she was able to deliver a “very healthy baby boy” – in spite of having been identified about 18 months ago as “at a very high risk for preterm delivery.”
“I had an ultrasound scan at Hutzel back in November of 2009, and the results showed that I had an extremely short cervix,” Paul said. “That put me at high risk for preterm delivery, and the doctors told me I had a 50-50 chance of a preterm delivery. I was very upset about that — I was crying, scared and very depressed. But then I spoke with two Hutzel Hospital nurses who were enrolling expectant mothers in the progesterone trial. They worked with me, and they explained that the daily progesterone might help to prevent premature delivery. And they were right! I call those nurses ‘my two angels’ — because they helped me through the process, and today I have a beautiful, one-year-old son.”
The baby was born at eight and half months, within the “normal range” of delivery.
“I’m a nursing student, and I love to learn about science and medicine,” Paul said. “I already knew about the value of clinical trials in medicine … but now I can actually feel the power of medical research, every time I look at my baby boy!”