For years, Detroit has been known to have a high rate of premature birth and infant mortality.
To address these important problems, Dr. Roberto Romero and Dr. Sonia Hassan, along with a team of brilliant researchers, conducted a groundbreaking study as part of the Perinatology Research Branch of the National Institute of Child Health and Human Development of the National Institutes of Health on the campus of the Detroit Medical Center at DMC Hutzel Women’s Hospital and Wayne State University.
On Wednesday, April 6, 2011, the world learned the results of a groundbreaking clinical study of a new method for preventing premature birth in millions of women each year. Published in the authoritative Ultrasound in Obstetrics & Gynecology, the study 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 for preterm delivery with a low-cost natural progesterone “gel” during the midtrimester of pregnancy until term. This breakthrough will become a care protocol for all applicable DMC patients.
The study is entitled Vaginal progesterone reduced 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 (PRB) 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."
DMC Specialists Leading the Research
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 (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. It also reduced the rate of respiratory distress syndrome, the most common complication of premature babies.
||Meet the Doctors
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Roberto Romero, M.D. is Chief of the Perinatology Research Branch and Program Director for Perinatal Research and Obstetrics in the Division of Intramural Research of NICHD/NIH. He also holds academic appointments as Professor of Molecular Obstetrics and Genetics at Wayne State University and Professor of Epidemiology at Michigan State University.
Dr. Romero trained at Yale University in Obstetrics and Gynecology and in the sub-specialty of Maternal-Fetal Medicine. Subsequently, he joined the faculty and became the Director of Perinatal Research. In 1992, he became Professor and Vice Chairman of the Department of Obstetrics and Gynecology at Wayne State University and Chief of the Perinatology Research Branch of NICHD/NIH. Click here for more information
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Sonia S. Hassan, M.D. is the Director of the Detroit Medical Center (DMC) /Perinatology Research Branch/Wayne State University (WSU) Maternal-Fetal Medicine Fellowship and the Associate Director of the Combined Maternal-Fetal Medicine/Medical Genetics Fellowship. She is also an Associate Professor in the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, at WSU and the DMC, and Director of the Center for Advanced Obstetrical Care and Research in the Perinatology Research Branch of the National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), of the US Department of Health and Human Services (DHHS). Click here for more information
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"We believe that the data in our study speaks for itself -- and we predict that it will have major implications for obstetrics.”
Saving at-Risk Babies in Detroit
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 the 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 safely and conveniently.”
“We’re obviously very gratified by these results,” said Dr. 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.”
A Long Record of Healthcare Innovation
The successful clinical trial is one of a series of successful research initiatives 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.
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.
"As a research university, Wayne State's mission is to discover and apply knowledge that contributes to the positive development and well-being of society," said Valerie M. Parisi, M.D., M.P.H., M.B.A., Dean of the WSU School of Medicine. "Today's findings are an example of research that is quickly translated into improved clinical care outcomes. Wayne State will aggressively share this new knowledge with health care providers here in Detroit, in Michigan and around the world so that it can benefit pregnant women. I'm confident that the strong partnership between the PRB, the DMC and Wayne State will continue to result in pioneering contributions for pregnant women and unborn children."
Thomas A. Malone, M.D., President of DMC Hutzel Women’s Hospital, said "this successful clinical trial is exactly why the DMC, WSU and the NIH partnered to locate the PRB at Hutzel Hospital. I believe this is just the first of many breakthroughs to come from this partnership."
Saving Chase: A Success Story
One-year-old “Miracle Baby” is thriving after new progesterone therapy results in normal delivery at DMC Hutzel Women’s Hospital
When 28-year-old Kai Paul learned that she was pregnant, back in the summer of 2009, she was “absolutely thrilled” to hear the news.
“For me, it was a dream come true,” says the Detroit nursing student today. “I felt so grateful, so joyful . . . and I could hardly wait for the arrival of my baby.”
But then Kai got some bad news.
During an ultrasound examination conducted at DMC Hutzel Women’s Hospital in November of ’09, Ms. Paul learned that she was at “very high risk” for giving birth prematurely.
A usually cheerful and high-spirited young woman who was looking forward to her new life as a mom, Kai was devastated to learn that her pregnancy might be in trouble.
“I was extremely upset, as you might imagine,” she recalls today. “I was crying, and scared, and very depressed. It was a difficult time for me, and I really don’t know how I got through it.”
Kai’s anxiety was easy to understand. Like hundreds of other expectant mothers in Detroit each year, she was suddenly facing a terrible dilemma.
Because the ultrasound procedure at Hutzel had determined that she had a condition called a “short cervix,” Kai now confronted a greatly elevated risk of delivering her baby too soon.
According to the latest medical research, a “short cervix” increases the risk of a preterm delivery dramatically. For example, a cervix that is <15mm is associated with a 50%
higher risk of preterm delivery before 32 weeks (early preterm birth).
In Detroit, where premature birth and often-related infant mortality have long been chronic public health problems, the association between the cervical abnormality and a high risk of delivering early is a well-documented medical fact.
In 2008, for example, more than 17 percent of the babies born in the city were preterm, according to statistics of the Michigan Chapter of the March of Dimes.
As the weeks passed and Ms. Paul spent endless days flat on her back (“I’d been told that ‘getting plenty of bed rest’ was the only available therapy, up to that point”), she sank into a deep, gloomy depression.
But then she finally caught a break.
“During one of my visits to Hutzel,” she remembers, “I spoke with two nurses who were enrolling expectant mothers in a new progesterone [clinical] trial. They worked with me, and they explained that the daily progesterone [prescribed for patients in the trial] 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.
“I call him my ‘miracle baby,’ and it’s a joy to watch him growing up now and getting into everything.”
For DMC-Based Researchers, A “Very Gratifying Outcome”
The three-year, international medical trial was conducted by the NIH’s Perinatology Research Branch (PRB) –a collaboration between the PRB, at DMC Hutzel Women’s Hospital and Wayne State University (WSU) and other centers worldwide. The study was designed to find out if women at high risk for preterm delivery could be protected from it by the natural female hormone progesterone.
During the last third of her pregnancy, Ms. Paul received daily doses of the low-cost medication in the form of a vaginal gel that was easy to absorb and left her with no side effects.
“As a participant in the clinical trial, Ms. Paul was carefully monitored,” said Sonia S. Hassan, M.D., the lead author of the clinical study and Director of the PRB’s Center for Advanced Obstetrical Care and Research housed at the DMC/Wayne State University (WSU) campus, where Ms. Paul participated in the study and received regular obstetrical exams and treatment.
Added Dr. Hassan: “One of the best things about our Center is that we can bring the
latest, state-of-the-art medical care to expectant mothers in Detroit, while conducting cutting-edge medical research.”
The results were heartening, to say the least. Ms. Paul’s son, Chase Paul, was born normally on February 27th, 2010 – and is, by her description, “a very healthy and very active one-year-old.”
The baby was born at almost thirty-nine weeks, easily within the normal range of delivery.
Reflecting on that happy outcome, Dr. Roberto Romero – a primary investigator of the successful clinical trial that helped bring Kai’s baby safely into the world – said it was a “compelling example of how this new therapy will be able to help many expectant mothers at risk for preterm delivery.”
“The clinical study we just published [in the authoritative medical journal Ultrasound in Obstetrics & Gynecology] offers new hope to women everywhere,” said Dr. Romero. “Worldwide, more than 12 million expectant mothers – 500,000 of them in this country – give birth prematurely each year, and the results are often tragic. But the results of our three-year, international clinical trial show clearly that it’s possible to reduce the incidence of preterm delivery by half . . . simply by treating women who have been identified as at risk for the condition with an easy-to-assimilate form of the female hormone progesterone.
“The study in Ultrasound in Obstetrics and Gynecology documents the effect of progesterone therapy in women who are likely to deliver prematurely,” added Dr. Romero. “And when you see how it can help an expectant mother to avoid the problems often associated with preterm delivery, that’s very gratifying indeed.”
So how are Kai Paul and baby Chase doing these days?
“We’re both doing great!” says Ms. Paul, who has a degree in psychology from Wayne State University and is now working on a second degree in nursing. “As a nurse, I love to learn about science and medicine. I already knew about the value of clinical trials . . . but now I can feel the power of medical research, every time I look at my baby boy.”
At Risk For Preterm Birth, Detroit Mom Delivered Healthy Baby –
Thanks To DMC Progesterone Trial
Normal delivery of “Baby Robert” followed several months of taking female hormone as an easy-to-absorb vaginal gel
Laura Delaney-Adams says she will never forget the moment when the obstetrician told her that her pregnancy might be in trouble.
“It happened on the 22nd of September, 2009,” says the Detroit Licensed Practical Nurse (LPN). “I still remember the date – it was two days before my 21st birthday – and I still remember the concern I felt when I learned that had a shortened cervix.”
On that unforgettable afternoon at DMC Hutzel Women’s Hospital, Ms. Delaney-Adams underwent an ultrasound test and discovered that she had developed a risk factor for preterm birth.
The presence of a short cervix meant that she was at “very high risk” for premature delivery of her baby, which was due in about three months.
Suddenly, this normally cheerful and easygoing practical nurse was facing a major health threat.
In Detroit, where premature birth and often-related infant mortality have long been urgent public health issues, the association between the cervical abnormality and a high risk of delivering early has long been an established medical fact.
“I was pretty worried at first,” says Laura today, while describing that difficult moment at Hutzel 18 months ago. “I also felt pretty frustrated. But I’m a fighter, and I didn’t really get down or depressed.
“Instead, I started asking myself: what can I do to take care of this? What steps can I take to make my situation better?”
It was a difficult problem, says Laura – but her luck began to change a few days later, after she learned about a clinical trial that was taking place at Hutzel under the direction of the NIH Perinatology Research Branch (PRB), at the Detroit Medical Center and Wayne State University campus.
The clinical study had been designed to test the effectiveness of the female hormone progesterone in helping expectant mothers with a shortened cervix to avoid giving birth prematurely.
As a trained LPN who has also studied physical therapy, Ms. Delaney-Adams knew about the hazards that can accompany preterm birth. She also knew that the problem was widespread in the Motor City. In 2008, for example, more than 17 percent of the babies born in Detroit were preterm, according to statistics of the Michigan Chapter of the March of Dimes.
Laura’s situation was uncertain and troubling, for sure. At this point, she could only hope that the gel she was taking as part of the clinical study would allow her to escape the consequences of preterm birth.
“The doctors and nurses had warned me that with a short cervix, I ran a high risk of having a premature baby,” she recalls today. “But the gel was designed to help prevent that, and I was eager to be part of the study. It was easy to take, and I soon got used to the daily routine.”
During the last two months of her pregnancy, Laura was often holding her breath. But with each new day – as the danger of early delivery slowly faded – she grew more hopeful.
And then, on the 2nd of January, 2010, her story took a joyful turn . . . when she gave birth to a healthy baby boy, her brand-new son, Robert.
The infant was born only a few days before the nine-month mark, and well within the “normal” time-frame for healthy delivery. He weighed six pounds, 17 ounces, and his birth was problem-free.
For the clinicians who had monitored her pregnancy and her participation in the clinical trial, the outcome was highly encouraging.
“As a participant in the clinical trial, Ms. Paul was carefully monitored,” said Sonia S. Hassan, M.D., the lead author of the clinical study and also the Director of the PRB’s Center for Advanced Obstetrical Care and Research housed at the DMC/Wayne State University (WSU) campus, where Ms. Delaney-Adams participated in the study and received regular obstetrical exams and treatment.
Added Dr. Hassan: “One of the best things about our Center is that we can bring the latest, state-of-the-art medical care to expectant mothers in Detroit, while conducting cutting-edge medical research.”
Reflecting on the happy outcome, Dr. Roberto Romero – the primary investigator of the successful clinical trial that helped bring Robert Delaney-Adams safely into the world – says it was a “compelling example of how this new therapy will be able to help many expectant mothers at risk for preterm delivery.
“The clinical study we just published [in the authoritative medical journal Ultrasound in Obstetrics & Gynecology] offers new hope to women everywhere,” added Dr. Romero. “Worldwide, more than 12 million expectant mothers – 500,000 of them in this country – give birth prematurely each year, and the results are often tragic. But the results of our three-year, international clinical trial show clearly that it’s possible to reduce the incidence of preterm delivery by half . . . simply by treating women who’ve been identified as at risk for the condition with an easy-to-assimilate form of the female hormone progesterone.
“The study in Ultrasound in Obstetrics and Gynecology documents the effect of progesterone therapy in women who are likely to deliver prematurely,” said Dr. Romero. “And when you see how it can help an expectant mother to avoid the problems often associated with preterm delivery, that’s very gratifying indeed.”
Ask Laura Delaney-Adams to describe the wonderful day when baby Robert entered the world, and the Detroit LPN won’t hesitate to reply.
“I was happy with the outcome, that’s for sure,” she says, while recalling the first time she held little Robert in her arms.
“I was very happy – and I’m just glad I found out about the DMC clinical trial when I did!”
Roberto Romero, MD
Sonia S. Hassan, MD
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