• Groundbreaking achievement in prevention of preterm birth

    January 2012

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    Around the world, preterm birth continues to be a serious health care problem. Every year, 12.9 million babies are born before their 37th week of development, making them subject to a variety of lifelong health complications. Despite the best efforts of physicians to prevent and slow these deliveries, there has been little success in actually reducing the number of preemies born each year.

    Thanks to the groundbreaking results of a worldwide study, researchers have found that screening women for short cervical length and treating appropriately with natural vaginal progesterone will cut delivery rates of early preterm babies by as much as 42 percent.

    In the meta-analysis study of patient data, lead researcher Robert Romero, MD, from the National Institute of Child Health & Human Development in Bethesda, Md., pooled results from five high-quality trials. Several participating medical facilities from around the world joined in the study – including UK Women’s Health Obstetrics & Gynecology and John O’Brien, MD, UK director of Maternal Fetal Medicine.

    To assess the role of a short cervix on preterm labor, expectant moms were screened with transvaginal ultrasound to evaluate cervical length during their second trimester of pregnancy. If determined to be short, women were treated with natural vaginal progesterone. Because a short cervix – one that measures less than 25mm – plays a significant role in preterm labor, ultrasound evaluation used in combination with hormonal therapy reduced the rate of early preterm deliveries by 42 percent and lowered complications for premature babies, including NICU admissions, mechanical ventilation and respiratory distress syndrome.

    Universal screening recommended

    The study, published in the Dec. 12, 2011, issue of the American Journal of Obstetrics and Gynecology, presents significant positive findings in the fight against preterm labor for women with no previous history of the condition. The study also sheds new light on the necessity of screening every woman for cervical length even if they are not in a high-risk population. By detecting patients at risk for early delivery, health care costs could be cut by $500 million and up to 45,000 preterm births each year could be prevented.

    The study sheds new light on the necessity of screening every woman for cervical length even if they are not in a high-risk population. 

    “The authors of this study recommend that transvaginal sonographic measurement of the cervix be performed in all pregnant women between 19 to 24 weeks of gestation to assess the risk of preterm delivery,” wrote the lead researcher in an online statement. “This strategy also allows the identification of women at risk for preterm delivery during their first pregnancy.”

    Early preterm delivery affected most

    While cervical screening in combination with progesterone use showed the most benefit in preventing early preterm labor, the approach was only marginally as effective for late preterm deliveries. Early preterm labor may occur between 28 and 32 weeks gestation and may have a significant impact on a baby’s quality of life by raising the risk for neurologic delays, spectrum disorders, retinopathies and cerebral palsy. For these babies, study results showed a 42 percent reduction in preterm delivery rates.

    Late preterm births, or babies delivered between 34 and 36 weeks, were reduced by an estimated 18 percent. Late preterm births make up 70 percent of all early deliveries worldwide, and while these babies typically have fewer long-term complications, they remain a serious health care issue.

    Results of the study also showed significant benefit for mothers carrying multiples – reducing the rate of preterm labor by 30 percent. However, the study notes that further research is needed to properly assess progesterone’s impact on women carrying more than one baby. Because the study looked at only a few twin gestations, the results were not considered statistically significant.

    Implications for practice

    Reducing health care disparities such as preterm labor continues to be a top priority for health leaders around the world. Proper utilization of universal screening for short cervical length can be a powerful predictor of preterm labor risk. This research reinforces the benefit of screening each and every pregnant woman in an effort to improve delivery outcomes and reduce neonatal morbidity and mortality rates among all populations and ethnic groups.

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Page last updated: 8/7/2015 2:29:11 PM
  • What the news means for you

    Dramatic difference in identifying those at risk for preterm labor

    John O’Brien, MD
    Maternal Fetal Medicine

    Wright, Heather, MDThe results of this study are making a dramatic difference in the way we identify patients at risk for preterm labor. Even though general trends for the last 12 months have begun to show a slight drop in preterm delivery rates, we are still very far from seeing those numbers fall worldwide without a consistent, effective therapy like this in place.

    “We … feel hopeful that screening every woman will have a significant impact on preterm births as well as the complications many babies often face after delivery.” 

    Role of progesterone

    Progesterone is a naturally occurring female hormone produced by the ovaries during the first several weeks of pregnancy – a job later taken over by the placenta. Necessary for the support of pregnancy, falling progesterone rates are just one of a series of factors associated with the onset of labor. If this decline happens midtrimester, the cervix will begin to shorten, or thin out, in preparation for birth. Use of vaginal progesterone helps keep these levels within normal limits, preventing the cervix from thinning and reducing the chances of an early delivery.

    Patented process developed at UK

    Working directly with Dr. Robert Romero, the lead researcher, on this research was very important to all of us at UK Women’s Health Obstetrics & Gynecology. For the last nine years we have been frontrunners in progesterone therapy and currently hold a patent for the process.

    For this particular study, we were one of several medical facilities that first identified patients with a short cervix and then treated some of them with vaginal progesterone and some with a placebo. After tracking patients and results for several years, we submitted this information to the study, where it was combined with the results of other medical professionals from around the world. Being part of this study is significant for us because we were the only Kentucky-based medical facility involved in this leading edge therapy for preterm birth.

    “We now screen every woman for a cervical length of 25mm or less even if she has no history of preterm labor and follow up with this therapy if indicated.” 

    Study presents clear picture of how women can benefit

    This study is what we call a “meta-analysis,” which is often referred to as the gold standard of research techniques. By analyzing a variety of patient data that has been carefully collected, we are able to see a larger, clearer picture of how many women can benefit from proper screening of the cervix and natural progesterone use.

    This study was the first to take a closer look at several factors not previously explored.

    • First, women with a cervical length of 25mm met the criteria for treatment – other studies have treated only if the length was 20mm or less.
    • Second, patients were evaluated regardless of whether they had any history of preterm labor. There have been many studies of women with previous preterm births, but this is the first to identify risk factors before the fact.
    • Finally, side effects on fetal development from use of natural progesterone were also carefully considered. In the short term, we have not been able to identify any side effects from its use and feel hopeful that screening every woman will have a significant impact on preterm births as well as the complications many babies often face after delivery.

    UK screens every pregnant woman

    In our clinic here at UK HealthCare, we now screen every woman for a cervical length of 25mm or less even if she has no history of preterm labor, and we follow up with this therapy if indicated. This allows us to identify women who may be at risk for delivering before their 37th week and offer treatment to prevent early delivery as well as its potential complications.

    I hope to see universal screening standards and progesterone therapy put into place across the Commonwealth of Kentucky and to see the process adopted worldwide for the prevention of preterm deliveries.

    Dr. O’Brien is chief of maternal fetal medicine at UK HealthCare and an associate professor of obstetrics and gynecology in the UK College of Medicine.

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