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duminică, 5 august 2012

NIH's PRB Progesterone Therapy To Combat Infant Mortality Adopted By State Of Michigan

The Michigan Department of Community Health (MDCH) has unveiled the state's Infant Mortality Reduction Plan, a strategy that includes significant recommendations developed from medical research conducted by the Perinatology Research Branch (PRB) of the Eunice Kennedy Shriver National Institute for Child Health and Human Development, National Institutes of Health (NICHD/NIH), at the Wayne State University School of Medicine.

Announced Aug. 1, the plan promotes the adoption of universal cervical length screening by ultrasound and the use of progesterone in women identified as high risk for premature birth. The use of progesterone in women with a short cervix can reduce the rate of preterm birth - the leading factor in infant mortality - by as much as 45 percent, according to research findings published by the PRB. The study, released last year, was conducted at more than 40 centers worldwide. Roberto Romero, M.D., branch chief of the PRB, was the principal investigator on behalf of NICHD/NIH. Wayne State was the lead center in the trial, led by Sonia Hassan, M.D., associate dean for maternal, perinatal and child health at WSU.

The ultrasound examination is simple to perform, painless and can be performed between the 19th and 24th weeks of pregnancy. Pregnant women with a cervix less than 20 millimeters are at very high risk for preterm delivery. If a woman is found to have a short cervix, she can be treated with vaginal progesterone. Treatment with vaginal progesterone reduced the rate of preterm birth, neonatal morbidity and respiratory distress syndrome. Women can self-administer a once-daily dose.

The recommendation that the state adopt the progesterone protocol was first introduced by Valerie M. Parisi, M.D., M.P.H., M.B.A., dean of the WSU School of Medicine, during the state's Call to Action to Reduce and Prevent Infant Mortality Summit in October 2011. The summit, convened by Gov. Rick Snyder to address the state's high rate of infant mortality, brought together hundreds of health care providers and stakeholders to develop recommendations to combat the problem.

"The strategies introduced by the state today will go a long way in dramatically reducing the state's infant mortality rate, which remains too high," Parisi said. "The key recommendations were developed through medical research conducted at the Perinatology Research Branch at Wayne State University, which demonstrates the branch's significant importance to the people of Michigan and the Detroit region."

The MDCH, headed by Director Olga Dazzo, said the strategies were selected because they reflect evidence-based practices that will reduce and prevent infant deaths.

While the 2010 state infant mortality rate set a new record low at 7.1 deaths per 1,000 live births, Michigan's rate remains higher than the national average of 6.1 deaths per 1,000 live births, according to the MDCH.

Premature birth is the leading cause of infant mortality in Michigan. The rate of premature birth increased more than 10 percent between 1998 and 2008. One of every eight babies born in Michigan - 295 in an average week - is born prematurely. And Michigan's rate of preterm birth (12.7 percent) exceeds the national average of 12.3 percent.

The new practices call for the state to partner with Wayne State University and the Detroit Medical Center to share progesterone therapy practices and develop protocol and implementation statewide. The state also will coordinate with the Medical Services Administration to assure benefit coverage for universal ultrasound screening of pregnant women and progesterone administration for Medicaid covered pregnancies.

"The implementation of universal cervical ultrasound screening for all pregnant women to identify women at risk for premature birth, and the use of vaginal progesterone, will be critical in the plan to reduce the rate of preterm birth and infant mortality," said Hassan.

Statewide universal ultrasound screening, Parisi said, would be cost effective if the scan costs no more than $186. With Michigan's 110,000 births annually, the potential cost savings would be $19,603,380 (in 2010 dollars) for every 100,000 women screened.

Premature births are costly. Nationally, preterm birth is a $26 billion annual problem. The CDC reports that preterm births topped the list of the most expensive hospitalizations in Michigan in 2007. Each premature birth in the state costs an average of $102,103 at the time of discharge from the hospital. That is 14 times the cost of a normal birth.

The state's other strategies include promoting the adoption of policies to eliminate medically unnecessary deliveries before the 39th week, promoting safe infant sleep practices to prevent suffocation, expanding home-visiting programs to support vulnerable women and infants, programs to reduce unintended pregnancies, and weaving social determinants of health into all its strategies to reduce racial and ethnic disparities in infant mortality.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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joi, 15 decembrie 2011

Vaginal Progesterone Reduces Preterm Birth, Neonatal Morbidity And Mortality In Women At Risk

Main Category: Pregnancy / Obstetrics
Also Included In: Menopause; Women's Health / Gynecology
Article Date: 15 Dec 2011 - 2:00 PST

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Women with a short cervix should be treated with vaginal progesterone to prevent preterm birth, according to a landmark study by leading obstetricians around the world. Vaginal progesterone decreased the rate of preterm birth by 42%, and significantly reduced the rate of respiratory distress syndrome and the need for mechanical ventilation, as well as a composite of several complications of premature newborns (e.g. infection, necrotizing enterocolitis, intracranial hemorrhage, etc.). An early online version of the study was published today in the American Journal of Obstetrics and Gynecology (AJOG), and is available on the AJOG website free of charge.

"Our analysis provides compelling evidence that vaginal progesterone prevents preterm birth and reduces neonatal morbidity/mortality in women with a short cervix," said lead investigator Dr. Roberto Romero, Chief of the Perinatology Research Branch and Head of the Program in Perinatal Research and Obstetrics of the Division of Intramural Research for the NICHD/NIH/DHHS, Bethesda, MD and Detroit, MI. "Importantly, progesterone reduced early preterm birth (those occurring before 33 or 28 weeks of gestation). These immature babies are at the greatest risk for complications, death, and long-term disability (e.g. cerebral palsy). Progesterone also decreased a fraction of 'late preterm births,' which are the most common preterm deliveries. The profile of adverse events was no different from placebo.

Follow-up studies of babies exposed to progesterone in utero to the age of 18 or 24 months showed no evidence of any behavioral or physical problems. 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. This strategy also allows the identification of women at risk for preterm delivery during their first pregnancy. Other strategies, which are based on treating women with a previous preterm birth, do not address the challenge of prevention in women with their first pregnancy."

Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Moreover, preterm birth is also the main cause of infant mortality (death to the age of one year). Approximately 12.9 million births worldwide are preterm, of which 92.3% occur in Africa, Asia, Latin America, and the Caribbean. In the United States and Europe, there are 1,000,000 preterm births per year.

Progesterone is a natural hormone produced by the ovary during the menstrual cycle and in early pregnancy, and subsequently, in the placenta. A decline in progesterone action is considered to be important for the onset of labor. If such a decline occurs in the mid-trimester, cervical shortening may lead to the onset of preterm labor. The administration of progesterone is postulated to work by maintaining a high concentration of the hormone in the uterine cervix.

Several studies had evaluated the administration of vaginal progesterone versus placebo to prevent preterm birth when a short cervix was found by ultrasound in the mid-trimester of pregnancy. What is unique about the study published today is that investigators worldwide pooled the data from the different studies and performed a meta-analysis of individual patient data (IPD). This is the "gold standard" for summarizing evidence across clinical trials. It has the advantage of increasing the power to detect differences in efficacy and adverse events, and also allows subgroup analyses that may not have been possible in each individual study.

The IPD meta-analysis included five high-quality trials of vaginal progesterone versus placebo, was conducted at multiple centers in both developed and developing countries, and included a total of 775 women and 927 infants. The primary endpoints were: 1) preterm birth at <33 weeks; and 2) a composite index of perinatal morbidity and mortality. The authors also studied other secondary endpoints and explored the effect of cervical length, a history of previous preterm birth, maternal age, race/ethnicity, and body mass index on progesterone action.

The results were remarkably consistent and significant across trials performed in different parts of the world. Administering vaginal progesterone to asymptomatic women with a short cervix revealed by sonogram in the mid-trimester was associated with a 42% reduction in the rate of preterm birth before 33 weeks of gestation. There was also a significant reduction in the risk of preterm birth before 35, 34, and 28 weeks.

The study also found a 43% decrease in neonatal morbidity and mortality. Vaginal progesterone significantly reduced the risk of respiratory distress syndrome by 52%, and there was significantly lower admission to NICUs (placebo, 20.7% vs. progesterone, 29.1%).

Results of previous trials about the effects of vaginal progesterone or injectable progestins (synthetic compounds with progesterone action) in women with a twin gestation had been negative. However, a subset of patients in the study published today focused on women with a twin gestation and a short cervix. In this particular group, vaginal progesterone reduced the rate of preterm birth at <33 weeks by 30% and significantly reduced the composite neonatal morbidity/mortality of twins. Dr. Romero indicated that a study of vaginal progesterone in twin pregnancies with a short cervix is urgently needed to confirm these findings because the reduction in preterm birth did not reach significance (most likely due to the small number of twins available to study).

A major finding of this study is that progesterone benefits not only women who have a short cervix, but also those who have a prior preterm birth and a short cervix. This has practical implications, because vaginal progesterone is a less expensive and less invasive alternative than the placement of a cervical suture (cerclage) in patients who had a previous preterm birth and have a short cervix.

"The results of this analysis of five large randomized trials have the potential to result in a sea change in obstetrical practice in the U.S. and Europe and eventually in the rest of the world," commented AJOG Co-Editor-in-Chief, Thomas J. Garite, MD. "Prematurity is the leading cause of death and damage for newly born babies and despite enormous efforts, no impact has been made in the rate of preterm birth, which is actually rising in recent years."

As advocated in an accompanying editorial by C. Andrew Combs, MD, PhD, Obstetrix Medical Group, San Jose, CA, in the print version of the Journal, the potential for reducing prematurity lies in implementing routine vaginal ultrasound for all pregnant women in the middle months of pregnancy to measure the length of the cervix and if a short cervix is found, treat these patients with progesterone. The majority of premature births occur in women with no risk factors, so this approach has real potential to make an impact in the overall premature birth rate. Two recently published cost analysis studies, suggest that this approach can not only save lives and prevent the devastating damages often caused by prematurity, but can also result in a annual savings of nearly 1/2 billion dollars in health care costs in the U.S. alone.

Article adapted by Medical News Today from original press release. Source: Elsevier
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