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March of Dimes: Drug to prevent preterm birth needs prompt FDA approval
August 29, 2006The March of Dimes today urged Food and Drug Administration officials to promptly approve a commercial progesterone therapy that appears to prevent some premature births.
Dr. Nancy Green, March of Dimes medical director, testified before the FDA Advisory Committee for Reproductive Health Drugs, which met to discuss "Gestiva," also known as 17 alpha-hydroxyprogesterone or 17-P.
"Studies of progesterone injections offer promise that the risk of recurrent preterm births will be reduced in a select group of women who already had a baby born too soon," said Dr. Green. "We hope the FDA will approve the licensing of this drug so those women can be helped by this treatment."
Nationwide, nearly a half million babies are born too soon each year and babies who survive face risks of lifelong developmental challenges, such as cerebral palsy, mental retardation, chronic lung disease, and vision and hearing loss. The Institute of Medicine estimates the national cost of premature birth in 2005 exceeded $26 billion.
Progesterone is given as weekly injections during the second half of pregnancy. FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid.
Obstetricians who treat women with a high risk pregnancy, such as those with a history of spontaneous preterm birth, often offer progesterone treatments. A 2005 survey found 67 percent of these obstetricians use progesterone compared to 38 percent in 2003.
A large study found that for women who had a previous premature baby 17-P reduced the preterm birth rate by 33 percent compared to a control group. The March of Dimes estimated that if all women eligible for the progesterone therapy had received it, nearly 10,000 premature births might have been prevented in 2003.
While there is no evidence that 17-P has an adverse effect on infants, the March of Dimes remains cautious about its use and is concerned that women without a previous premature baby are receiving the injections.
Dr. Green asked the FDA to monitor the drug for possible adverse effects on infants. She also recommended the FDA direct that, given what is known about its efficacy, Gestiva should only be used by women with a history of spontaneous premature birth.
March of Dimes Birth Defects Foundation
Nationwide, nearly a half million babies are born too soon each year and babies who survive face risks of lifelong developmental challenges, such as cerebral palsy, mental retardation, chronic lung disease, and vision and hearing loss. The Institute of Medicine estimates the national cost of premature birth in 2005 exceeded $26 billion.
Progesterone is given as weekly injections during the second half of pregnancy. FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid.
Obstetricians who treat women with a high risk pregnancy, such as those with a history of spontaneous preterm birth, often offer progesterone treatments. A 2005 survey found 67 percent of these obstetricians use progesterone compared to 38 percent in 2003.
A large study found that for women who had a previous premature baby 17-P reduced the preterm birth rate by 33 percent compared to a control group. The March of Dimes estimated that if all women eligible for the progesterone therapy had received it, nearly 10,000 premature births might have been prevented in 2003.
While there is no evidence that 17-P has an adverse effect on infants, the March of Dimes remains cautious about its use and is concerned that women without a previous premature baby are receiving the injections.
Dr. Green asked the FDA to monitor the drug for possible adverse effects on infants. She also recommended the FDA direct that, given what is known about its efficacy, Gestiva should only be used by women with a history of spontaneous premature birth.
March of Dimes Birth Defects Foundation
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Experts call for acceleration of research and interventions for prematurity and stillbirth
A new report issued today identifies the enormous global impact of preterm birth and stillbirth-and what can be done to decrease it. Globally, an estimated 13 million babies are born preterm each year.
Prepregnancy, obesity and gestational weight gain influence risk of preterm birth
Researchers at Boston University School of Medicine's (BUSM) Slone Epidemiology Center and Boston University School of Public Health (BUSPH) have found that pre-pregnancy obesity and gestational weight gain are associated with an increased risk of preterm birth in African American participants from the Black Women's Health Study.
Prevention is key research goal for premature babies, scientists say
Family history, infection and stress all may play a role in raising a woman's risk of having a premature baby - but they don't fully explain why some women give birth too soon and others don't.
Study identifies factors associated with growth of fetus in first trimester and subsequent outcomes
Factors such as maternal high blood pressure and high hematocrit levels (the proportion of blood that consists of red blood cells) are associated with a greater likelihood of restricted fetal growth during the first trimester, with restricted growth linked to an increased risk of preterm birth and low birth weight.
Yale researchers may have uncovered the mechanism by which progesterone prevents preterm birth
Researchers at Yale School of Medicine believe they may have discovered how the hormone progesterone acts to prevent preterm birth.
Genes that regulate maternal inflammatory response, bacterial vaginosis and preterm birth related
In a study to be presented today at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting, The Pregnancy Meeting ™, in Chicago, researchers will show the use of haplotype tagging (hap-tag) single-nucleotide polymorphisms (SNPs) to study the relationship between genetic predispositions, an environmental factor - bacterial vaginosis, and preterm birth.
Ultrasound measurement of fetal adrenal gland a better predictor of preterm birth
In a study to be presented today at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting, The Pregnancy Meeting ™, in Chicago, researchers will unveil findings that show that measuring the fetal zone of the adrenal gland is a better predictor of pre-term birth than measuring cervical length.
Genes of pregnant women and their fetuses can increase the risk of preterm labor
New evidence that genetics play a significant role in some premature births may help explain why a woman can do everything right and still give birth too soon.
NIH scientists identify maternal and fetal genes that increase preterm birth risk
Researchers at the National Institutes of Health have identified DNA variants in mothers and fetuses that appear to increase the risk for preterm labor and delivery. The DNA variants were in genes involved in the regulation of inflammation and of the extracellular matrix, the mesh-like material that holds cells within tissues.
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