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In the United States, nearly 543,000 premature babies were born in 2006. Researchers have identified a therapy that has the potential to prevent thousands of these early deliveries. The drug is 17 Alpha-hydroxyprogesterone caproate, known as 17P. Preterm Deliveries Rising About 8 percent of babies born earlier than the 37th week of pregnancy will have a birth defect according to the research by a team of investigators from the March of Dimes, the U.S. Centers for Disease Control and Prevention (CDC), and several other major institutions. No one knows the causes, but the rate of premature deliveries in the United States is rising. A National Center for Health Statistics report, Births: Final data for 2006, National Vital Statistics Reports; Vol. 57, No. 7, shows that the preterm birth rate rose to 12.8 percent in 2006 — a 36 percent increase since the early 1980s. 17P Is Effective One study, reported in the New England Journal of Medicine (N Engl J Med 2003; 348:2379-85), showed that 17P treatment reduced preterm birth by 34 percent in women pregnant with a single baby who had a previous preterm delivery (one indicator of high risk for early labor in following pregnancies). Women who received weekly 17P injections starting at 16 to 20 weeks’ gestation had a significantly reduced risk of preterm delivery compared to women who received placebo injections. Infants whose mothers were treated with 17P also had significantly lower rates of severe complications. The children of the women who participated in the 2003 NIHCD showed no significant difference in the frequency of genital malformations between children who had been exposed in utero to 17P and children whose mothers had been given placebo. A follow up study of these children at 4 years showed that height, weight, head circumference, blood pressure, neurodevelopment, and scores for gender specific roles were comparable between the two groups How Does 17P Work? Researchers are not absolutely certain why the progesterone based treatment works. They do know that in most mammals, progesterone is produced by the placents during pregnancy. Medical researchers believe that this hormone helps keep the uterus in a quiescent state — preventing the contractions that lead to labor. A drop in the blood level of progesterone results in uterine contractions and labor (J Soc Gynecol Invest 2002; 9:125-36). It seems that supplementing the levels of progesterone, by administering 17P to women who are experiencing early labor, helps to keep the uterus from contracting and, in many cases, delays labor until the baby is safe. 17P is normally prescribed as a series of shots given weekly. The treatment begins between the 16th and 21st week of pregnancy. Multiple studies have found that women who received at least five injections of 17P, experienced a statistically significant reduction in NICU admissions and in preterm births. 17P does not prevent preterm deliveries with multiples Women who are pregnant with twins or multiples should not take 17P. Despite the low risk for side effects, it has not been shown to be more effective than a placebo in reducing the risk of preterm labor with multiples. Only women with a singleton pregnancy and who have a history of a previous singleton spontaneous preterm birth between 20 and weeks gestation are good candidates for 17P treatments. Does this help prevent early delivery due to incompentent or short cervix? Doctors and researchers are uncertain about whether progesterone therapy should be used with women who are in danger of early labor due to problems with the cervix. A 2007 study found that daily vaginal administration of 200 mg of progesterone reduced the rate of delivery before 34 weeks from 34% to 19% in women with a short cervix (N Eng J Med. 2007;357:462-469). The data is inconclusive and some recent studies have not found significant results. The American College of Obstetricians and Gynecologists allows 17P therapy for women with an incompentenet or short cervix since there is a chance that the treatments will help and the risk of serious side effects is small. Some studies suggest a procedure called cerclage, where the doctor puts a stitch in the cervix to help keep it closed until the baby is able to thrive outside the uterus (usually around the 37th week), may help reduce the risk of preterm delivery in some women who have cervical abnormalities and have had a previous preterm delivery. How is the 17P treatment administered? The progesterone preparation known as 17P is available only by prescription from compounding pharmacies that compound sterile products. It is normally dissolved in an oil suspension and given as a weekly shot into the muscle of the buttocks. !7P is also available as suppositories, although there is not enough research to determine whether that route is as effective as the injection. Are there any side effects of 17P therapy? The amount of progesterone produced during a normal pregnancy, mainly by the placenta, is greater than the pharmacologic doses employed in 17P treatments. Reported side effects in the mother have included sweling, itching and other local reactions at the site of the injection, hypersensitivity reactions, cough, dyspnea, and an increased risk of developing gestational diabetes.
March of Dimes - Preventing Premature Birth - Progesterone Treatment (17P) 17P Therapy ... Could Prevent Thousands of Premature Births (JAN. 31, 2005) Grand Rounds: Can progesterone therapy prevent preterm birth? First effective treatment for preterm births PPB MAJOR MILESTONES AND ADVANCES: 2000-2004 Hydroxyprogesterone Caproate USP (17 alpha-hydroxy-progesterone) - CIGNA Drugs In Pregnancy - 17 alpha-hydroxyprogesterone caproate (17OHPC) A BRIEF REVIEW OF PROGESTINS IN PREGNANCY (January 2008) Is 17-Hydroxyprogesterone Caproate (17P) Safe for the Baby During Use in Preterm Birth Prevention? EVIDENCE ON THE DEVELOPMENTAL AND REPRODUCTIVE TOXICITY OF Progesterone (PDF) Progesterone Prevents Preterm Birth for Some Women (short cervix) Optimizing the Use of 17P In Pregnant Managed Medicaid Members (PDF) Hydroxyprogesterone (17-alpha Hydroxyprogesterone Caproate) Twin Gestations Remain Associated with Risk for Preterm Delivery Prevention of recurrent preterm birth (PDF) A Trial of 17 Alpha-Hydroxyprogesterone Caproate to Prevent Prematurity in Twins 4-year Follow-Up Study of Children Exposed to 17P In Utero 17 Alpha Hydroxyprogesterone Caproate (17P) Optimizing the Use of 17P In Pregnant Managed Medicaid Members (PDF) Coverage of Alpha Hydroxyprogestrone (17P) - Illinois
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