Managed Care - January 2008 - (Page 52) ation of 17P beyond the 16–21 weeks’ gestation time line studied by Meis and colleagues has not been fully studied or reported in the literature. It is suggested that the optimal time frame for initiation of 17P treatment can be extended late into the 2nd trimester, as long as the woman receives at least the five weekly injections. Furthermore, the issue of dosage is still open for investigation. This means 17P can be effectively used in the Medicaid population, where there is often late initiation of prenatal care. The effect of missed weekly injections of 17P has not been previously reported in the literature. There is a suggestion that there is an impact on birth outcomes, as documented above. The women who missed doses of 17P contributed disproportionately to the overall NICU admission rate. However, these results should be interpreted with caution, as more study is needed. It is of note that the 17P treatment was well tolerated within the group and that there were no documented complications. CONCLUSION This comparative, observational study of birth outcomes in 104 pregnant women who had a confirmed history of preterm birth and were prescribed 17P showed that there were no significant differences in the birth outcomes between those who received the 17P injections from 16 to 21 weeks gestation compared to 22–34 weeks gestation. The high risk pregnant members with a previous confirmed history of preterm birth who had at least five injections during the course of their pregnancy had lower NICU admissions and premature births before 32 and before 37 weeks of gestation. The optimal time frame for initiation of 17P treatment and the ef- fect of missed weekly 17P injections on birth outcomes requires additional study. Use of 17P on a broader scale should be a strong consideration in treating high-risk pregnant women with a confirmed history of preterm birth, even if presenting after 21 weeks of gestation. REAL WORLD IMPLICATIONS As health care professionals continue to focus on reducing health care costs attributed to negative pregnancy outcomes, findings such as these provide additional support to the managed Medicaid industry in helping to identify better ways to reduce cost associated with preterm delivery while improving quality of care for pregnant women at risk. Treatment with 17P, initiated at 16–21 weeks gestation, has been shown to reduce the premature birth rate and NICU admission rate in women who have had a history of preterm birth. The effects of delaying 17P beyond the 16–21 weeks gestation time frame has not been studied or reported in the literature. This study clearly demonstrates that: The optimal (effective) time for initiation of 17P treatment can be extended beyond 16–21 weeks gestation. As long as the women receive at least five weekly injections, it appears that they will obtain the typical benefits of receiving 17P treatments. This hormone can still be used effectively in managed Medicaid populations, which are notorious for late initiation of prenatal care. REFERENCES ACOG (American College of Obstetrics and Gynecology). Progesterone recommended in certain high-risk pregnancies to help prevent preterm birth. Press release. Oct. 31, 2003. Katz A, Lancet M, Skornik J, et al. Teratogenicity of progestogens given during the first trimester of pregnancy. Ob- stet Gynecol. 1985;65(6):775–780. March of Dimes. “Drug to Prevent Preterm Birth Needs Prompt FDA Approval.” Press release, Aug. 26, 2006. Martin JA, Hamilton BE, Sutton PD, et al. Births: final data for 2002. Natl Vital Stat Rep. 2003;52(10):1–113. Martin JA, Hamilton BE, Sutton PD, et al. Births: final data for 2003. Natl Vital Stat Rep. 2005;54(2): 1–116. Mason MV, House KM, et al. 17 alpha-hydroxyprogesterone caproate usage in a Medicaid managed care plan and reduction in NICU days. Managed Care 2005;14(10):58–63. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17-alpha hydroxyprogesterone caproate. N Engl J Med 2003;349(13):1299. Mercer BM, Goldenberg RI, Moawad AH, et al. The preterm prediction study: effect of gestational age and cause of preterm birth on subsequent obstetric outcome. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. 1999;18(5 Pt 1):1216–1221. Michaelis J, Michaelis H, Gluck E, Keller S. Prospective studies of suspected association between certain drugs administered in early pregnancy and congenital malformations. Teratology. 1983;27:57–64. Petrini JR, Callaghan WM, Klebanoff M, et al. Estimated effect of 17-alpha hydroxyprogesterone caproate on preterm birth in the United States. Obstet Gynecol. 2005;105(2):267–272. Raman-Wilms L, Tseng AL, Wighardt S, et al. Fetal genital effects of first trimester sex hormone exposure: a meta-analysis. Obstet Gynecol. 1995;85(1):141–149. Anonymous. Reprotox. 1997, vol:92. Micromedix Inc. Available at: «http://www.reprotox.org». Verified Dec. 6, 2007. Resseguie LJ, Hick JF, Bruen JA, et al. Congenital malformations among offspring exposed in utero to progestins. Olmsted County, Minn., 1936–1974. Fertil Steril. 1985;43(4):514–519. Varma T, Morsman J. Evaluation of the use of hydroxyprogesterone hexanate in early pregnancy. Int J Gynecol Obstet. 1982;20:13–17. 52 MANAGED CARE / JANUARY 2008 http://www.reprotox.org
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