Utilization, adherence, and outcomes of 17-alpha hydroxyprogesterone caproate for recurrent spontaneous preterm birth prevention

References

• WHO. Preterm birth: Key facts; 2018 [cited 2020 Nov 20]. Available from: http://www.who.int/en/news-room/fact-sheets/detail/preterm-birth.
   Google Scholar
• Goldenberg RL, Culhane JF, Iams JD, et al. Epidemiology and causes of preterm birth. Lancet. 2008;371(9606):75–84.
   PubMed Web of Science ®Google Scholar
• March of Dimes. Nowhere to go: maternity care deserts across the U.S.2020 report; 2021 [cited 2021 Feb 12] Available from: https://www.marchofdimes.org/materials/MOD2020_REPORT_CARD_and_POLICY_ACTIONS_BOOKLET_FIN.pdf.
   Google Scholar
• Menon R. Spontaneous preterm birth, a clinical dilemma: etiologic, pathophysiologic and genetic heterogeneities and racial disparity. Acta Obstet Gynecol Scand. 2008;87(6):590–600.
   PubMed Web of Science ®Google Scholar
• Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. New Eng J Med. 2003;348(24):2379–2385.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. FDA briefing document NDA 021945 Hydroxyprogesterone Injection (trade name Makena); 2019 [cited 2020 Nov 20]. Available from: https://www.fda.gov/media/132003/download.
   Google Scholar
• American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964–973.
   PubMed Web of Science ®Google Scholar
• Society for Maternal-Fetal Medicine Publications Committee. The choice of progestogen for the prevention of preterm birth in women with singleton pregnancy and prior preterm birth. American Journal of Obstetrics and Gynecology. 2017;216(3):B11–B13.
   PubMed Web of Science ®Google Scholar
• Society for Maternal-Fetal Medicine. SMFM statement: use of 17-alpha hydroxyprogesterone caproate for prevention of recurrent preterm birth. Am J Obstet Gynecol. 2020;223(1):B16–b18.
   Web of Science ®Google Scholar
• Chang CY, Nguyen CP, Wesley B, et al. Withdrawing approval of Makena – a proposal from the FDA Center for Drug Evaluation and Research. N Engl J Med. 2020;383(24):e131.
   PubMed Web of Science ®Google Scholar
• Gandell DL, Randell MD, Gudeman JL. FDA approved vs. Pharmacy compounded 17-OHPC-current issues for obstetricians to consider in reducing recurrent preterm birth. Curr Med Res Opin. 2020;36(8):1393–1401.
   PubMed Web of Science ®Google Scholar
• Greene MF, Klebanoff MA, Harrington D. Preterm birth and 17OHP – why the FDA should not withdraw approval. New England J Med. 2020;383(24):e130.
   PubMed Web of Science ®Google Scholar
• AMAG Pharmaceuticals. Comment from AMAG Pharmaceuticals, Inc.; 2020 [cited 2021 Feb 12]. Available from: https://www.regulations.gov/comment/FDA-2020-N-2029-0051.
   Google Scholar
• Hydery T, Price MK, Greenwood BC, et al. Evaluation of progesterone utilization and birth outcomes in a state Medicaid plan. Pharmacotherapy. 2017;37(10):1328–1334.
   PubMed Web of Science ®Google Scholar
• Nelson DB, McIntire DD, McDonald J, et al. 17-Alpha hydroxyprogesterone caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study. Am J Obstet Gynecol. 2017;216(6):600.e601–600.e609.
   Web of Science ®Google Scholar
• Turitz AL, Bastek JA, Purisch SE, et al. Patient characteristics associated with 17-alpha hydroxyprogesterone caproate use among a high-risk cohort. Am J Obstetr Gynecol. 2016;214(4):536.e531–536.e535.
   Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Carter EB, Cahill AG, Olsen MA, et al. Practical considerations with 17-hydroxyprogesterone caproate for preterm birth prevention: does timing of initiation and compliance matter? J Perinatol. 2019;39(9):1182–1189.
   PubMed Web of Science ®Google Scholar
• Edwards AM, Lowry SA, Mikovich S, Forinash AB, et al. Adherence rates and outcomes for 17-hydroxyprogesterone caproate use in women with a previous history of preterm birth. Am J Obstet Gyneco lMFM. 2020;2(3):100166.
   PubMed Web of Science ®Google Scholar
• Blackwell SC, Gyamfi-Bannerman C, Biggio JR, Jr, et al. 17-OHPC to prevent recurrent preterm birth in singleton gestations (PROLONG Study): a multicenter, international, randomized double-blind trial. Am J Perinatol. 2020;37(02):127–136.
   PubMed Web of Science ®Google Scholar
• Rebarber A, Ferrara LA, Hanley ML, et al. Increased recurrence of preterm delivery with early cessation of 17-alpha-hydroxyprogesterone caproate. Am J Obstet Gynecol. 2007;196(3):224.e1–e221-224.
   PubMed Web of Science ®Google Scholar
• Sammour MB, el-Kabarity H, Fawzy MM, et al. Prevention and treatment of pregnancy-induced hypertension (preeclampsia) with progestogens. J Steroid Biochem Mol Biol. 2005;97(5):439–440.
   PubMed Web of Science ®Google Scholar
• Ngai I, Sheen J-J, Garretto D, et al. Progesterone (17α-hydroxyprogesterone caproate) for prevention of preterm birth and preeclampsia. 2014;123:162S.
   Google Scholar
• Association of State and Territorial Health Officials. Increasing state health agency capacity to improve 17P utilization; 2015 [cited 2020 Dec 3]. Available from: http://www.astho.org/Maternal-and-Child-Health/ASTHO-17P-Issue-Brief/.
   Google Scholar
• Yee LM, Liu LY, Sakowicz A, et al. Racial and ethnic disparities in use of 17-alpha hydroxyprogesterone caproate for prevention of preterm birth. Am J Obstet Gynecol. 2016;214(3):374.e371–376.
   Web of Science ®Google Scholar
• Bousleiman SZ, Rice MM, Moss J, et al. Use and attitudes of obstetricians toward 3 high-risk interventions in MFMU network hospitals. Am J Obstet Gynecol. 2015;213(3):398.e391–311.
   Web of Science ®Google Scholar
• Stringer EM, Vladutiu CJ, Manuck T, et al. 17-Hydroxyprogesterone caproate (17OHP-C) coverage among eligible women delivering at 2 North Carolina hospitals in 2012 and 2013: A retrospective cohort study. Am J Obstet Gynecol. 2016;215(1):105.e101–105.e112.
   Web of Science ®Google Scholar
• Orsulak MK, Block-Abraham D, Gee RE. 17alpha-hydroxyprogesterone caproate access in the Louisiana Medicaid population. Clin Ther. 2015;37(4):727–732.
   PubMed Web of Science ®Google Scholar
• Cross-Barnet C, Benatar S, Courtot B, et al. Inequality and innovation: barriers and facilitators to 17P administration to prevent preterm birth among Medicaid participants. Matern Child Health J. 2018;22(11):1607–1616.
   PubMed Web of Science ®Google Scholar
• Rittenberg C, Sullivan S, Istwan N, et al. Clinical characteristics of women prescribed 17 alpha-hydroxyprogesterone caproate in the community setting. Am J Obstet Gynecol. 2007;197(3):262.e261–264.
   Web of Science ®Google Scholar
• Lucas B, Poole-Yaeger A, Istwan N, et al. Pregnancy outcomes of managed Medicaid members prescribed home administration of 17 alpha-hydroxyprogesterone caproate. Am J Perinatol. 2012;29(7):489–496.
   PubMed Web of Science ®Google Scholar
• DeNoble AE, Wynn CE, Weaver KE, et al. Factors associated with utilization of 17-hydroxyprogesterone caproate for the prevention of recurrent preterm birth. Am J Perinatol. 2020;37(3):264–270.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. CDER proposes withdrawal of approval for Makena; 2020 [cited 2020 Dec 15]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/cder-proposes-withdrawal-approval-makena.
   Google Scholar
• Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials. Lancet. 2021;397(10280):1183–1194.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. CDER perspective on recently published results of EPPPIC meta-analysis; 2021 [cited 2021 May 1]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/cder-perspective-recently-published-results-epppic-meta-analysis.
   Google Scholar
• Berhie SH, Riley LE, Bryant AS. Disparities in 17-hydroxyprogesterone caproate offer and uptake in pregnancies at a risk of preterm birth. Am J Perinatol. 2019;36(10):1066–1071.
   PubMed Web of Science ®Google Scholar
• Stringer EM, Vladutiu CJ, Batra P, et al. Operationalizing 17alpha-hydroxyprogesterone caproate to prevent recurrent preterm birth: definitions, barriers, and next steps. Obstet Gynecol. 2016;128(6):1397–1402.
   PubMed Web of Science ®Google Scholar
• Ness A, Dias T, Damus K, et al. Impact of the recent randomized trials on the use of progesterone to prevent preterm birth: a 2005 follow-up survey. Am J Obstet Gynecol. 2006;195(4):1174–1179.
   PubMed Web of Science ®Google Scholar
• Haidar ZA, Moussa HN, Hosseini Nasab S, et al. Effect of partial compliance on the prevention of recurrent preterm birth in women receiving weekly 17 alpha-hydroxyprogesterone caproate injections. J Matern Fetal Neonat Med 2017;30(24):2926–2932.
   PubMed Web of Science ®Google Scholar
• Ning A, Vladutiu CJ, Dotters-Katz SK, et al. Gestational age at initiation of 17-alpha hydroxyprogesterone caproate and recurrent preterm birth. Am J Obstet Gynecol. 2017;217(3):371.e371–371.e377.
   Web of Science ®Google Scholar
• Rouholamin S, Zarean E, Sadeghi L. Evaluation the effect of 17-alpha hydroxyprogesterone caproate on gestational diabetes mellitus in pregnant women at risk for preterm birth. Adv Biomed Res. 2015;4:242.
   PubMedGoogle Scholar
• Gyamfi C, Horton AL, Momirova V, et al. The effect of 17-alpha hydroxyprogesterone caproate on the risk of gestational diabetes in singleton or twin pregnancies. Am J Obstet Gynecol. 2009;201(4):392.e391–395.
   Web of Science ®Google Scholar
• Makena Care Connection AP. Makena (hydroxyprogesterone caproate injection) billing guide; 2018 [cited 2020 Dec 2]. Available from: https://makenahcp.com/wp-content/uploads/2018/11/PP-MKN-US-00408-makena-billing-guide.pdf.
   Google Scholar
• Amaral LM, Cornelius DC, Harmon A, et al. 17-hydroxyprogesterone caproate significantly improves clinical characteristics of preeclampsia in the reduced uterine perfusion pressure rat model. Hypertension. 2015;65(1):225–231.
   PubMed Web of Science ®Google Scholar