163
Views
0
CrossRef citations to date
0
Altmetric
REVIEW

Challenges in Using Progestin to Prevent Singleton Preterm Births: Current Knowledge and Clinical Advice

&
Pages 119-130 | Received 09 Jun 2023, Accepted 23 Oct 2023, Published online: 22 Jan 2024

References

  • American College of O, Gynecologists’ Committee on Practice B-O. Prediction and prevention of spontaneous preterm birth: ACOG Practice Bulletin, Number 234. Obstet Gynecol. 2021;138(2):e65–e90. doi:10.1097/AOG.0000000000004479
  • Ely DM, Driscoll AK. Infant mortality in the United States, 2020: data from the period linked birth/infant death file. Natl Vital Stat Rep. 2022;71(5):1–18.
  • Chawanpaiboon S, Vogel JP, Moller AB, et al. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019;7(1):e37–e46. doi:10.1016/S2214-109X(18)30451-0
  • Eichenwald EC, Stark AR. Management and outcomes of very low birth weight. N Engl J Med. 2008;358(16):1700–1711. doi:10.1056/NEJMra0707601
  • Himpens E, Van den Broeck C, Oostra A, Calders P, Vanhaesebrouck P. Prevalence, type, distribution, and severity of cerebral palsy in relation to gestational age: a meta-analytic review. Dev Med Child Neurol. 2008;50(5):334–340. doi:10.1111/j.1469-8749.2008.02047.x
  • American College of Obstetricians and Gynecologists. Executive summary: neonatal encephalopathy and neurologic outcome, second edition. Report of the American College of Obstetricians and Gynecologists’ Task Force on Neonatal Encephalopathy. Obstet Gynecol. 2014;123(4):896–901. doi:10.1097/01.AOG.0000445580.65983.d2
  • Crump C. An overview of adult health outcomes after preterm birth. Early Hum Dev. 2020;150:105187. doi:10.1016/j.earlhumdev.2020.105187
  • McIntire DD, Leveno KJ. Neonatal mortality and morbidity rates in late preterm births compared with births at term. Obstet Gynecol. 2008;111(1):35–41. doi:10.1097/01.AOG.0000297311.33046.73
  • Nelson DB, Spong CY. Seasonality associated with preterm birth-are we borrowing from our children? JAMA Netw Open. 2022;5(2):e2145808. doi:10.1001/jamanetworkopen.2021.45808
  • Frey HA, Klebanoff MA. The epidemiology, etiology, and costs of preterm birth. Semin Fetal Neonatal Med. 2016;21(2):68–73. doi:10.1016/j.siny.2015.12.011
  • Waitzman NJ, Jalali A, Grosse SD. Preterm birth lifetime costs in the United States in 2016: an update. Semin Perinatol. 2021;45(3):151390. doi:10.1016/j.semperi.2021.151390
  • March of Dimes full report card; 2022. Available from: https://www.marchofdimes.org/peristats/data?top=3&lev=1&stop=60®=99&obj=1&slev=1. Accessed May 1, 2023.
  • Hamilton BE, Martin JA, Osterman MJK. Births: provisional data for 2021. In: Vital Statistics Rapid Release. Hyattsville, MD: National Center for Health Statistics; 2022:20.
  • Culhane JF, Goldenberg RL. Racial disparities in preterm birth. Semin Perinatol. 2011;35(4):234–239. doi:10.1053/j.semperi.2011.02.020
  • Martin JA, Osterman MJ, Kirmeyer SE, Gregory EC. Measuring Gestational Age in Vital Statistics Data: transitioning to the Obstetric Estimate. Natl Vital Stat Rep. 2015;64(5):1–20.
  • Buhimschi CS, Schatz F, Krikun G, Buhimschi IA, Lockwood CJ. Novel insights into molecular mechanisms of abruption-induced preterm birth. Expert Rev Mol Med. 2010;12:e35. doi:10.1017/S1462399410001675
  • Norwitz ER, Robinson JN, Challis JR. The control of labor. N Engl J Med. 1999;341(9):660–666. doi:10.1056/NEJM199908263410906
  • Csapo AI, Pulkkinen M. Indispensability of the human corpus luteum in the maintenance of early pregnancy. Luteectomy evidence. Obstet Gynecol Surv. 1978;33(2):69–81. doi:10.1097/00006254-197802000-00001
  • Hanssens MC, Selby C, Symonds EM. Sex steroid hormone concentrations in preterm labour and the outcome of treatment with ritodrine. Br J Obstet Gynaecol. 1985;92(7):698–702. doi:10.1111/j.1471-0528.1985.tb01451.x
  • Peavey MC, Wu SP, Li R, et al. Progesterone receptor isoform B regulates the Oxtr-Plcl2-Trpc3 pathway to suppress uterine contractility. Proc Natl Acad Sci U S A. 2021;118(11):e2011643118.
  • Nadeem L, Shynlova O, Mesiano S, Lye S. Progesterone via its type-a receptor promotes myometrial gap junction coupling. Sci Rep. 2017;7(1):13357. doi:10.1038/s41598-017-13488-9
  • Merlino AA, Welsh TN, Tan H, et al. Nuclear progesterone receptors in the human pregnancy myometrium: evidence that parturition involves functional progesterone withdrawal mediated by increased expression of progesterone receptor-A. J Clin Endocrinol Metab. 2007;92(5):1927–1933. doi:10.1210/jc.2007-0077
  • Condon JC, Hardy DB, Kovaric K, Mendelson CR. Up-regulation of the progesterone receptor (PR)-C isoform in laboring myometrium by activation of nuclear factor-kappaB may contribute to the onset of labor through inhibition of PR function. Mol Endocrinol. 2006;20(4):764–775. doi:10.1210/me.2005-0242
  • Shynlova O, Nadeem L, Dorogin A, Mesiano S, Lye SJ. The selective progesterone receptor modulator-promegestone-delays term parturition and prevents systemic inflammation-mediated preterm birth in mice. Am J Obstet Gynecol. 2022;226(2):249 e1–249 e21. doi:10.1016/j.ajog.2021.08.013
  • Johnson JW, Austin KL, Jones GS, Davis GH, King TM. Efficacy of 17 alpha-hydroxyprogesterone caproate in the prevention of premature labor. N Engl J Med. 1975;293(14):675–680. doi:10.1056/NEJM197510022931401
  • Hauth JC, Gilstrap LC, Brekken AL, Hauth JM. The effect of 17 alpha-hydroxyprogesterone caproate on pregnancy outcome in an active-duty military population. Am J Obstet Gynecol. 1983;146(2):187–190. doi:10.1016/0002-9378(83)91051-7
  • Keirse MJ. Progestogen administration in pregnancy may prevent preterm delivery. Br J Obstet Gynaecol. 1990;97(2):149–154. doi:10.1111/j.1471-0528.1990.tb01740.x
  • Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379–2385. doi:10.1056/NEJMoa035140
  • Spong CY, Meis PJ, Thom EA, et al. Progesterone for prevention of recurrent preterm birth: impact of gestational age at previous delivery. Am J Obstet Gynecol. 2005;193(3 Pt 2):1127–1131. doi:10.1016/j.ajog.2005.05.077
  • Romero R, Stanczyk FZ. Progesterone is not the same as 17 alpha-hydroxyprogesterone caproate: implications for obstetrical practice. Am J Obstet Gynecol. 2013;208(6):421–426. doi:10.1016/j.ajog.2013.04.027
  • Department of Health and Human Services, Food and Drug Administration. NDA 021945. Accelerated approval. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021945s000ltr.pdf. Accessed May 15, 2023.
  • Blackwell SC, Gyamfi-Bannerman C, Biggio JR, et al. PROLONG clinical study protocol: hydroxyprogesterone caproate to reduce recurrent preterm birth. Am J Perinatol. 2018;35(12):1228–1234. doi:10.1055/s-0038-1642062
  • Blackwell SC, Gyamfi-Bannerman C, Biggio 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(2):127–136. doi:10.1055/s-0039-3400227
  • The Food and Drug Administration (FDA). Final decision on the proposal to withdraw approval of Makena; 2023. Available from: https://www.regulations.gov/document/FDA-2020-N-2029-0385. Accessed May 18, 2023.
  • Nyugen CP. Makena (hydroxyprogesterone caproate injection). New drug application 021945/supplement 023; 2019. Available from: https://www.fda.gov/media/132431/download. Accessed May 15, 2023.
  • Nelson DB, McIntire DD, Leveno KJ. A chronicle of the 17-alpha hydroxyprogesterone caproate story to prevent recurrent preterm birth. Am J Obstet Gynecol. 2021;224(2):175–186. doi:10.1016/j.ajog.2020.09.045
  • Department of Health and Human Sergices, Food and Drug Administration. FDA Briefing Document NDA 021945. Hydroxyprogesterone caproate injection. BRUDAC meeting; 2019. Available from: https://www.fda.gov/media/132003/download. Accessed May 18, 2023.
  • Covis Pharma GmbH’s briefing materials in response to the center for drug research and evaluation’s notice of opportunity for a hearing and proposal to withdraw approval of Makena. Docket No FDA-2020-N-2029; 2022. Available from: https://pink.pharmaintelligence.informa.com/-/media/supporting-documents/pink-sheet/2022/10/covis_briefing_document.pdf?rev=874e6596db1344698aff43d4e9b89e22&hash=8F1553842F1864F84C17066D498A9411. Accessed May 11, 2023.
  • Department of Health and Human Sergices, Food and Drug Administration. Public hearing announcement involving the obstetrics, reproductive, and urologic drugs advisory committee; 2022. Available from: https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-public-participation-information-october-17-19-2022-hearing-announcement-involving. Accessed May 10, 2023.
  • Department of Health and Human Sergices, Food and Drug Administration. FDA commissioner and chief scientist announce decision to withdraw approval of Makena; 2023. Available from: https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena. Accessed May 15, 2023.
  • Armstrong J. Unintended consequences--the cost of preventing preterm births after FDA approval of a branded version of 17OHP. N Engl J Med. 2011;364(18):1689–1691. doi:10.1056/NEJMp1102796
  • Cohen AW, Copel JA, Macones GA, Menard MK, Riley L, Saade GR. Unjustified increase in cost of care resulting from U.S. Food and Drug Administration approval of Makena (17 alpha-hydroxyprogesterone caproate). Obstet Gynecol. 2011;117(6):1408–1412. doi:10.1097/AOG.0b013e31821c2d75
  • Silver RM, Cunningham FG. Deus ex Makena? Obstet Gynecol. 2011;117(6):1263–1265. doi:10.1097/AOG.0b013e31821c6fb1
  • US Food and Drug Administration. Makena (hydroxyprogesterone caproate injection) Information. Makena (hydroxyprogesterone caproate injection) Information. Available from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information#:~:text=FDA%20withdrew%20approval%20of%20Makena,longer%20shown%20to%20be%20effective. Accessed 02 November 2023.
  • Nelson DB, McIntire DD, McDonald J, Gard J, Turrichi P, Leveno KJ. 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 e1–600 e9. doi:10.1016/j.ajog.2017.02.025
  • Perrone M. FDA panel backs removal of unproven pregnancy drug. ABC News. ABC News Network; 2022.
  • Murphy CC, Cirillo PM, Krigbaum NY, Cohn BA. In utero exposure to 17 alpha-hydroxyprogesterone caproate and risk of cancer in offspring. Am J Obstet Gynecol. 2022;226(1):132 e1–132 e14. doi:10.1016/j.ajog.2021.10.035
  • Aaron DG, Cohen IG, Adashi EY. The FDA struggle to withdraw Makena: problems with the accelerated approval process. JAMA. 2022;328(24):2394–2395. doi:10.1001/jama.2022.22986
  • Rouse DJ, Caritis SN, Peaceman AM, et al. A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins. N Engl J Med. 2007;357(5):454–461. doi:10.1056/NEJMoa070641
  • Caritis SN, Rouse DJ, Peaceman AM, et al. Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial. Obstet Gynecol. 2009;113(2 Pt 1):285–292. doi:10.1097/AOG.0b013e318193c677
  • Briery CM, Veillon EW, Klauser CK, et al. Women with preterm premature rupture of the membranes do not benefit from weekly progesterone. Am J Obstet Gynecol. 2011;204(1):54 e1–5. doi:10.1016/j.ajog.2010.08.022
  • Briery CM, Klauser CK, Martin RW, Magann EF, Chauhan SP, Morrison JC. The use of 17-hydroxy progesterone in women with arrested preterm labor: a randomized clinical trial. J Matern Fetal Neonatal Med. 2014;27(18):1892–1896. doi:10.3109/14767058.2014.892922
  • Grobman WA, Thom EA, Spong CY, et al. 17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm. Am J Obstet Gynecol. 2012;207(5):390 e1–8. doi:10.1016/j.ajog.2012.09.013
  • Rozenberg P, Chauveaud A, Deruelle P, et al. Prevention of preterm delivery after successful tocolysis in preterm labor by 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial. Am J Obstet Gynecol. 2012;206(3):206 e1–9. doi:10.1016/j.ajog.2011.12.026
  • Hassan SS, Romero R, Vidyadhari D, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011;38(1):18–31. doi:10.1002/uog.9017
  • Norman JE, Marlow N, Messow CM, et al. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet. 2016;387(10033):2106–2116. doi:10.1016/S0140-6736(16)00350-0
  • Nelson DB, Lafferty A, Venkatraman C, et al. Association of vaginal progesterone treatment with prevention of recurrent preterm birth. JAMA Netw Open. 2022;5(10):e2237600. doi:10.1001/jamanetworkopen.2022.37600
  • McKay LA, Holford TR, Bracken MB. Re-analysis of the PREGNANT trial confirms that vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix. Ultrasound Obstet Gynecol. 2014;43(5):596–597. doi:10.1002/uog.13331
  • Romero R, Conde-Agudelo A, Da Fonseca E, et al. Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in singleton gestations with a short cervix: a meta-analysis of individual patient data. Am J Obstet Gynecol. 2018;218(2):161–180. doi:10.1016/j.ajog.2017.11.576
  • Cheung KW, Seto MTY, Ng EHY. Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2020;21(1):121. doi:10.1186/s13063-020-4067-z
  • Hoffman MK. Prediction and prevention of spontaneous preterm birth: ACOG Practice Bulletin, Number 234. Obstet Gynecol. 2021;138(6):945–946. doi:10.1097/AOG.0000000000004612
  • Yoon BH, Romero R, Park JY, et al. Antibiotic administration can eradicate intra-amniotic infection or intra-amniotic inflammation in a subset of patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2019;221(2):142 e1–142 e22. doi:10.1016/j.ajog.2019.03.018
  • Kenyon SL, Taylor DJ, Tarnow-Mordi W, Group OC. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group. Lancet. 2001;357(9261):979–988. doi:10.1016/s0140-6736(00)04233-1
  • March of Dimes. Nowhere to Go: maternity care deserts across the U.S. (2022 Report). Available from: https://www.marchofdimes.org/research/maternitycare-deserts-report.aspx. Accessed October 25, 2023.
  • Manuck TA, Esplin MS, Biggio J, et al. The phenotype of spontaneous preterm birth: application of a clinical phenotyping tool. Am J Obstet Gynecol. 2015;212(4):487.e1–487.e11. doi:10.1016/j.ajog.2015.02.010
  • Wadhwa PD, Porto M, Garite TJ, Chicz-DeMet A, Sandman CA. Maternal corticotropin-releasing hormone levels in the early third trimester predict length of gestation in human pregnancy. Am J Obstet Gynecol. 1998;179(4):1079–1085. doi:10.1016/s0002-9378(98)70219-4
  • Holzman C, Jetton J, Siler-Khodr T, Fisher R, Rip T. Second trimester corticotropin-releasing hormone levels in relation to preterm delivery and ethnicity. Obstet Gynecol. 2001;97(5 Pt 1):657–663. doi:10.1016/s0029-7844(00)01209-6
  • Hobel CJ, Dunkel-Schetter C, Roesch SC, Castro LC, Arora CP. Maternal plasma corticotropin-releasing hormone associated with stress at 20 weeks’ gestation in pregnancies ending in preterm delivery. Am J Obstet Gynecol. 1999;180(1 Pt 3):S257–S263. doi:10.1016/s0002-9378(99)70712-x
  • Mancuso RA, Schetter CD, Rini CM, Roesch SC, Hobel CJ. Maternal prenatal anxiety and corticotropin-releasing hormone associated with timing of delivery. Psychosom Med. 2004;66(5):762–769. doi:10.1097/01.psy.0000138284.70670.d5
  • American College of Obstetricians and Gynecologists. Screening for perinatal depression. ACOG Committee Opinion No. 757. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2018;132(5):e208–212. doi:10.1097/AOG.0000000000002927
  • Rodriguez AN, Holcomb D, Fleming E, et al. Improving access to perinatal mental health services: the value of on-site resources. Am J Obstet Gynecol MFM. 2021;3(6):100456. doi:10.1016/j.ajogmf.2021.100456
  • Rice LW, Cedars MI, Sadovsky Y, et al. Increasing NIH funding for academic departments of obstetrics and gynecology: a call to action. Am J Obstet Gynecol. 2020;223(1):79 e1–79 e8. doi:10.1016/j.ajog.2020.03.022
  • NIH Reporter. Fiscal year 2022. Available from: https://reporter.nih.gov/search/fUY0rBAOHUmfky5HZooIlw/projects/charts. Accessed May 18, 2023.