153
Views
6
CrossRef citations to date
0
Altmetric
Original Research

Cost-Effectiveness of a Proteomic Test for Preterm Birth Prediction

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon & show all
Pages 809-820 | Published online: 14 Sep 2021

References

  • Barradas DT, Wasserman MP, Daniel-Robinson L, et al. Hospital utilization and costs among preterm infants by payer: Nationwide Inpatient Sample, 2009. Matern Child Health J. 2016;20(4):808–818. doi:10.1007/s10995-015-1911-y
  • Phibbs CS, Schmitt SK, Cooper M, et al. Birth hospitalization costs and days of care for mothers and neonates in California, 2009–2011. J Pediatr. 2019;204:118–125.e114. doi:10.1016/j.jpeds.2018.08.041
  • Beam AL, Fried I, Palmer N, et al. Estimates of healthcare spending for preterm and low-birthweight infants in a commercially insured population: 2008–2016. J Perinatol. 2020;40(7):1091–1099. doi:10.1038/s41372-020-0635-z
  • Hamilton BE, Martin JA, Osterman MJK. Births: provisional data for 2020. Vital Statistics Rapid Release; no.12. Hyattsville, MD: National Center for Health Statistics; May 2021. Available from: https://www.cdc.gov/nchs/data/vsrr/vsrr012-508.pdf. Accessed June 2, 2021.
  • 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
  • Behrman RE, Butler AS. Institutes of Medicine. In: Societal Costs of Preterm Birth. Washington, DC: National Academies Press (US); 2007.
  • Petrou S, Yiu HH, Kwon J. Economic consequences of preterm birth: a systematic review of the recent literature (2009–2017). Arch Dis Child. 2019;104(5):456–465. doi:10.1136/archdischild-2018-315778
  • Manuck TA, Rice MM, Bailit JL, et al. Preterm neonatal morbidity and mortality by gestational age: a contemporary cohort. Am J Obstet Gynecol. 2016;215(1):103.e1–103.e14. doi:10.1016/j.ajog.2016.01.004
  • Ananth CV, Vintzileos AM. Epidemiology of preterm birth and its clinical subtypes. J Matern Fetal Neonatal Med. 2006;19(12):773–782. doi:10.1080/14767050600965882
  • Romero R, Dey SK, Fisher SJ. Preterm labor: One syndrome, many causes. Science. 2014;345(6198):760–765. doi:10.1126/science.1251816
  • Laughon SK, Albert PS, Leishear K, Mendola P. The NICHD Consecutive Pregnancies Study: recurrent preterm delivery by subtype. Am J Obstet Gynecol. 2014;210(2):131.e1–131.e8. doi:10.1016/j.ajog.2013.09.014
  • Esplin MS, Elovitz MA, Iams JD, et al. Predictive accuracy of serial transvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women. JAMA. 2017;317(10):1047–1056. doi:10.1001/jama.2017.1373
  • Iams JD, Solomon CG. Clinical practice. Prevention of preterm parturition. N Engl J Med. 2014;370(3):254–261. doi:10.1056/NEJMcp1103640
  • Saade GR, Boggess KA, Sullivan SA, et al. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016;214(5):633.e1–633.e24. doi:10.1016/j.ajog.2016.02.001
  • Markenson GR, Saade GR, Laurent LC, et al. Performance of a proteomic preterm delivery predictor in a large independent prospective cohort. Am J Obstet Gynecol MFM. 2020;2(3):100140. doi:10.1016/j.ajogmf.2020.100140
  • Society for Maternal-Fetal Medicine Publications Committee. Progesterone and preterm birth prevention: Translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376–386. doi:10.1016/j.ajog.2012.03.010
  • Hillemeier MM, Domino ME, Wells R, et al. Effects of maternity care coordination on pregnancy outcomes: Propensity-weighted analyses. Matern Child Health J. 2015;19(1):121–127. doi:10.1007/s10995-014-1502-3
  • Newman RB, Sullivan SA, Menard MK, et al. South Carolina Partners for Preterm Birth Prevention: a regional perinatal initiative for the reduction of premature birth in a Medicaid population. Am J Obstet Gynecol. 2008;199(4):393.e1–393.e8. doi:10.1016/j.ajog.2008.07.047
  • Caughey AB, Zupancic JA, Greenberg JM, Garfield SS, Thung SF, Iams JD. Clinical and cost impact analysis of a novel prognostic test for early detection of preterm birth. AJP Rep. 2016;6(4):e407–e416. doi:10.1055/s-0036-1593866
  • Siebert U, Alagoz O, Bayoumi AM, et al. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force–3. Value Health. 2012;15(6):812–820. doi:10.1016/j.jval.2012.06.014
  • 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
  • Manuck TA, Henry E, Gibson J, et al. Pregnancy outcomes in a recurrent preterm birth prevention clinic. Am J Obstet Gynecol. 2011;204(4):320.e1–320.e6. doi:10.1016/j.ajog.2011.01.011
  • 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.e1–390.e8. doi:10.1016/j.ajog.2012.09.013
  • 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
  • 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(2):127–136. doi:10.1055/s-0039-3400227
  • Branch DW, Esplin MS, Porter F, et al. Prediction and Prevention of Preterm Birth: A prospective, randomized intervention trial. Society for Reproductive Investigation; 2020:abstract LBA–003.
  • Branch DW, VanBuren JM, Porter TF, et al. Prediction and Prevention of Preterm Birth: A prospective, randomized intervention trial. Am J Perinatol. Epub 2021 Aug 16. doi:10.1055/s-0041-1732339
  • ClinicalTrials.gov. National Library of Medicine. Prematurity risk assessment combined with clinical interventions for improving neonatal outcomes (PRIME). Identifier NCT04301518; March 2020. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04301518. Accessed June 2, 2021.
  • ClinicalTrials.gov. National Library of Medicine. Serum assessment of preterm birth outcomes compared to historical controls: AVERT PRETERM TRIAL. Identifier NCT03151330; May 2017. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03151330. Accessed June 2, 2021.
  • Bureau of Labor Statistics. United States department of labor; 2020. Available from: http://data.bls.gov/cgi-bin/srgateseries_id=CUUR0000SAM, (Consumer Price Index medical care component). Accessed June 2, 2021.
  • 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
  • Office of Disease Prevention and Health Promotion, US Department of Health And Human Services. Healthy People 2020: Leading Health Indicators. Available from: https://www.healthypeople.gov/2020/Leading-Health-Indicators. Accessed June 2, 2021.
  • Glover AV, Manuck TA. Screening for spontaneous preterm birth and resultant therapies to reduce neonatal morbidity and mortality: A review. Semin Fetal Neonatal Med. 2018;23(2):126–132. doi:10.1016/j.siny.2017.11.007
  • Varley-Campbell J, Mújica-Mota R, Coelho H, et al. Three biomarker tests to help diagnose preterm labour: a systematic review and economic evaluation. Health Technol Assess. 2019;23(13):1–226. doi:10.3310/hta23130
  • Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: final data for 2018. Natl Vital Stat Rep. 2019;68(13):1–47.
  • Boniface JJ, Burchard J, Saade GR. Effects of selective exclusion of patients on preterm birth test performance. Obstet Gynecol. 2019;134(6):1333–1338. doi:10.1097/AOG.0000000000003511
  • Pizzi LT, Seligman NS, Baxter JK, Jutkowitz E, Berghella V. Cost and cost effectiveness of vaginal progesterone gel in reducing preterm birth: an economic analysis of the PREGNANT trial. Pharmacoeconomics. 2014;32(5):467–478. doi:10.1007/s40273-014-0133-2
  • Truven Health Analytics. The cost of having a baby in the United States. In: Truven Health Analytics MarketScan® Study. 2013. Available from: https://www.nationalpartnership.org/our-work/resources/health-care/maternity/archive/the-cost-of-having-a-baby-in-the-us.pdf.  Accessed June 2, 2021.
  • Forbes K, Westwood M. Maternal growth factor regulation of human placental development and fetal growth. J Endocrinol. 2010;207(1):1–16. doi:10.1677/JOE-10-0174
  • Crosley EJ, Dunk CE, Beristain AG, Christians JK. IGFBP-4 and −5 are expressed in first-trimester villi and differentially regulate the migration of HTR-8/SVneo cells. Reprod Biol Endocrinol. 2014;12(1):123. doi:10.1186/1477-7827-12-123
  • Qiu Q, Bell M, Lu X, et al. Significance of IGFBP-4 in the development of fetal growth restriction. J Clin Endocrinol Metab. 2012;97(8):E1429–1439. doi:10.1210/jc.2011-2511
  • Larrea F, Díaz L, Cariño C, et al. Evidence that human placenta is a site of sex hormone-binding globulin gene expression. J Steroid Biochem Mol Biol. 1993;46(4):497–505. doi:10.1016/0960-0760(93)90104-5
  • Hammond GL. Diverse roles for sex hormone-binding globulin in reproduction. Biol Reprod. 2011;85(3):431–441. doi:10.1095/biolreprod.111.092593
  • Simó R, Sáez-López C, Barbosa-Desongles A, Hernández C, Selva DM. Novel insights in SHBG regulation and clinical implications. Trends Endocrinol Metab. 2015;26(7):376–383. doi:10.1016/j.tem.2015.05.001
  • Bensimon A, Heck AJ, Aebersold R. Mass spectrometry-based proteomics and network biology. Annu Rev Biochem. 2012;81(1):379–405. doi:10.1146/annurev-biochem-072909-100424
  • Stout MJ, Busam R, Macones GA, Tuuli MG. Spontaneous and indicated preterm birth subtypes: interobserver agreement and accuracy of classification. Am J Obstet Gynecol. 2014;211(5):530.e531–530.e534. doi:10.1016/j.ajog.2014.05.023
  • Barton JR, Istwan NB, Rhea D, Collins A, Stanziano GJ. Cost-savings analysis of an outpatient management program for women with pregnancy-related hypertensive conditions. Dis Manag. 2006;9(4):236–241. doi:10.1089/dis.2006.9.236
  • Seegmiller RE, Nelson GW, Johnson CK. Evaluation of the teratogenic potential of delalutin (17 alpha-hydroxyprogesterone caproate) in mice. Teratology. 1983;28(2):201–208. doi:10.1002/tera.1420280208
  • Christian MS, Brent RL, Calda P. Embryo-fetal toxicity signals for 17alpha-hydroxyprogesterone caproate in high-risk pregnancies: a review of the non-clinical literature for embryo-fetal toxicity with progestins. J Matern Fetal Neonatal Med. 2007;20(2):89–112. doi:10.1080/14767050601178758
  • McNamara HC, Wood R, Chalmers J, et al. STOPPIT Baby Follow-up Study: the effect of prophylactic progesterone in twin pregnancy on childhood outcome. PLoS One. 2015;10(4):e0122341. doi:10.1371/journal.pone.0122341
  • 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
  • Northen AT, Norman GS, Anderson K, et al. Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110(4):865–872. doi:10.1097/01.AOG.0000281348.51499.bc
  • Food and Drug Administration. CDER proposes withdrawal of approval for Makena; 2020. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/cder-proposes-withdrawal-approval-makena. Accessed June 2, 2021.
  • Crump C, Sundquist J, Howell EA, McLaughlin MA, Stroustrup A, Sundquist K. Pre-term delivery and risk of ischemic heart disease in women. J Am Coll Cardiol. 2020;76(1):57–67. doi:10.1016/j.jacc.2020.04.072
  • Crump C. Adult mortality after preterm birth-time to translate findings into clinical practice. JAMA Netw Open. 2021;4(1):e2033361. doi:10.1001/jamanetworkopen.2020.33361
  • Raju TNK, Pemberton VL, Saigal S, Blaisdell CJ, Moxey-Mims M, Buist S. Long-term healthcare outcomes of preterm birth: an executive summary of a conference sponsored by the National Institutes of Health. J Pediatr. 2017;181:309–318.e1. doi:10.1016/j.jpeds.2016.10.015
  • Wu P, Gulati M, Kwok CS, et al. Preterm delivery and future risk of maternal cardiovascular disease: a systematic review and meta-analysis. J Am Heart Assoc. 2018;7(2):e007809. doi:10.1161/JAHA.117.007809