What now? A critical evaluation of over 20 years of clinical and research experience with 17-alpha hydroxyprogesterone caproate for recurrent preterm birth prevention.

17-alpha hydroxyprogesterone caproate personalized medicine preterm birth progestogens

Journal

American journal of obstetrics & gynecology MFM
ISSN: 2589-9333
Titre abrégé: Am J Obstet Gynecol MFM
Pays: United States
ID NLM: 101746609

Informations de publication

Date de publication:
Oct 2023
Historique:
received: 18 05 2023
revised: 08 07 2023
accepted: 14 07 2023
pubmed: 2 8 2023
medline: 2 8 2023
entrez: 1 8 2023
Statut: ppublish

Résumé

Spontaneous preterm birth is multifactorial, and underlying etiologies remain incompletely understood. Supplementation with progestogens, including 17-alpha hydroxyprogesterone caproate has been a mainstay of prematurity prevention strategies in the United States in the last 2 decades. Following a recent negative confirmatory trial, 17-alpha hydroxyprogesterone caproate was withdrawn from the US market and is currently available only through clinical research studies. This expert review summarized clinical and research data regarding the use of 17-alpha hydroxyprogesterone caproate in the United States from 2003 to 2023 for recurrent prematurity prevention. In 17-alpha hydroxyprogesterone caproate. The history of the use, mechanisms of action, clinical trial results, and efficacy by clinical and biologic criteria of 17-alpha hydroxyprogesterone caproate are presented. We report that disparate findings and conclusions between similarly designed rigorous studies may reflect differences in a priori risk and population incidence and extreme care should be taken in interpreting the studies and making decisions regarding efficacy of 17-alpha hydroxyprogesterone caproate for the prevention of preterm birth. The likelihood of improved obstetrical outcomes after receiving 17-alpha hydroxyprogesterone caproate may vary by clinical factors (eg, body mass index), plasma drug concentrations, and genetic factors, although the identification of individuals most likely to benefit remains imperfect. It is crucial for the medical community to recognize the importance of preserving the decades-long efforts invested in preventing recurrent preterm birth in the United States. Moreover, it is important that we thoroughly and thoughtfully evaluate 17-alpha hydroxyprogesterone caproate as a promising contender for future well-executed prematurity studies.

Identifiants

pubmed: 37527737
pii: S2589-9333(23)00250-1
doi: 10.1016/j.ajogmf.2023.101108
pmc: PMC10591827
mid: NIHMS1936465
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

101108

Subventions

Organisme : NIEHS NIH HHS
ID : K24 ES031131
Pays : United States
Organisme : NIMHD NIH HHS
ID : R01 MD011609
Pays : United States

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Références

Obstet Gynecol. 2012 Oct;120(4):964-73
pubmed: 22996126
Natl Vital Stat Rep. 1999 Dec 15;47(29):1-9
pubmed: 10635682
Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1175-80
pubmed: 16157133
Gynecol Endocrinol. 1996 Dec;10(6):421-6
pubmed: 9032570
Am J Obstet Gynecol MFM. 2023 Jul;5(7):100980
pubmed: 37100349
JAMA. 2000 Mar 22-29;283(12):1591-6
pubmed: 10735396
Am J Obstet Gynecol. 2016 Mar;214(3):306-7
pubmed: 26928145
Am J Obstet Gynecol. 2012 May;206(5):376-86
pubmed: 22542113
Am J Obstet Gynecol. 2017 Jun;216(6):600.e1-600.e9
pubmed: 28223163
Pediatrics. 2008 Nov;122(5):e1014-21
pubmed: 18977951
Egypt J Immunol. 2023 Apr;30(2):109-118
pubmed: 37031413
Am J Obstet Gynecol. 2012 Nov;207(5):396.e1-8
pubmed: 22959763
Clin Perinatol. 2013 Dec;40(4):739-51
pubmed: 24182959
Am J Obstet Gynecol. 2008 Oct;199(4):391.e1-7
pubmed: 18928984
J Matern Fetal Neonatal Med. 2012 Jul;25(7):1034-8
pubmed: 21854134
Am J Perinatol. 2018 Jul;35(8):721-728
pubmed: 29241278
Obstet Gynecol. 2007 Oct;110(4):865-72
pubmed: 17906021
Am J Obstet Gynecol. 2017 Sep;217(3):371.e1-371.e7
pubmed: 28526452
Am J Obstet Gynecol. 2011 Jul;205(1):40.e1-8
pubmed: 21620357
Am J Obstet Gynecol. 2014 Apr;210(4):321.e1-321.e21
pubmed: 24594138
Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8
pubmed: 19788970
Lancet. 2021 Mar 27;397(10280):1183-1194
pubmed: 33773630
Am J Obstet Gynecol. 2008 Jan;198(1):119.e1-4
pubmed: 17936235
Obstet Gynecol. 2007 Aug;110(2 Pt 1):405-15
pubmed: 17666618
Am J Obstet Gynecol. 2016 Nov;215(5):622.e1-622.e8
pubmed: 27418444
Reprod Biol Endocrinol. 2004 Dec 07;2:80
pubmed: 15585068
Am J Perinatol. 2009 Aug;26(7):529-36
pubmed: 19301227
Cochrane Database Syst Rev. 2013 Jul 31;(7):CD004947
pubmed: 23903965
Pediatrics. 2007 Jul;120(1):e1-9
pubmed: 17606536
Am J Obstet Gynecol. 2022 Jan;226(1):132.e1-132.e14
pubmed: 34767803
Am J Obstet Gynecol. 2013 Jun;208(6):421-6
pubmed: 23643669
PLoS One. 2018 Dec 31;13(12):e0209346
pubmed: 30596707
Ann N Y Acad Sci. 1997 Sep 26;828:291-9
pubmed: 9329850
N Engl J Med. 2003 Jun 12;348(24):2379-85
pubmed: 12802023
Nat Genet. 2001 Apr;27(4):383-91
pubmed: 11279519
Am J Obstet Gynecol. 2011 Sep;205(3):275.e1-5
pubmed: 22071063
Am J Obstet Gynecol. 2015 Dec;213(6):844.e1-6
pubmed: 26275354
Br J Clin Pharmacol. 2016 Oct;82(4):1084-93
pubmed: 27133963
Am J Obstet Gynecol. 2013 Mar;208(3):223.e1-7
pubmed: 23433326
Obstet Gynecol. 2003 Nov;102(5 Pt 1):1115-6
pubmed: 14672496
Am J Obstet Gynecol. 2016 Mar;214(3):376.e1-8
pubmed: 26692181
Epigenomics. 2021 May;13(9):667-682
pubmed: 33890487
Anesth Analg. 2015 May;120(5):1085-1094
pubmed: 25806402
Br J Obstet Gynaecol. 1990 Feb;97(2):149-54
pubmed: 2138496
Am J Obstet Gynecol. 2017 Mar;216(3):B11-B13
pubmed: 28126367
Am J Obstet Gynecol. 2012 Feb;206(2):108-12
pubmed: 22118964
Am J Obstet Gynecol. 2006 Oct;195(4):1004-10
pubmed: 17000233
Obstet Gynecol. 2020 Sep;136(3):622-627
pubmed: 32769653
Acta Obstet Gynecol Scand. 2016 Dec;95(12):1383-1390
pubmed: 27663202
Am J Obstet Gynecol. 2011 Aug;205(2):135.e1-9
pubmed: 21600550
Am J Obstet Gynecol. 2012 Nov;207(5):390.e1-8
pubmed: 23010094
Ann N Y Acad Sci. 1997 Sep 26;828:285-90
pubmed: 9329849
Am J Obstet Gynecol. 2013 Mar;208(3):194.e1-8
pubmed: 23433324
Reprod Sci. 2009 Nov;16(11):1052-61
pubmed: 19602723
Am J Obstet Gynecol. 2010 Aug;203(2):89-100
pubmed: 20417491
Trends Endocrinol Metab. 2003 Mar;14(2):54-6
pubmed: 12591170
Am J Obstet Gynecol. 2014 May;210(5):426.e1-9
pubmed: 24793722
Obstet Gynecol. 2001 Sep;98(3):379-85
pubmed: 11530116
N Engl J Med. 2020 Dec 10;383(24):e131
pubmed: 33140923
Am J Obstet Gynecol. 2015 Dec;213(6):846.e1-846.e19
pubmed: 26264823
Am J Obstet Gynecol. 2015 Aug;213(2):233.e1-5
pubmed: 25912300
Am J Obstet Gynecol. 2014 Feb;210(2):128.e1-6
pubmed: 24113254
Am J Obstet Gynecol. 2014 Aug;211(2):158.e1-6
pubmed: 24548847
Am J Obstet Gynecol. 2017 Sep;217(3):369.e1-369.e9
pubmed: 28522317
Am J Obstet Gynecol. 1979 Dec 15;135(8):1086-103
pubmed: 517593
Obstet Gynecol. 1993 Mar;81(3):444-6
pubmed: 8437803
Reprod Sci. 2015 Dec;22(12):1577-86
pubmed: 26037300
BJOG. 2018 Feb;125(3):343-350
pubmed: 28139890
Obstet Gynecol. 1995 Nov;86(5):800-4
pubmed: 7566852
Am J Obstet Gynecol. 2013 Sep;209(3):269.e1-7
pubmed: 23747451
Am J Obstet Gynecol. 2009 Oct;201(4):410.e1-5
pubmed: 19716117
Reprod Sci. 2010 Jun;17(6):532-9
pubmed: 20360593
Am J Obstet Gynecol. 2010 Apr;202(4):351.e1-6
pubmed: 20350641
Obstet Gynecol. 2010 Apr;115(4):765-770
pubmed: 20308837
Am J Perinatol. 2016 Feb;33(3):305-17
pubmed: 26788789
Am J Obstet Gynecol. 2010 Dec;203(6):561.e1-5
pubmed: 20810098
J Soc Gynecol Investig. 2002 May-Jun;9(3):125-36
pubmed: 12009386
Am J Obstet Gynecol. 2012 Nov;207(5):398.e1-8
pubmed: 22967833
Am J Obstet Gynecol. 2015 Aug;213(2):175-80
pubmed: 25511243
BJOG. 2016 Feb;123(3):368-75
pubmed: 26542879
JAMA. 2015 Sep 8;314(10):1039-51
pubmed: 26348753
J Perinat Med. 2005;33(6):506-9
pubmed: 16318612
J Obes. 2014;2014:563243
pubmed: 25405027
Am J Obstet Gynecol. 2016 Jul;215(1):103.e1-103.e14
pubmed: 26772790
Am J Obstet Gynecol. 2006 Sep;195(3):643-50
pubmed: 16949395
Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1156-60
pubmed: 16157129
Am J Obstet Gynecol. 2010 Sep;203(3):257.e1-5
pubmed: 20678745
Drug Metab Dispos. 2015 Aug;43(8):1286-93
pubmed: 25979262
Am J Perinatol. 2020 Jan;37(2):127-136
pubmed: 31652479
Lancet. 2013 Jan 19;381(9862):223-34
pubmed: 23158883

Auteurs

Tracy A Manuck (TA)

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC (Dr Manuck); Institute for Environmental Health Solutions, Gillings School of Global Public Health, Chapel Hill, NC (Dr Manuck). Electronic address: tmanuck@med.unc.edu.

Cynthia Gyamfi-Bannerman (C)

Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, San Diego, CA (Dr Gyamfi-Bannerman).

George Saade (G)

Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA (Dr Saade).

Classifications MeSH