Reassessing Preterm Birth Prevention After the Withdrawal of 17-α Hydroxyprogesterone Caproate.
Journal
Obstetrics and gynecology
ISSN: 1873-233X
Titre abrégé: Obstet Gynecol
Pays: United States
ID NLM: 0401101
Informations de publication
Date de publication:
01 09 2023
01 09 2023
Historique:
received:
20
04
2023
accepted:
01
06
2023
medline:
21
8
2023
pubmed:
13
7
2023
entrez:
13
7
2023
Statut:
ppublish
Résumé
The U.S. Food and Drug Administration has recently withdrawn approval for 17-α hydroxyprogesterone caproate for prevention of recurrent preterm birth, and recent studies have called into question benefits of the pessary in the setting of a short cervix. Obstetric health care professionals are once again left with limited remaining options for preterm birth prevention. This narrative review summarizes the best current evidence on the use of vaginal progesterone, low-dose aspirin, and cerclage for the prevention of preterm birth; attempts to distill possible lessons learned from studies of progesterone and pessary, as well as their implementation into practice; and highlights areas where inroads into preterm birth prevention may be possible outside of the progesterone-aspirin-cerclage paradigm.
Identifiants
pubmed: 37441790
doi: 10.1097/AOG.0000000000005290
pii: 00006250-990000000-00820
doi:
Substances chimiques
17 alpha-Hydroxyprogesterone Caproate
276F2O42F5
Progesterone
4G7DS2Q64Y
Types de publication
Review
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
493-501Informations de copyright
Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Financial Disclosure The author did not report any potential conflicts of interest.
Références
U.S. Food and Drug Administration. Makena (hydroxyprogesterone caproate) injection information. Accessed May 23, 2003. https://fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information
Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003;348:2379–85. doi: 10.1056/NEJMoa035140
doi: 10.1056/NEJMoa035140
Blackwell SC, Gyamfi-Bannerman C, Biggio JR Jr, Chauhan SP, Hughes BL, Louis JM, 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;37:127–36. doi: 10.1055/s-0039-3400227
doi: 10.1055/s-0039-3400227
American College of Obstetricians and Gynecologists. Updated clinical guidance for the use of progesterone supplementation for the prevention of recurrent preterm birth. Accessed May 23, 2003. https://acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/04/updated-guidance-use-of-progesterone-supplementation-for-prevention-of-recurrent-preterm-birth
Society for Maternal-Fetal Medicine.SMFM special statement: response to the Food and Drug Administration's withdrawal of 17-alpha hydroxyprogesterone caproate. Accessed May 23, 2003. https://smfm.org/publications/467-smfm-special-statement-response-to-the-food-and-drug-administrations-withdrawal-of-17-alpha-hydroxyprogesterone-caproate
Spong CY. Prediction and prevention of recurrent spontaneous preterm birth. Obstet Gynecol 2007;110:405–15. doi: 10.1097/01.AOG.0000275287.08520.4a
doi: 10.1097/01.AOG.0000275287.08520.4a
Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, et al. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet 2012;379:1800–6. doi: 10.1016/S0140-6736(12)60030-0
doi: 10.1016/S0140-6736(12)60030-0
Care A, Nevitt SJ, Medley N, Donegan S, Good L, Hampson L, et al. Interventions to prevent spontaneous preterm birth in women with singleton pregnancy who are at high risk: systematic review and network meta-analysis. BMJ 2022;376:e064547. doi: 10.1136/bmj-2021-064547
doi: 10.1136/bmj-2021-064547
Conde-Agudelo A, Romero R, Nicolaides KH. Cervical pessary to prevent preterm birth in asymptomatic high-risk women: a systematic review and meta-analysis. Am J Obstet Gynecol 2020;223:42–65. doi: 10.1016/j.ajog.2019.12.266
doi: 10.1016/j.ajog.2019.12.266
D'Antonio F, Berghella V, Di Mascio D, Saccone G, Sileo F, Flacco ME, et al. Role of progesterone, cerclage and pessary in preventing preterm birth in twin pregnancies: a systematic review and network meta-analysis. Eur J Obstet Gynecol Reprod Biol 2021;261:166–77. doi: 10.1016/j.ejogrb.2021.04.023
doi: 10.1016/j.ejogrb.2021.04.023
Jarde A, Lutsiv O, Beyene J, McDonald SD. Vaginal progesterone, oral progesterone, 17-OHPC, cerclage, and pessary for preventing preterm birth in at-risk singleton pregnancies: an updated systematic review and network meta-analysis. BJOG 2019;126:556–67. doi: 10.1111/1471-0528.15566
doi: 10.1111/1471-0528.15566
Norman JE, Norrie J, MacLennan G, Cooper D, Whyte S, Chowdhry S, et al. The Arabin pessary to prevent preterm birth in women with a twin pregnancy and a short cervix: the STOPPIT 2 RCT. Health Technol Assess 2021;25:1–66. doi: 10.3310/hta25440
doi: 10.3310/hta25440
Hoffman M. Randomized trial of cervical pessary for short cervix in singleton pregnancies. Am J Obstet Gynecol 2023;228:S5–6. doi: 10.1016/j.ajog.2022.11.009
doi: 10.1016/j.ajog.2022.11.009
Prediction and prevention of spontaneous preterm birth. ACOG Practice Bulletin No. 234. American College of Obstetricians and Gynecologists. Obstet Gynecol 2021;138:e65–90. doi: 10.1097/AOG.0000000000004479
doi: 10.1097/AOG.0000000000004479
Romero R, Stanczyk FZ. Progesterone is not the same as 17α-hydroxyprogesterone caproate: implications for obstetrical practice. Am J Obstet Gynecol 2013;208:421–6. doi: 10.1016/j.ajog.2013.04.027
doi: 10.1016/j.ajog.2013.04.027
Furcron AE, Romero R, Plazyo O, Unkel R, Xu Y, Hassan SS, et al. Vaginal progesterone, but not 17α-hydroxyprogesterone caproate, has antiinflammatory effects at the murine maternal-fetal interface. Am J Obstet Gynecol 2015;213:846.e1–19. doi: 10.1016/j.ajog.2015.08.010
doi: 10.1016/j.ajog.2015.08.010
Conde-Agudelo A, Romero R. Vaginal progesterone does not prevent recurrent preterm birth in women with a singleton gestation, a history of spontaneous preterm birth, and a midtrimester cervical length >25 mm. Am J Obstet Gynecol 2022;227:923–6. doi: 10.1016/j.ajog.2022.07.054
doi: 10.1016/j.ajog.2022.07.054
Conde-Agudelo A, Romero R. Vaginal progesterone for the prevention of preterm birth: who can benefit and who cannot? Evidence-based recommendations for clinical use. J Perinatal Med 2023;51:125–34. doi: 10.1515/jpm-2022-0462
doi: 10.1515/jpm-2022-0462
Phung J, Williams KP, McAullife L, Martin WN, Flint C, Andrew B, et al. Vaginal progesterone for prevention of preterm birth in asymptomatic high-risk women with a normal cervical length: a systematic review and meta-analysis. J Matern Fetal Neonatal Med 2022;35:7093–101. doi: 10.1080/14767058.2021.1943657
doi: 10.1080/14767058.2021.1943657
Conde-Agudelo A, Romero R, Da Fonseca E, O'Brien JM, Cetingoz E, Creasy GW, et al. Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: updated indirect comparison meta-analysis. Am J Obstet Gynecol 2018;219:10–25. doi: 10.1016/j.ajog.2018.03.028
doi: 10.1016/j.ajog.2018.03.028
Stewart LA, Simmonds M, Duley L, Llewellyn A, Sharif S, Walker RA, et al. Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials. Lancet 2021;397:1183–94. doi: 10.1016/S0140-6736(21)00217-8
doi: 10.1016/S0140-6736(21)00217-8
Norman JE, Marlow N, Messow CM, Shennan A, Bennett PR, Thornton S, et al. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet 2016;387:2106–16. doi: 10.1016/S0140-6736(16)00350-0
doi: 10.1016/S0140-6736(16)00350-0
Romero R, Conde-Agudelo A, Da Fonseca E, O'Brien JM, Cetingoz E, Creasy GW, 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;218:161–80. doi: 10.1016/j.ajog.2017.11.576
doi: 10.1016/j.ajog.2017.11.576
Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol 2012;206:124.e1–19. doi: 10.1016/j.ajog.2011.12.003
doi: 10.1016/j.ajog.2011.12.003
Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, et al. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol 2017;50:569–77. doi: 10.1002/uog.17457
doi: 10.1002/uog.17457
Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol 2011;117:663–71. doi: 10.1097/AOG.0b013e31820ca847
doi: 10.1097/AOG.0b013e31820ca847
Loftin RW, Habli M, Snyder CC, Cormier CM, Lewis DF, Defranco EA. Late preterm birth. Rev Obstet Gynecol 2010;3:10–9.
Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, et al. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol 2009;201:375.e1–8. doi: 10.1016/j.ajog.2009.08.015
doi: 10.1016/j.ajog.2009.08.015
Enakpene CA, DiGiovanni L, Jones TN, Marshalla M, Mastrogiannis D, Della Torre M. Cervical cerclage for singleton pregnant patients on vaginal progesterone with progressive cervical shortening. Am J Obstet Gynecol 2018;219:397.e1–10. doi: 10.1016/j.ajog.2018.06.020
doi: 10.1016/j.ajog.2018.06.020
Shor S, Zimerman A, Maymon R, Kovo M, Wolf M, Wiener I, et al. Combined therapy with vaginal progesterone, Arabin cervical pessary and cervical cerclage to prevent preterm delivery in high-risk women. J Matern Fetal Neonatal Med 2021;34:2154–8. doi: 10.1080/14767058.2019.1659771
doi: 10.1080/14767058.2019.1659771
Tolosa JE, Boelig RC, Bell J, Martinez-Baladejo MT, Stoltzfus J, Cruz Y, et al. Progesterone and cerclage reduce prematurity. the International Collaborative for Cerclage Longitudinal Evaluation and Research (IC-CLEAR). Am J Obstet Gynecol 2023;228:S22–3. doi: 10.1016/j.ajog.2022.11.031
doi: 10.1016/j.ajog.2022.11.031
Multifetal gestations: twin, triplet, and higher-order multifetal pregnancies: ACOG Practice Bulletin No. 231. American College of Obstetricians and Gynecologists. Obstet Gynecol 2021;137:e145–62. doi: 10.1097/AOG.0000000000004397
doi: 10.1097/AOG.0000000000004397
Saccone G, Rust O, Althuisius S, Roman A, Berghella V. Cerclage for short cervix in twin pregnancies: systematic review and meta-analysis of randomized trials using individual patient-level data. Acta Obstet Gynecol Scand 2015;94:352–8. doi: 10.1111/aogs.12600
doi: 10.1111/aogs.12600
Roman A, Rochelson B, Fox NS, Hoffman M, Berghella V, Patel V, et al. Efficacy of ultrasound-indicated cerclage in twin pregnancies. Am J Obstet Gynecol 2015;212:788.e1–6. doi: 10.1016/j.ajog.2015.01.031
doi: 10.1016/j.ajog.2015.01.031
Romero R, Conde-Agudelo A, Rehal A, Da Fonseca E, Brizot ML, Rode L, et al. Vaginal progesterone for the prevention of preterm birth and adverse perinatal outcomes in twin gestations with a short cervix: an updated individual patient data meta-analysis. Ultrasound Obstet Gynecol 2022;59:263–6. doi: 10.1002/uog.24839
doi: 10.1002/uog.24839
Berghella V, Mackeen AD. Cervical length screening with ultrasound-indicated cerclage compared with history-indicated cerclage for prevention of preterm birth: a meta-analysis. Obstet Gynecol 2011;118:148–55. doi: 10.1097/AOG.0b013e31821fd5b0
doi: 10.1097/AOG.0b013e31821fd5b0
Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, et al. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial. Lancet 2020;395:285–93. doi: 10.1016/S0140-6736(19)32973-3
doi: 10.1016/S0140-6736(19)32973-3
Silver RM, Ahrens K, Wong LF, Perkins NJ, Galai N, Lesher LL, et al. Low-dose aspirin and preterm birth: a randomized controlled trial. Obstet Gynecol 2015;125:876–84. doi: 10.1097/AOG.0000000000000736
doi: 10.1097/AOG.0000000000000736
Andrikopoulou M, Purisch SE, Handal-Orefice R, Gyamfi-Bannerman C. Low-dose aspirin is associated with reduced spontaneous preterm birth in nulliparous women. Am J Obstet Gynecol 2018;219:399.e1–6. doi: 10.1016/j.ajog.2018.06.011
doi: 10.1016/j.ajog.2018.06.011
Ayala NK, Rouse DJ. A nudge toward universal aspirin for preeclampsia prevention. Obstet Gynecol 2019;133:725–8. doi: 10.1097/AOG.0000000000003167
doi: 10.1097/AOG.0000000000003167
Van Doorn R, Mukhtarova N, Flyke IP, Lasarev M, Kim K, Hennekens CH, et al. Dose of aspirin to prevent preterm preeclampsia in women with moderate or high-risk factors: a systematic review and meta-analysis. PLoS One 2021;16:e0247782. doi: 10.1371/journal.pone.0247782
doi: 10.1371/journal.pone.0247782
Tita AT, Szychowski JM, Boggess K, Dugoff L, Sibai B, Lawrence K, et al. Treatment for mild chronic hypertension during pregnancy. N Engl J Med 2022;386:1781–92. doi: 10.1056/NEJMoa2201295
doi: 10.1056/NEJMoa2201295
Romero R, Espinoza J, Kusanovic JP, Gotsch F, Hassan S, Erez O, et al. The preterm parturition syndrome. BJOG 2006;113(suppl 3):17–42. doi: 10.1111/j.1471-0528.2006.01120.x
doi: 10.1111/j.1471-0528.2006.01120.x
Society for Maternal-Fetal Medicine (SMFM) Publications Committee.SMFM statement: use of 17-alpha hydroxyprogesterone caproate for prevention of recurrent preterm birth. Am J Obstet Gynecol 2020;223:B16–8. doi: 10.1016/j.ajog.2020.04.001
doi: 10.1016/j.ajog.2020.04.001
Heyborne KD. 17-alpha hydroxyprogesterone caproate for the prevention of recurrent preterm birth: one size may not fit all. Obstet Gynecol 2016;128:899–903. doi: 10.1097/AOG.0000000000001618
doi: 10.1097/AOG.0000000000001618
Rolnik DL, Nicolaides KH, Poon LC. Prevention of preeclampsia with aspirin. Am J Obstet Gynecol 2022;226:S1108–19. doi: 10.1016/j.ajog.2020.08.045
doi: 10.1016/j.ajog.2020.08.045
Fiore MC, Jaen CR. A clinical blueprint to accelerate the elimination of tobacco use. JAMA 2008;299:2083–5. doi: 10.1001/jama.299.17.2083
doi: 10.1001/jama.299.17.2083
Been JV, Nurmatov UB, Cox B, Nawrot TS, van Schayck CP, Sheikh A. Effect of smoke-free legislation on perinatal and child health: a systematic review and meta-analysis. Lancet 2014;383:1549–60. doi: 10.1016/S0140-6736(14)60082-9
doi: 10.1016/S0140-6736(14)60082-9
El-Mohandes AA, Kiely M, Blake SM, Gantz MG, El-Khorazaty MN. An intervention to reduce environmental tobacco smoke exposure improves pregnancy outcomes. Pediatrics 2010;125:721–8. doi: 10.1542/peds.2009-1809
doi: 10.1542/peds.2009-1809
Vogt F, Hall S, Marteau TM. General practitioners' beliefs about effectiveness and intentions to prescribe smoking cessation medications: qualitative and quantitative studies. BMC Public Health 2006;6:277. doi: 10.1186/1471-2458-6-277
doi: 10.1186/1471-2458-6-277
Middleton P, Gomersall JC, Gould JF, Shepherd E, Olsen SF, Makrides M. Omega-3 fatty acid addition during pregnancy. The Cochrane Database of Systematic Reviews 2018, Issue 11. Art. No.: CD003402. doi: 10.1002/14651858.CD003402.pub3
doi: 10.1002/14651858.CD003402.pub3
Mosaad E, Peiris HN, Holland O, Morean Garcia I, Mitchell MD. The role(s) of eicosanoids and exosomes in human parturition. Front Physiol 2020;11:594313. doi: 10.3389/fphys.2020.594313
doi: 10.3389/fphys.2020.594313
Orr ST, Miller CA, James SA, Babones S. Unintended pregnancy and preterm birth. Paediatr Perinat Epidemiol 2000;14:309–13. doi: 10.1046/j.1365-3016.2000.00289.x
doi: 10.1046/j.1365-3016.2000.00289.x
Schummers L, Hutcheon JA, Hernandez-Diaz S, Williams PL, Hacker MR, VanderWeele TJ, et al. Association of short interpregnancy interval with pregnancy outcomes according to maternal age. JAMA Intern Med 2018;178:1661–70. doi: 10.1001/jamainternmed.2018.4696
doi: 10.1001/jamainternmed.2018.4696
da Silva AA, Simoes VM, Barbieri MA, Bettiol H, Lamy-Filho F, Coimbra LC, et al. Young maternal age and preterm birth. Paediatr Perinat Epidemiol 2003;17:332–9. doi: 10.1046/j.1365-3016.2003.00515.x
doi: 10.1046/j.1365-3016.2003.00515.x
Mark NDE, Wu LL. More comprehensive sex education reduced teen births: quasi-experimental evidence. Proc Natl Acad Sci U S A 2022;119:e2113144119. doi: 10.1073/pnas.2113144119
doi: 10.1073/pnas.2113144119
Han L, Teal SB, Sheeder J, Tocce K. Preventing repeat pregnancy in adolescents: is immediate postpartum insertion of the contraceptive implant cost effective? Am J Obstet Gynecol 2014;211:24.e1–7. doi: 10.1016/j.ajog.2014.03.015
doi: 10.1016/j.ajog.2014.03.015
Premji SS, Pana GS, Cuncannon A, Ronksley PE, Dosani A, Hayden KA, et al. Prenatal allostatic load and preterm birth: a systematic review. Front Psychol 2022;13:1004073. doi: 10.3389/fpsyg.2022.1004073
doi: 10.3389/fpsyg.2022.1004073
DiTosto JD, Holder K, Soyemi E, Beestrum M, Yee LM. Housing instability and adverse perinatal outcomes: a systematic review. Am J Obstet Gynecol MFM 2021;3:100477. doi: 10.1016/j.ajogmf.2021.100477
doi: 10.1016/j.ajogmf.2021.100477
Hardcastle K, Ford K, Bellis MA. Maternal adverse childhood experiences and their association with preterm birth: secondary analysis of data from universal health visiting. BMC Pregnancy Childbirth 2022;22:129. doi: 10.1186/s12884-022-04454-z
doi: 10.1186/s12884-022-04454-z
Braveman P, Dominguez TP, Burke W, Dolan SM, Stevenson DK, Jackson FM, et al. Explaining the Black-White disparity in preterm birth: a consensus statement from a multi-disciplinary scientific work group convened by the March of Dimes. Front Reprod Health 2021;3:684207. doi: 10.3389/frph.2021.684207
doi: 10.3389/frph.2021.684207
Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol 2005;106:1071–83. doi: 10.1097/01.AOG.0000183597.31630.db
doi: 10.1097/01.AOG.0000183597.31630.db
Sakowicz A, Allen E, Alvarado-Goldberg M, Grobman WA, Miller ES. Association between antenatal depression symptom trajectories and preterm birth. Obstet Gynecol 2023;141:810–7. doi: 10.1097/AOG.0000000000005125
doi: 10.1097/AOG.0000000000005125
Baer RJ, Chambers CD, Ryckman KK, Oltman SP, Rand L, Jelliffe-Pawlowski LL. Risk of preterm and early term birth by maternal drug use. J Perinatol 2019;39:286–94. doi: 10.1038/s41372-018-0299-0
doi: 10.1038/s41372-018-0299-0
Carey JC, Klebanoff MA, Hauth JC, Hillier SL, Thom EA, Ernest JM, et al. Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis. N Engl J Med 2000;342:534–40. doi: 10.1056/NEJM200002243420802
doi: 10.1056/NEJM200002243420802
Brocklehurst P, Gordon A, Heatley E, Milan SJ. Antibiotics for treating bacterial vaginosis in pregnancy. The Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD000262. doi: 10.1002/14651858.CD000262.pub4
doi: 10.1002/14651858.CD000262.pub4
Sangkomkamhang US, Lumbiganon P, Prasertcharoensuk W, Laopaiboon M. Antenatal lower genital tract infection screening and treatment programs for preventing preterm delivery. The Cochrane Database of Systematic Reviews 2015, Issue 2. Art. No.: CD006178. doi: 10.1002/14651858.CD006178.pub3
doi: 10.1002/14651858.CD006178.pub3
Leitich H, Kiss H. Asymptomatic bacterial vaginosis and intermediate flora as risk factors for adverse pregnancy outcome. Best Pract Res Clin Obstet Gynaecol 2007;21:375–90. doi: 10.1016/j.bpobgyn.2006.12.005
doi: 10.1016/j.bpobgyn.2006.12.005
Fettweis JM, Serrano MG, Brooks JP, Edwards DJ, Girerd PH, Parikh HI, et al. The vaginal microbiome and preterm birth. Nat Med 2019;25:1012–21. doi: 10.1038/s41591-019-0450-2
doi: 10.1038/s41591-019-0450-2
Menzies R, Li ALK, Melamed N, Shah PS, Horn D, Barrett J, et al. Risk of singleton preterm birth after prior twin preterm birth: a systematic review and meta-analysis. Am J Obstet Gynecol 2020;223:204.e1–8. doi: 10.1016/j.ajog.2020.02.003
doi: 10.1016/j.ajog.2020.02.003