The Effects of Aspirin in Gestation and Reproduction

Summary

The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.

Timeline

Start

2007-06

Primary completion

2012-07

Completion

2012-07

Publications

• Lee IT, Barnhart KT, Hwang WT, Hinkle SN, Johnstone E, Mills JL, Caniglia EC, Schisterman EF, Mendola P, Ryan GL, Hotaling J, Peterson CM, Van Voorhis BJ, Mumford SL. Association between markers of female adiposity and live birth among patients undergoing fertility treatment or attempting unassisted conception. Hum Reprod. 2025 Sep 1;40(9):1671-1680. doi: 10.1093/humrep/deaf124.
• Freeman JR, Whitcomb BW, Bertone-Johnson ER, O'Brien LM, Dunietz GL, Purdue-Smithe AC, Kim K, Silver RM, Schisterman EF, Mumford SL. Preconception sleep, pregnancy loss, and adverse pregnancy outcomes among women with a history of pregnancy loss. Hum Reprod. 2025 Jul 1;40(7):1366-1376. doi: 10.1093/humrep/deaf074.
• Freeman JR, Whitcomb BW, Bertone-Johnson ER, O'Brien LM, Dunietz GL, Purdue-Smithe AC, Kim K, Silver RM, Schisterman EF, Mumford SL. Sleep characteristics in association with risk of sporadic anovulation among eumenorrheic women. Chronobiol Int. 2025 Apr;42(4):500-510. doi: 10.1080/07420528.2025.2481165. Epub 2025 Mar 31.
• Nobles CJ, Mendola P, Kim K, Pollack AZ, Mumford SL, Perkins NJ, Silver RM, Schisterman EF. Preconception Phthalate Exposure and Women's Reproductive Health: Pregnancy, Pregnancy Loss, and Underlying Mechanisms. Environ Health Perspect. 2023 Dec;131(12):127013. doi: 10.1289/EHP12287. Epub 2023 Dec 13.
• Nobles CJ, Mendola P, Mumford SL, Silver RM, Kim K, Perkins NJ, Schisterman EF. The Relationship of Preconception and Early Pregnancy Isoprostanes with Fecundability and Pregnancy Loss. Epidemiology. 2023 Sep 1;34(5):759-766. doi: 10.1097/EDE.0000000000001631. Epub 2023 Jul 31.
• Freeman JR, Whitcomb BW, Bertone-Johnson ER, Balzer LB, O'Brien LM, Dunietz GL, Purdue-Smithe AC, Kim K, Silver RM, Schisterman EF, Mumford SL. Preconception sleep duration, sleep timing, and shift work in association with fecundability and live birth among women with a history of pregnancy loss. Fertil Steril. 2023 Feb;119(2):252-263. doi: 10.1016/j.fertnstert.2022.10.026. Epub 2022 Dec 29.
• Schliep KC, Hinkle SN, Kim K, Sjaarda LA, Silver RM, Stanford JB, Purdue-Smithe A, Plowden TC, Schisterman EF, Mumford SL. Prospectively assessed perceived stress associated with early pregnancy losses among women with history of pregnancy loss. Hum Reprod. 2022 Sep 30;37(10):2264-2274. doi: 10.1093/humrep/deac172.
• Zolton JR, Sjaarda LA, Mumford SL, Holland TL, Kim K, Flannagan KS, Yisahak SF, Hinkle SN, Connell MT, White MV, Perkins NJ, Silver RM, Hill MJ, DeCherney AH, Schisterman EF. Preconception hemoglobin A1c concentration in healthy women is not associated with fecundability or pregnancy loss. F S Rep. 2022 Jan 20;3(1):39-46. doi: 10.1016/j.xfre.2022.01.002. eCollection 2022 Mar.
• Zhong Y, Brooks MM, Kennedy EH, Bodnar LM, Naimi AI. Use of Machine Learning to Estimate the Per-Protocol Effect of Low-Dose Aspirin on Pregnancy Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e2143414. doi: 10.1001/jamanetworkopen.2021.43414.
• Purdue-Smithe AC, Kim K, Schliep KC, DeVilbiss EA, Hinkle SN, Ye A, Perkins NJ, Sjaarda LA, Silver RM, Schisterman EF, Mumford SL. Preconception caffeine metabolites, caffeinated beverage intake, and fecundability. Am J Clin Nutr. 2022 Apr 1;115(4):1227-1236. doi: 10.1093/ajcn/nqab435.
• Purdue-Smithe AC, Kim K, Andriessen VC, Pollack AZ, Sjaarda LA, Silver RM, Schisterman EF, Mumford SL. Preconception leukocyte telomere length and pregnancy outcomes among women with demonstrated fecundity. Hum Reprod. 2021 Nov 18;36(12):3122-3130. doi: 10.1093/humrep/deab201.
• Alkhalaf Z, Kim K, Kuhr DL, Radoc JG, Purdue-Smithe A, Pollack AZ, Yisahak SF, Silver RM, Thoma M, Kissell K, Perkins NJ, Sjaarda LA, Mumford SL. Markers of vitamin D metabolism and premenstrual symptoms in healthy women with regular cycles. Hum Reprod. 2021 Jun 18;36(7):1808-1820. doi: 10.1093/humrep/deab089.
• Naimi AI, Perkins NJ, Sjaarda LA, Mumford SL, Platt RW, Silver RM, Schisterman EF. The Effect of Preconception-Initiated Low-Dose Aspirin on Human Chorionic Gonadotropin-Detected Pregnancy, Pregnancy Loss, and Live Birth : Per Protocol Analysis of a Randomized Trial. Ann Intern Med. 2021 May;174(5):595-601. doi: 10.7326/M20-0469. Epub 2021 Jan 26.
• Mumford SL, Flannagan KS, Radoc JG, Sjaarda LA, Zolton JR, Metz TD, Plowden TC, Perkins NJ, DeVilbiss EA, Andriessen VC, A C PS, Kim K, Yisahak SF, Freeman JR, Alkhalaf Z, Silver RM, Schisterman EF. Cannabis use while trying to conceive: a prospective cohort study evaluating associations with fecundability, live birth and pregnancy loss. Hum Reprod. 2021 Apr 20;36(5):1405-1415. doi: 10.1093/humrep/deaa355.
• Flannagan KS, Mumford SL, Sjaarda LA, Radoc JG, Perkins NJ, Andriessen VC, Zolton JR, Silver RM, Schisterman EF. Is opioid use safe in women trying to conceive? Epidemiology. 2020 Nov;31(6):844-851. doi: 10.1097/EDE.0000000000001247.
• Sjaarda LA, Radoc JG, Flannagan KS, Mumford SL, Kim K, Perkins NJ, Silver RM, Schisterman EF. Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: a prospective cohort study of fecundability and pregnancy loss. Fertil Steril. 2020 Dec;114(6):1278-1287. doi: 10.1016/j.fertnstert.2020.06.037. Epub 2020 Oct 14.
• Evans MB, Nobles CJ, Kim K, Hill MJ, DeCherney AH, Silver RM, Mumford SL, Sjaarda LA, Perkins NJ, Schisterman EF. Low-dose aspirin in reproductive health: effects on menstrual cycle characteristics. Fertil Steril. 2020 Dec;114(6):1263-1270. doi: 10.1016/j.fertnstert.2020.06.022. Epub 2020 Sep 4.
• Nobles CJ, Mendola P, Mumford SL, Silver RM, Kim K, Andriessen VC, Connell M, Sjaarda L, Perkins NJ, Schisterman EF. Preconception Blood Pressure and Its Change Into Early Pregnancy: Early Risk Factors for Preeclampsia and Gestational Hypertension. Hypertension. 2020 Sep;76(3):922-929. doi: 10.1161/HYPERTENSIONAHA.120.14875. Epub 2020 Aug 3.
• Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
• Yeung EH, Guan W, Zeng X, Salas LA, Mumford SL, de Prado Bert P, van Meel ER, Malmberg A, Sunyer J, Duijts L, Felix JF, Czamara D, Hamalainen E, Binder EB, Raikkonen K, Lahti J, London SJ, Silver RM, Schisterman EF. Cord blood DNA methylation reflects cord blood C-reactive protein levels but not maternal levels: a longitudinal study and meta-analysis. Clin Epigenetics. 2020 Apr 30;12(1):60. doi: 10.1186/s13148-020-00852-2.
• Russo LM, Whitcomb BW, Freeman JR, Mumford SL, Sjaarda LA, Perkins NJ, Schliep KC, Grewal J, Silver RM, Schisterman EF. Physical activity and incidence of subclinical and clinical pregnancy loss: a secondary analysis in the effects of aspirin in gestation and reproduction randomized trial. Fertil Steril. 2020 Mar;113(3):601-608.e1. doi: 10.1016/j.fertnstert.2019.10.027.
• Robinson SL, Mumford SL, Guan W, Zeng X, Kim K, Radoc JG, Trinh MH, Flannagan K, Schisterman EF, Yeung E. Maternal fatty acid concentrations and newborn DNA methylation. Am J Clin Nutr. 2020 Mar 1;111(3):613-621. doi: 10.1093/ajcn/nqz311.
• Agrawala S, Sjaarda LA, Omosigho UR, Perkins NJ, Silver RM, Mumford SL, Connell MT, Naimi AI, Halvorson LM, Schisterman EF. Effect of preconception low dose aspirin on pregnancy and live birth according to socioeconomic status: A secondary analysis of a randomized clinical trial. PLoS One. 2019 Apr 18;14(4):e0200533. doi: 10.1371/journal.pone.0200533. eCollection 2019.
• Mumford SL, Browne RW, Kim K, Nichols C, Wilcox B, Silver RM, Connell MT, Holland TL, Kuhr DL, Omosigho UR, Perkins NJ, Radin R, Sjaarda LA, Schisterman EF. Preconception Plasma Phospholipid Fatty Acids and Fecundability. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4501-4510. doi: 10.1210/jc.2018-00448.
• Mumford SL, Garbose RA, Kim K, Kissell K, Kuhr DL, Omosigho UR, Perkins NJ, Galai N, Silver RM, Sjaarda LA, Plowden TC, Schisterman EF. Association of preconception serum 25-hydroxyvitamin D concentrations with livebirth and pregnancy loss: a prospective cohort study. Lancet Diabetes Endocrinol. 2018 Sep;6(9):725-732. doi: 10.1016/S2213-8587(18)30153-0. Epub 2018 May 31.
• Gibbins KJ, Mumford SL, Sjaarda LA, Branch DW, Perkins NJ, Ye A, Schisterman EF, Silver RM. Preconception antiphospholipid antibodies and risk of subsequent early pregnancy loss. Lupus. 2018 Aug;27(9):1437-1445. doi: 10.1177/0961203318776089. Epub 2018 May 17.
• Russo LM, Whitcomb BW, Mumford SL, Hawkins M, Radin RG, Schliep KC, Silver RM, Perkins NJ, Kim K, Omosigho UR, Kuhr DL, Holland TL, Sjaarda LA, Schisterman EF. A prospective study of physical activity and fecundability in women with a history of pregnancy loss. Hum Reprod. 2018 Jul 1;33(7):1291-1298. doi: 10.1093/humrep/dey086.
• Nobles CJ, Mendola P, Mumford SL, Naimi AI, Yeung EH, Kim K, Park H, Wilcox B, Silver RM, Perkins NJ, Sjaarda L, Schisterman EF. Preconception Blood Pressure Levels and Reproductive Outcomes in a Prospective Cohort of Women Attempting Pregnancy. Hypertension. 2018 May;71(5):904-910. doi: 10.1161/HYPERTENSIONAHA.117.10705. Epub 2018 Apr 2.
• Kuhr DL, Sjaarda LA, Alkhalaf Z, Omosigho UR, Connell MT, Silver RM, Kim K, Perkins NJ, Holland TL, Plowden TC, Schisterman EF, Mumford SL. Vitamin D is associated with bioavailability of androgens in eumenorrheic women with prior pregnancy loss. Am J Obstet Gynecol. 2018 Jun;218(6):608.e1-608.e6. doi: 10.1016/j.ajog.2018.03.012. Epub 2018 Mar 13.
• Sjaarda LA, Mumford SL, Kuhr DL, Holland TL, Silver RM, Plowden TC, Perkins NJ, Schisterman EF. Association of testosterone and antimullerian hormone with time to pregnancy and pregnancy loss in fecund women attempting pregnancy. Fertil Steril. 2018 Mar;109(3):540-548.e1. doi: 10.1016/j.fertnstert.2017.11.014. Epub 2018 Feb 7.
• Radin RG, Sjaarda LA, Silver RM, Nobles CJ, Mumford SL, Perkins NJ, Wilcox BD, Pollack AZ, Schliep KC, Plowden TC, Schisterman EF. C-Reactive protein in relation to fecundability and anovulation among eumenorrheic women. Fertil Steril. 2018 Feb;109(2):232-239.e1. doi: 10.1016/j.fertnstert.2017.10.025. Epub 2018 Jan 6.
• Plowden TC, Schisterman EF, Sjaarda LA, Perkins NJ, Silver R, Radin R, Kim K, Galai N, DeCherney AH, Mumford SL. Thyroid-stimulating hormone, anti-thyroid antibodies, and pregnancy outcomes. Am J Obstet Gynecol. 2017 Dec;217(6):697.e1-697.e7. doi: 10.1016/j.ajog.2017.09.001. Epub 2017 Sep 14.
• Pugh SJ, Schisterman EF, Browne RW, Lynch AM, Mumford SL, Perkins NJ, Silver R, Sjaarda L, Stanford JB, Wactawski-Wende J, Wilcox B, Grantz KL. Preconception maternal lipoprotein levels in relation to fecundability. Hum Reprod. 2017 May 1;32(5):1055-1063. doi: 10.1093/humrep/dex052.
• Sjaarda LA, Radin RG, Silver RM, Mitchell E, Mumford SL, Wilcox B, Galai N, Perkins NJ, Wactawski-Wende J, Stanford JB, Schisterman EF. Preconception Low-Dose Aspirin Restores Diminished Pregnancy and Live Birth Rates in Women With Low-Grade Inflammation: A Secondary Analysis of a Randomized Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1495-1504. doi: 10.1210/jc.2016-2917.
• Radin RG, Sjaarda LA, Perkins NJ, Silver RM, Chen Z, Lesher LL, Galai N, Wactawski-Wende J, Mumford SL, Schisterman EF. Low-Dose Aspirin and Sporadic Anovulation in the EAGeR Randomized Trial. J Clin Endocrinol Metab. 2017 Jan 1;102(1):86-92. doi: 10.1210/jc.2016-2095.
• Hinkle SN, Mumford SL, Grantz KL, Silver RM, Mitchell EM, Sjaarda LA, Radin RG, Perkins NJ, Galai N, Schisterman EF. Association of Nausea and Vomiting During Pregnancy With Pregnancy Loss: A Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 Nov 1;176(11):1621-1627. doi: 10.1001/jamainternmed.2016.5641.
• Zarek SM, Mitchell EM, Sjaarda LA, Mumford SL, Silver RM, Stanford JB, Galai N, Schliep KC, Radin RG, Plowden TC, DeCherney AH, Schisterman EF. Antimullerian hormone and pregnancy loss from the Effects of Aspirin in Gestation and Reproduction trial. Fertil Steril. 2016 Apr;105(4):946-952.e2. doi: 10.1016/j.fertnstert.2015.12.003. Epub 2015 Dec 17.
• Zarek SM, Mitchell EM, Sjaarda LA, Mumford SL, Silver RM, Stanford JB, Galai N, White MV, Schliep KC, DeCherney AH, Schisterman EF. Is Anti-Mullerian Hormone Associated With Fecundability? Findings From the EAGeR Trial. J Clin Endocrinol Metab. 2015 Nov;100(11):4215-21. doi: 10.1210/jc.2015-2474. Epub 2015 Sep 25.
• Radin RG, Mumford SL, Silver RM, Lesher LL, Galai N, Faraggi D, Wactawski-Wende J, Townsend JM, Lynch AM, Simhan HN, Sjaarda LA, Perkins NJ, Zarek SM, Schliep KC, Schisterman EF. Sex ratio following preconception low-dose aspirin in women with prior pregnancy loss. J Clin Invest. 2015 Sep;125(9):3619-26. doi: 10.1172/JCI82357. Epub 2015 Aug 17.
• Silver RM, Ahrens K, Wong LF, Perkins NJ, Galai N, Lesher LL, Faraggi D, Wactawski-Wende J, Townsend JM, Lynch AM, Mumford SL, Sjaarda L, Schisterman EF. Low-dose aspirin and preterm birth: a randomized controlled trial. Obstet Gynecol. 2015 Apr;125(4):876-884. doi: 10.1097/AOG.0000000000000736.
• Schisterman EF, Mumford SL, Schliep KC, Sjaarda LA, Stanford JB, Lesher LL, Wactawski-Wende J, Lynch AM, Townsend JM, Perkins NJ, Zarek SM, Tsai MY, Chen Z, Faraggi D, Galai N, Silver RM. Preconception low dose aspirin and time to pregnancy: findings from the effects of aspirin in gestation and reproduction randomized trial. J Clin Endocrinol Metab. 2015 May;100(5):1785-91. doi: 10.1210/jc.2014-4179. Epub 2015 Feb 24.
• Schisterman EF, Silver RM, Lesher LL, Faraggi D, Wactawski-Wende J, Townsend JM, Lynch AM, Perkins NJ, Mumford SL, Galai N. Preconception low-dose aspirin and pregnancy outcomes: results from the EAGeR randomised trial. Lancet. 2014 Jul 5;384(9937):29-36. doi: 10.1016/S0140-6736(14)60157-4. Epub 2014 Apr 2.

Drugs

Indications