Enrique F Schisterman1, Sunni L Mumford, Karen C Schliep, Lindsey A Sjaarda, Joseph B Stanford, Laurie L Lesher, Jean Wactawski-Wende, Anne M Lynch, Janet M Townsend, Neil J Perkins, Shvetha M Zarek, Michael Y Tsai, Zhen Chen, David Faraggi, Noya Galai, Robert M Silver. 1. Epidemiology Branch (E.F.S., S.L.M., K.C.S., L.A.S., N.J.P., S.M.Z.) and Biostatistics and Bioinformatics Branch (Z.C.), Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland 20892; Department of Family and Preventive Medicine (J.B.S.), University of Utah, Salt Lake City, Utah 84112; Department of Obstetrics and Gynecology (L.L.L., R.M.S.), University of Utah and Intermountain Healthcare 84111, Salt Lake City, Utah; Department of Epidemiology and Environmental Health (J.W-W.), University at Buffalo, Buffalo, New York 14260; Department of Obstetrics and Gynecology (A.M.L.), University of Colorado, Denver, Colorado 80045; Department of Family, Community and Rural Health (J.M.T.), Commonwealth Medical College, Scranton, Pennsylvania 18509; Department of Laboratory Medicine and Pathology (M.Y.T.), University of Minnesota Medical School, Minneapolis, Minnesota 55455; and Department of Statistics (D.F., N.G.), University of Haifa, Haifa, Israel 3498838.
Abstract
OBJECTIVE: The objective was to determine the effect of preconception-initiated daily low-dose aspirin (LDA; 81 mg/day) treatment on time to pregnancy in women with a history of pregnancy loss. DESIGN: This was a multicenter, block-randomized, double-blind, placebo-controlled trial. Participants were block-randomized by center and eligibility stratum. SETTING: The study was conducted at four U.S.A. medical centers (2007-2012). PARTICIPANTS: Participants women aged 18-40 years actively attempting pregnancy, stratified by eligibility criteria: the "original" stratum, women with one loss <20 weeks' gestation during the previous year; and the "expanded" stratum, women with one or two previous losses of any gestational age regardless of time since loss. INTERVENTION: Daily LDA was compared with matching placebo for up to six menstrual cycles of attempting pregnancy. MAIN OUTCOME MEASURE: Time to hCG detected pregnancy and clinically confirmed pregnancy, analyzed by intention-to-treat, was measured. RESULTS: Of the 1228 women randomly assigned toLDA (n = 615) or placebo (n = 613), 410 (67%) women receiving LDA achieved pregnancy compared to 382 (63%) receiving placebo, corresponding to a fecundability odds ratio (FOR) of 1.14 (95% CI: 0.97, 1.33). Among women in the original stratum (n = 541), LDA was associated with increased fecundability compared to placebo (FOR: 1.28; 95%CI: 1.02, 1.62). CONCLUSIONS:Preconception-initiated LDA treatment resulted in a nonsignificant increase in fecundability of 14% in women with a history of 1-2 pregnancy losses, and a significant increase of 28% in women with a history of only one pregnancy loss of <20 weeks' gestation in the preceding year. Preconception-initiated LDA may increase fecundability in certain women with a recent early pregnancy loss.
RCT Entities:
OBJECTIVE: The objective was to determine the effect of preconception-initiated daily low-dose aspirin (LDA; 81 mg/day) treatment on time to pregnancy in women with a history of pregnancy loss. DESIGN: This was a multicenter, block-randomized, double-blind, placebo-controlled trial. Participants were block-randomized by center and eligibility stratum. SETTING: The study was conducted at four U.S.A. medical centers (2007-2012). PARTICIPANTS: Participantswomen aged 18-40 years actively attempting pregnancy, stratified by eligibility criteria: the "original" stratum, women with one loss <20 weeks' gestation during the previous year; and the "expanded" stratum, women with one or two previous losses of any gestational age regardless of time since loss. INTERVENTION: Daily LDA was compared with matching placebo for up to six menstrual cycles of attempting pregnancy. MAIN OUTCOME MEASURE: Time to hCG detected pregnancy and clinically confirmed pregnancy, analyzed by intention-to-treat, was measured. RESULTS: Of the 1228 women randomly assigned to LDA (n = 615) or placebo (n = 613), 410 (67%) women receiving LDA achieved pregnancy compared to 382 (63%) receiving placebo, corresponding to a fecundability odds ratio (FOR) of 1.14 (95% CI: 0.97, 1.33). Among women in the original stratum (n = 541), LDA was associated with increased fecundability compared to placebo (FOR: 1.28; 95%CI: 1.02, 1.62). CONCLUSIONS: Preconception-initiated LDA treatment resulted in a nonsignificant increase in fecundability of 14% in women with a history of 1-2 pregnancy losses, and a significant increase of 28% in women with a history of only one pregnancy loss of <20 weeks' gestation in the preceding year. Preconception-initiated LDA may increase fecundability in certain women with a recent early pregnancy loss.
Authors: Enrique F Schisterman; Robert M Silver; Laurie L Lesher; David Faraggi; Jean Wactawski-Wende; Janet M Townsend; Anne M Lynch; Neil J Perkins; Sunni L Mumford; Noya Galai Journal: Lancet Date: 2014-04-02 Impact factor: 79.321
Authors: Rose G Radin; Lindsey A Sjaarda; Robert M Silver; Carrie J Nobles; Sunni L Mumford; Neil J Perkins; Brian D Wilcox; Anna Z Pollack; Karen C Schliep; Torie C Plowden; Enrique F Schisterman Journal: Fertil Steril Date: 2018-01-06 Impact factor: 7.329
Authors: Lindsay D Levine; Tiffany L Holland; Keewan Kim; Lindsey A Sjaarda; Sunni L Mumford; Enrique F Schisterman Journal: Can J Physiol Pharmacol Date: 2018-12-18 Impact factor: 2.273
Authors: Lindsey A Sjaarda; Sunni L Mumford; Daniel L Kuhr; Tiffany L Holland; Robert M Silver; Torie C Plowden; Neil J Perkins; Enrique F Schisterman Journal: Fertil Steril Date: 2018-02-07 Impact factor: 7.329
Authors: Kathryn A McInerney; Elizabeth E Hatch; Amelia K Wesselink; Kenneth J Rothman; Ellen M Mikkelsen; Lauren A Wise Journal: Hum Reprod Date: 2016-11-05 Impact factor: 6.918
Authors: Matthew T Connell; Lindsey A Sjaarda; Rose G Radin; Daniel Kuhr; Sunni L Mumford; Torie C Plowden; Robert M Silver; Enrique F Schisterman Journal: Semin Reprod Med Date: 2017-10-16 Impact factor: 1.303
Authors: Edwina H Yeung; Hyojun Park; Carrie Nobles; Sunni L Mumford; Robert Silver; Enrique F Schisterman Journal: Ann Epidemiol Date: 2019-04-11 Impact factor: 3.797
Authors: Rose G Radin; Lindsey A Sjaarda; Neil J Perkins; Robert M Silver; Zhen Chen; Laurie L Lesher; Noya Galai; Jean Wactawski-Wende; Sunni L Mumford; Enrique F Schisterman Journal: J Clin Endocrinol Metab Date: 2017-01-01 Impact factor: 5.958
Authors: Keewan Kim; Enrique F Schisterman; Robert M Silver; Brian D Wilcox; Anne M Lynch; Neil J Perkins; Richard W Browne; Laurie L Lesher; Joseph B Stanford; Aijun Ye; Jean Wactawski-Wende; Sunni L Mumford Journal: Am J Epidemiol Date: 2018-09-01 Impact factor: 4.897