title: Preconception low dose aspirin and time to pregnancy: findings from the effects of aspirin in gestation and reproduction randomized trial.
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.
  
  
  METHODS
  This was a multicenter, block-randomized, double-blind, placebo-controlled trial. Participants were block-randomized by center and eligibility stratum.
  
  
  METHODS
  The study was conducted at four U.S.A. medical centers (2007-2012).
  
  
  METHODS
  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.
  
  
  METHODS
  Daily LDA was compared with matching placebo for up to six menstrual cycles of attempting pregnancy.
  
  
  METHODS
  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.affiliation: 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.
authors.forename: Enrique F
authors.initials: EF
authors.lastname: Schisterman
authors.forename: Sunni L
authors.initials: SL
authors.lastname: Mumford
authors.forename: Karen C
authors.initials: KC
authors.lastname: Schliep
authors.forename: Lindsey A
authors.initials: LA
authors.lastname: Sjaarda
authors.forename: Joseph B
authors.initials: JB
authors.lastname: Stanford
authors.forename: Laurie L
authors.initials: LL
authors.lastname: Lesher
authors.forename: Jean
authors.initials: J
authors.lastname: Wactawski-Wende
authors.forename: Anne M
authors.initials: AM
authors.lastname: Lynch
authors.forename: Janet M
authors.initials: JM
authors.lastname: Townsend
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Perkins
authors.forename: Shvetha M
authors.initials: SM
authors.lastname: Zarek
authors.forename: Michael Y
authors.initials: MY
authors.lastname: Tsai
authors.forename: Zhen
authors.initials: Z
authors.lastname: Chen
authors.forename: David
authors.initials: D
authors.lastname: Faraggi
authors.forename: Noya
authors.initials: N
authors.lastname: Galai
authors.forename: Robert M
authors.initials: RM
authors.lastname: Silver
mesh_terms: D000293:Adolescent; D000328:Adult; D001241:Aspirin / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D011247:Pregnancy; D011256:Pregnancy Outcome; D061685:Time-to-Pregnancy; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin