title: Complications and Safety of Preconception Low-Dose Aspirin Among Women With Prior Pregnancy Losses.
abstract: OBJECTIVE
  To evaluate complications and safety of preconception low-dose aspirin in 1,228 U.S. women (2007-2011).
  
  
  METHODS
  Evaluation of the safety of low-dose aspirin in the participants and their fetuses was a planned secondary analysis of the Effects of Aspirin in Gestation and Reproduction trial, a multicenter, block-randomized, double-blind, placebo-controlled trial investigating the effect of low-dose aspirin on the incidence of live birth. Women aged 18-40 years with a history of one to two pregnancy losses trying to conceive were randomized to daily low-dose aspirin (81 mg, n=615) or placebo (n=613) and were followed for up to six menstrual cycles or through gestation if they became pregnant. Emergency care visits and possible aspirin-related symptoms were assessed at each study follow-up using standardized safety interviews. In addition, complications for both the participant and her fetus or neonate were captured prospectively using case report forms, interviews conducted during pregnancy and postpartum, and medical records.
  
  
  RESULTS
  The proportion of women with at least one possible aspirin-related symptom during the trial was similar between treatment arms (456 [74%] low-dose aspirin compared with 447 [73%] placebo, P=.65) as was the proportion with at least one emergency care visit (104 [17%] low-dose aspirin compared with 99 [16%] placebo, P=.76). Maternal complications were evenly distributed by treatment arm with the exception of vaginal bleeding, which was more commonly reported in the low-dose aspirin arm (22% compared with 17%, P=.02). The distribution of fetal and neonatal complications-which included three stillbirths, three neonatal deaths, and 10 neonates with birth defect(s)-was similar between treatment arms.
  
  
  CONCLUSIONS
  Although rare but serious complications resulting from low-dose aspirin cannot be ruled out, preconception low-dose aspirin appears to be well tolerated by women trying to conceive, women who become pregnant, and by their fetuses and neonates.
authors.affiliation: Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland; the Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah; the Department of Epidemiology and Environmental Health, University at Buffalo, Buffalo, New York; the Department of Statistics, University of Haifa, Mt. Carmel, Haifa, Israel; the Department of Family, Community and Rural Health, Commonwealth Medical College, Scranton, Pennsylvania; and the Department of Obstetrics and Gynecology, University of Colorado, Aurora, Colorado.
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Ahrens
authors.forename: Robert M
authors.initials: RM
authors.lastname: Silver
authors.forename: Sunni L
authors.initials: SL
authors.lastname: Mumford
authors.forename: Lindsey A
authors.initials: LA
authors.lastname: Sjaarda
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Perkins
authors.forename: Jean
authors.initials: J
authors.lastname: Wactawski-Wende
authors.forename: Noya
authors.initials: N
authors.lastname: Galai
authors.forename: Janet M
authors.initials: JM
authors.lastname: Townsend
authors.forename: Anne M
authors.initials: AM
authors.lastname: Lynch
authors.forename: Laurie L
authors.initials: LL
authors.lastname: Lesher
authors.forename: David
authors.initials: D
authors.lastname: Faraggi
authors.forename: Shvetha
authors.initials: S
authors.lastname: Zarek
authors.forename: Enrique F
authors.initials: EF
authors.lastname: Schisterman
mesh_terms: D000026:Abortion, Habitual; D000293:Adolescent; D000328:Adult; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D011225:Pre-Eclampsia / Q000517:prevention & control; D016742:Preconception Care; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced*; D011256:Pregnancy Outcome; D014481:United States; D014592:Uterine Hemorrhage / Q000139:chemically induced; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin