ArticlesPreconception low-dose aspirin and pregnancy outcomes: results from the EAGeR randomised trial
Introduction
Pregnancy loss is a common adverse event, estimated to occur in up to 30% of conceptions.1 Women who have had a pregnancy loss are at increased risk of having a subsequent loss and other adverse pregnancy events.2 The pathophysiological mechanisms that lead to adverse pregnancy outcomes are not fully understood, although decreased blood flow and increased inflammation can have important roles.3 Since aspirin can improve blood flow and reduce inflammation in reproductive organs,4 it might be useful for the improvement of pregnancy outcomes.
Post-conception use of low-dose aspirin has been studied extensively with respect to recurrent pregnancy loss (usually defined as at least two losses) and is often prescribed to prevent pregnancy loss, despite its unproven efficacy.5, 6, 7, 8, 9, 10, 11, 12, 13, 14 Preconception use of low-dose aspirin improves endometrial growth and vascularisation in women undergoing in-vitro fertilisation (IVF).15 Thus, preconception-initiated low-dose aspirin might positively affect downstream pregnancy outcomes during a crucial treatment window. However, this possibility has not been extensively assessed.
The aim of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial was to assess whether daily preconception-initiated treatment with low-dose aspirin improves the livebirth rate compared with placebo in women with one to two previous pregnancy losses.
Section snippets
Study design and participants
EAGeR was a multicentre, block-randomised, double-blind, placebo-controlled clinical trial in four university medical centres in the USA. Inclusion and exclusion criteria have been detailed elsewhere.16 Briefly, initial inclusion criteria (applied for recruitment of the original stratum) included women aged 18–40 years who were actively trying to conceive and who had a history of only one previous pregnancy loss at less than 20 weeks' gestation during the previous year; up to one previous
Results
1228 women were recruited and randomly assigned in blocks (by centre and eligibility stratum) between June 15, 2007, and July 15, 2011. 1078 participants completed the study and were included in the analysis (figure 1). Treatment groups were similar with respect to the assessed demographic and baseline characteristics (table 1).
Among all trial participants, the treatment groups did not differ significantly with respect to the primary outcome of livebirth rate, although a significant difference
Discussion
Overall, preconception-initiated treatment with low-dose aspirin was not significantly associated with livebirth rates, pregnancy loss, or other pregnancy complications. To our knowledge, this is the first study to show that preconception-initiated low-dose aspirin does not decrease the risk of pregnancy loss in women without a history of recurrent pregnancy loss (ie, only one to two previous losses). Thus, our data do not support the general use of low-dose aspirin to decrease the risk of
References (26)
- et al.
The mechanism of action of aspirin
Thromb Res
(2003) - et al.
Recurrent pregnancy loss with antiphospholipid antibody: a systematic review of therapeutic trials
Obstet Gynecol
(2002) - et al.
Antiphospholipid syndrome in pregnancy: a randomized, controlled trial of treatment
Obstet Gynecol
(2002) - et al.
Low-molecular-weight heparin versus low-dose aspirin in women with one fetal loss and a constitutional thrombophilic disorder
Blood
(2004) - et al.
Low-dose aspirin treatment improves ovarian responsiveness, uterine and ovarian blood flow velocity, implantation, and pregnancy rates in patients undergoing in vitro fertilization: a prospective, randomized, double-blind placebo-controlled assay
Fertil Steril
(1999) - et al.
Low-dose aspirin for in vitro fertilization or intracytoplasmic sperm injection: a systematic review and a meta-analysis of the literature
J Thromb Haemost
(2012) - et al.
Management of antiphospholipid syndrome
J Autoimmun
(2009) - et al.
Time of implantation of the conceptus and loss of pregnancy
N Engl J Med
(1999) - et al.
Risk factors for spontaneous abortion and its recurrence
Am J Epidemiol
(1988) - et al.
Sporadic and recurrent pregnancy loss
Anticoagulants for the treatment of recurrent pregnancy loss in women without antiphospholipid syndrome
Cochrane Database Syst Rev
Aspirin plus heparin or aspirin alone in women with recurrent miscarriage
N Engl J Med
Aspirin or anticoagulants for treating recurrent miscarriage in women without antiphospholipid syndrome
Cochrane Database Syst Rev
Cited by (161)
Preeclampsia: Guidelines for clinical practice from the French College of Obstetricians and Gynecologists
2024, Gynecologie Obstetrique Fertilite et SenologieLow-dose aspirin therapy for the prevention of preeclampsia: time to reconsider our recommendations?
2023, American Journal of Obstetrics and GynecologyEvaluating the effectiveness of interventions: A comprehensive scoring system versus testing for statistical significance
2023, European Journal of Obstetrics and Gynecology and Reproductive BiologyPreconception sleep duration, sleep timing, and shift work in association with fecundability and live birth among women with a history of pregnancy loss
2023, Fertility and SterilityCitation Excerpt :This is a secondary analysis of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, a block-randomized, double-blind, placebo-controlled trial conducted in the United States from 2006 to 2012 including women recruited from Utah, New York, Pennsylvania, and Colorado (37, 38).
Nutritional supplements and other adjuvants in fertility care
2023, Handbook of Current and Novel Protocols for the Treatment of InfertilityAssociation Between Low-Dose Aspirin and Development of Gestational Diabetes: A Systematic Review and Meta-Analysis
2022, Journal of Obstetrics and Gynaecology Canada