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

A previous large randomized trial indicated that preconception-initiated low-dose aspirin (LDA) therapy did not have a positive effect on pregnancy outcomes. However, this trial was subject to nonadherence, which was not taken into account by the intention-to-treat approach. To estimate per protocol...

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Bibliographic Details
Published in:Annals of internal medicine Vol. 174; no. 5; p. 595
Main Authors: Naimi, Ashley I, Perkins, Neil J, Sjaarda, Lindsey A, Mumford, Sunni L, Platt, Robert W, Silver, Robert M, Schisterman, Enrique F
Format: Journal Article
Language:English
Published: United States 01.05.2021
Subjects:
Abortion, Spontaneous
Adult
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Aspirin - administration & dosage
Chorionic Gonadotropin - blood
Female
Humans
Live Birth
Medication Adherence
Preconception Care - methods
Pregnancy
Pregnancy Outcome
United States
United States
ISSN:1539-3704, 1539-3704
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Summary:A previous large randomized trial indicated that preconception-initiated low-dose aspirin (LDA) therapy did not have a positive effect on pregnancy outcomes. However, this trial was subject to nonadherence, which was not taken into account by the intention-to-treat approach. To estimate per protocol effects of preconception-initiated LDA on pregnancy loss and live birth. The EAGeR (Effects of Aspirin on Gestation and Reproduction) trial was used to construct a prospective cohort for a post hoc analysis. (ClinicalTrials.gov: NCT00467363). 4 university medical centers in the United States. 1227 women between the ages of 18 and 40 years who had 1 or 2 previous pregnancy losses and were attempting pregnancy. Adherence to LDA or placebo, assessed by measuring pill bottle weights at regular intervals during follow-up. Primary outcomes were human chorionic gonadotropin (hCG)-detected pregnancies, pregnancy losses, and live births, determined by pregnancy tests and medical records. Relative to placebo, adhering to LDA for 5 of 7 days per week led to 8 more hCG-detected pregnancies (95% CI, 4.64 to 10.96 pregnancies), 15 more live births (CI, 7.65 to 21.15 births), and 6 fewer pregnancy losses (CI, -12.00 to -0.20 losses) for every 100 women in the trial. In addition, compared with placebo, postconception initiation of LDA therapy led to a reduction in the estimated effects. Furthermore, effects were obtained in a minimum of 4 of 7 days per week. The EAGeR trial data for this study were analyzed as observational data, thus are subject to the limitations of prospective observational studies. Per protocol results suggest that preconception use of LDA at least 4 days per week may improve reproductive outcomes for women who have had 1 or 2 pregnancy losses. Increasing adherence to daily LDA seems to be key to improving effectiveness. National Institutes of Health.
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ISSN:1539-3704
1539-3704
DOI:10.7326/M20-0469