Evidence map›Paper›PMID 33493011›Full record

Trial reportAnnals of internal medicine2021

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.

Ashley I Naimi, Neil J Perkins, Lindsey A Sjaarda, Sunni L Mumford, Robert W Platt, Robert M Silver, Enrique F Schisterman

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of internal medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00467363 (The Effects of Aspirin in Gestation and Reproduction), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00467363 nacompletednot on this map

The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2007 to 2012Enrolled1,228ConditionsBirth, Spontaneous AbortionArmsacetylsalicylic-acid (aspirin), Folic acid
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
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  11. Role of the vaginal microbiome in miscarriage: exploring the relationship.Frontiers in cellular and infection microbiology · 2023
    Review
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  13. Article
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  16. The Role of the Natural Course in Causal Analysis.American journal of epidemiology · 2022
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Ashley I NaimiEmory University, Atlanta, Georgia (A.I.N.).
Neil J PerkinsEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland (N.J.P., L.A.S., S.L.M., E.F.S.).
Lindsey A SjaardaEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland (N.J.P., L.A.S., S.L.M., E.F.S.).
Sunni L MumfordEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland (N.J.P., L.A.S., S.L.M., E.F.S.).ORCID 0000-0003-0133-3176
Robert W PlattMcGill University, Montreal, Quebec, Canada (R.W.P.).ORCID 0000-0002-5981-8443
Robert M Silverand University of Utah, Salt Lake City, Utah (R.M.S.).
Enrique F SchistermanEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland (N.J.P., L.A.S., S.L.M., E.F.S.).ORCID 0000-0003-3757-641X
Eunice Kennedy Shriver National Institute of Child Health and Human Development · USEmory University · USMcGill University · CAUniversity of Utah · US

Funding

EAGeR Trial - The Effects of Aspirin in Gestation and Reproduction TrialZIAHD008795 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI PERKINS, NEIL · 2009 to 2025
$9.6M
Informing national guidelines on diet patterns that promote healthy pregnancy outcomesR01HD102313 · NICHD · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BODNAR, LISA M, NAIMI, ASHLEY ISAAC · 2020 to 2024
$3.0M
ROC Curve MethodologyZIAHD008761 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI SCHISTERMAN, ENRIQUE F. · 2009 to 2021
$2.1M
Estimating the Effect of Low-Dose Aspirin on Fetal Loss in a Trial with Non-ComplianceR01HD093602 · NICHD · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI NAIMI, ASHLEY ISAAC · 2018 to 2021
$1.2M
NICHD NIH HHS R01 HD093602NICHD NIH HHS R01 HD102313
6 · The paper itself

Abstract

backgroundA 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.

objectiveTo estimate per protocol effects of preconception-initiated LDA on pregnancy loss and live birth.

designThe EAGeR (Effects of Aspirin on Gestation and Reproduction) trial was used to construct a prospective cohort for a post hoc analysis. (ClinicalTrials.gov: NCT00467363).

setting4 university medical centers in the United States.

participants1227 women between the ages of 18 and 40 years who had 1 or 2 previous pregnancy losses and were attempting pregnancy. MEASUREMENTS: 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.

resultsRelative 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. LIMITATION: The EAGeR trial data for this study were analyzed as observational data, thus are subject to the limitations of prospective observational studies.

conclusionPer 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. PRIMARY FUNDING SOURCE: National Institutes of Health.

Indexed as

Pregnancy OutcomeAbortion, SpontaneousAdultAnti-Inflammatory Agents, Non-SteroidalAspirinChorionic GonadotropinFemaleHumansLive BirthMedication AdherencePreconception CarePregnancyUnited StatesAnti-Inflammatory Agents, Non-SteroidalAspirinChorionic Gonadotropin

Identifiers

PMID33493011
PMCPMC9109822
OpenAlexW3126030694

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.