Evidence map›Paper›PMID 24118062›Full record

Trial reportPaediatric and perinatal epidemiology2013

A randomised trial to evaluate the effects of low-dose aspirin in gestation and reproduction: design and baseline characteristics.

Enrique F Schisterman, Robert M Silver, Neil J Perkins, Sunni L Mumford, Brian W Whitcomb, Joseph B Stanford, Laurie L Lesher, David Faraggi, Jean Wactawski-Wende, Richard W Browne and 4 more

Erratum issuedOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Paediatric and perinatal epidemiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 97 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

97 citing papers in PubMed, 3 syntheses or guidelines pooled it, 109 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Antiplatelet agents for preventing pre-eclampsia and its complications.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Maternal fatty acid concentrations and newborn DNA methylation.The American journal of clinical nutrition · 2020
    Trial
  19. Trial
  20. Trial

37 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

14 authors at 7 institutions in 2 countries.

Enrique F SchistermanEpidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD.
Robert M Silver
Neil J Perkins
Sunni L Mumford
Brian W Whitcomb
Joseph B Stanford
Laurie L Lesher
David Faraggi
Jean Wactawski-Wende
Richard W Browne
Janet M Townsend
Mark White
Anne M Lynch
Noya Galai
Eunice Kennedy Shriver National Institute of Child Health and Human Development · USUniversity of Utah · USCommonwealth Medical College · USUniversity at Buffalo, State University of New York · USUniversity of Haifa · ILUniversity of Colorado Denver · USUniversity of Massachusetts Amherst · 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
EAGeR Trial - The Effects of Aspirin in Gestation and Reproduction TrialZ01HD008795 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI SCHISTERMAN, ENRIQUE · 2007 to 2008
$596k
Intramural NIH HHS Z01 HD008795PHS HHS HHSN267200603423PHS HHS HHSN267200603424PHS HHS HHSN267200603426
6 · The paper itself

Abstract

backgroundLow-dose aspirin (LDA) has been proposed to improve pregnancy outcomes in couples experiencing recurrent pregnancy loss. However, results from studies of LDA on pregnancy outcomes have been inconsistent, perhaps because most studies evaluated LDA-initiated post-conception. The purpose of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial was to determine whether preconception-initiated LDA improves livebirth rates in women with one to two prior losses.

methodsWe performed a multicentre, block randomised, double-blind, placebo-controlled trial. Study participants were recruited using community-based advertisements and physician referral to four university medical centres in the US (2006-12). Eligible women were aged 18-40 years actively trying to conceive, with one to two prior losses. Participants were randomised to receive daily LDA (81 mg/day) or a matching placebo, and all were provided with daily 400-mcg folic acid. Follow-up continued for ≤6 menstrual cycles while attempting to conceive. For those who conceived, treatment was continued until 36 weeks gestation. The primary outcome was the cumulative livebirth rate over the trial period.

resultsThere were 1228 women randomised (615 LDA, 613 placebo). Participants had a mean age of 28.7, were mostly white (95%), well educated (86% more than high school education), and employed (75%) with a household income >$100 000 annually (40%). The characteristics of those in the treatment and placebo arms were well balanced.

conclusionsWe describe the study design, recruitment, data collection, and baseline characteristics of participants enrolled in EAGeR, which aimed to determine the effect of LDA on livebirth and other pregnancy outcomes in these women.

Indexed as

AdolescentAdultAnti-Inflammatory Agents, Non-SteroidalAspirinDouble-Blind MethodFemaleHumansLive BirthPregnancyPregnancy OutcomeReproductionUnited StatesYoung AdultAnti-Inflammatory Agents, Non-SteroidalAspirinconceptionlow-dose aspirinmiscarriagepregnancysubfertility

Identifiers

PMID24118062
PMCPMC3821875
OpenAlexW2104355586

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.