Evidence map›Paper›PMID 26959198›Full record

Trial reportObstetrics and gynecology2016

Complications and Safety of Preconception Low-Dose Aspirin Among Women With Prior Pregnancy Losses.

Katherine A Ahrens, Robert M Silver, Sunni L Mumford, Lindsey A Sjaarda, Neil J Perkins, Jean Wactawski-Wende, Noya Galai, Janet M Townsend, Anne M Lynch, Laurie L Lesher and 3 more

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
4.0field-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.

NCT04908982 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension: A Pilot Study

TypeinterventionalSponsorEastern Virginia Medical SchoolRan2021 to 2023Enrolled60ConditionsPre-EclampsiaArmsAspirin 81mg
NCT05253781 phase3completednot on this mapstarted 2020, after this paper: background citation

Low Dose Aspirin for Preventing Intrauterine Growth Restriction and Preeclampsia in Sickle Cell Pregnancy (PIPSICKLE): a Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Lagos, NigeriaRan2020 to 2024Enrolled476ConditionsIntrauterine Growth Restriction, Preeclampsia, Sickle Cell Disease, Pregnancy ComplicationsArmsLow-dose aspirin, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.

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  2. Antiplatelet agents for preventing pre-eclampsia and its complications.The Cochrane database of systematic reviews · 2019
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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

13 authors at 1 institution in 1 country.

Katherine A AhrensEpidemiology 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.
Robert M Silver
Sunni L Mumford
Lindsey A Sjaarda
Neil J Perkins
Jean Wactawski-Wende
Noya Galai
Janet M Townsend
Anne M Lynch
Laurie L Lesher
David Faraggi
Shvetha Zarek
Enrique F Schisterman
Eunice Kennedy Shriver National Institute of Child Health and Human Development · 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

objectiveTo evaluate complications and safety of preconception low-dose aspirin in 1,228 U.S. women (2007-2011).

methodsEvaluation 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.

resultsThe 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.

conclusionAlthough 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.

Indexed as

Abortion, HabitualPreconception CareAdolescentAdultAspirinDouble-Blind MethodFemaleHumansInfant, NewbornPlatelet Aggregation InhibitorsPre-EclampsiaPregnancyPregnancy ComplicationsPregnancy OutcomeUnited StatesUterine HemorrhageAspirinPlatelet Aggregation Inhibitors

Identifiers

PMID26959198
PMCPMC4805457
OpenAlexW2298094321

What OpenQuestion 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 OpenQuestion graph.