Trial of feasibility and acceptability of routine low-dose aspirin versus early screening test indicated aspirin for pre-eclampsia prevention (TEST study): a multicentre randomised controlled trial

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dc.contributor.authorMone, Fionnuala
dc.contributor.authorMulcahy, Cecilia
dc.contributor.authorMcParland, Peter
dc.contributor.authorBreathnach, Fionnuala M.
dc.contributor.authorDowney, Paul
dc.contributor.authorMcCormack, Dorothy
dc.contributor.authorCulliton, Marie
dc.contributor.authorStanton, Alice
dc.contributor.authorCody, Fiona
dc.contributor.authorMorrison, John J.
dc.contributor.authorDaly, Sean
dc.contributor.authorHiggins, John R.
dc.contributor.authorCotter, Amanda
dc.contributor.authorHunter, Alyson
dc.contributor.authorTully, Elizabeth C.
dc.contributor.authorDicker, Patrick
dc.contributor.authorAlfirevic, Zarko
dc.contributor.authorMalone, Fergal D.
dc.contributor.authorMcAuliffe, Fionnuala M.
dc.contributor.funderHealth Research Board
dc.date.accessioned2018-09-27T12:08:21Z
dc.date.available2018-09-27T12:08:21Z
dc.date.issued2018
dc.description.abstractObjective: Evaluate the feasibility and acceptability of routine aspirin in low-risk women, compared with screening-test indicated aspirin for the prevention of pre-eclampsia and fetal growth restriction. Design: Multicentre open-label feasibility randomised controlled trial. Setting: Two tertiary maternity hospitals in Dublin, Ireland. Participants: 546 low-risk nulliparous women completed the study. Interventions: Women underwent computerised randomisation to: Group 1—routine aspirin 75 mg from 11 until 36 weeks; Group 2—no aspirin and; Group 3—aspirin based on the Fetal Medicine Foundation screening test. Primary and secondary outcome measures: (1) Proportion agreeing to participate; (2) compliance with protocol; (3) proportion where first trimester uterine artery Doppler was obtainable and; (4) time taken to issue a screening result. Secondary outcomes included rates of pre-eclampsia and small-for-gestational-age fetuses. Results: 546 were included in the routine aspirin (n=179), no aspirin (n=183) and screen and treat (n=184) groups. 546 of 1054 were approached (51.8%) and enrolled. Average aspirin adherence was 90%. The uterine artery Doppler was obtained in 98.4% (181/184) and the average time to obtain a screening result was 7.6 (0–26) days. Of those taking aspirin, vaginal spotting was greater; n=29 (15.1%), non-aspirin n=28 (7.9%), OR 2.1 (95% CI 1.2 to 3.6). Postpartum haemorrhage >500 mL was also greater; aspirin n=26 (13.5%), no aspirin n=20 (5.6%), OR 2.6 (95% CI 1.4 to 4.8). Conclusion: Low-risk nulliparous women are open to taking aspirin in pregnancy and had high levels of adherence. Aspirin use was associated with greater rates of vaginal bleeding. An appropriately powered randomised controlled trial is now required to address the efficacy and safety of universal low-dose aspirin in low-risk pregnancy compared with a screening approach.en
dc.description.sponsorshipHealth Research Board (Perinatal Ireland; Mother and Baby Clinical Trials Network)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleide022056
dc.identifier.citationMone, F., Mulcahy, C., McParland, P., Breathnach, F., Downey, P., McCormack, D., Culliton, M., Stanton, A., Cody, F., Morrison, J. J., Daly, S., Higgins, J., Cotter, A., Hunter, A., Tully, E. C., Dicker, P., Alfirevic, Z., Malone, F. D. and McAuliffe, F. M. (2018) 'Trial of feasibility and acceptability of routine low-dose aspirin versus Early Screening Test indicated aspirin for pre-eclampsia prevention (TEST study): a multicentre randomised controlled trial', BMJ Open, 8(7), e022056 (9pp). doi: 10.1136/bmjopen-2018-022056en
dc.identifier.doi10.1136/bmjopen-2018-022056
dc.identifier.endpage9
dc.identifier.issn2044-6055
dc.identifier.issued7
dc.identifier.journaltitleBMJ Openen
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/6940
dc.identifier.volume8
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.relation.urihttps://bmjopen.bmj.com/content/8/7/e022056
dc.rights© 2018, the Author(s) (or their employer(s). This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectPre-eclampsia preventionen
dc.subjectAspirinen
dc.subjectPregnancyen
dc.subjectMaternityen
dc.titleTrial of feasibility and acceptability of routine low-dose aspirin versus early screening test indicated aspirin for pre-eclampsia prevention (TEST study): a multicentre randomised controlled trialen
dc.typeArticle (peer-reviewed)en
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