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.author Mone, Fionnuala
dc.contributor.author Mulcahy, Cecilia
dc.contributor.author McParland, Peter
dc.contributor.author Breathnach, Fionnuala M.
dc.contributor.author Downey, Paul
dc.contributor.author McCormack, Dorothy
dc.contributor.author Culliton, Marie
dc.contributor.author Stanton, Alice
dc.contributor.author Cody, Fiona
dc.contributor.author Morrison, John J.
dc.contributor.author Daly, Sean
dc.contributor.author Higgins, John R.
dc.contributor.author Cotter, Amanda
dc.contributor.author Hunter, Alyson
dc.contributor.author Tully, Elizabeth C.
dc.contributor.author Dicker, Patrick
dc.contributor.author Alfirevic, Zarko
dc.contributor.author Malone, Fergal D.
dc.contributor.author McAuliffe, Fionnuala M.
dc.date.accessioned 2018-09-27T12:08:21Z
dc.date.available 2018-09-27T12:08:21Z
dc.date.issued 2018
dc.identifier.citation Mone, 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-2018-022056 en
dc.identifier.volume 8
dc.identifier.issued 7
dc.identifier.startpage 1
dc.identifier.endpage 9
dc.identifier.issn 2044-6055
dc.identifier.uri http://hdl.handle.net/10468/6940
dc.identifier.doi 10.1136/bmjopen-2018-022056
dc.description.abstract Objective: 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.sponsorship Health Research Board (Perinatal Ireland; Mother and Baby Clinical Trials Network) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BMJ Publishing Group en
dc.relation.uri https://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.uri http://creativecommons.org/licenses/by-nc/4.0/
dc.subject Pre-eclampsia prevention en
dc.subject Aspirin en
dc.subject Pregnancy en
dc.subject Maternity en
dc.title 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 en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother John R Higgins, Obstetrics & Gynaecology, University College Cork, Cork, Ireland. +353-21-490-3000 Email: j.higgins@ucc.ie en
dc.internal.availability Full text available en
dc.description.version Published Version en
dc.contributor.funder Health Research Board
dc.description.status Peer reviewed en
dc.identifier.journaltitle BMJ Open en
dc.internal.IRISemailaddress j.higgins@ucc.ie en
dc.identifier.articleid e022056


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© 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/. Except where otherwise noted, this item's license is described as © 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/.
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