RT Journal Article
SR Electronic
T1 <em>T</em>rial of feasibility and acceptability of routine low-dose aspirin versus <em>E</em>arly <em>S</em>creening <em>T</em>est indicated aspirin for pre-eclampsia prevention (<em>TEST</em> study): a multicentre randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e022056
DO 10.1136/bmjopen-2018-022056
VO 8
IS 7
A1 Fionnuala Mone
A1 Cecilia Mulcahy
A1 Peter McParland
A1 Fionnuala Breathnach
A1 Paul Downey
A1 Dorothy McCormack
A1 Marie Culliton
A1 Alice Stanton
A1 Fiona Cody
A1 John J Morrison
A1 Sean Daly
A1 John Higgins
A1 Amanda Cotter
A1 Alyson Hunter
A1 Elizabeth C Tully
A1 Patrick Dicker
A1 Zarko Alfirevic
A1 Fergal D Malone
A1 Fionnuala M McAuliffe
YR 2018
UL http://bmjopen.bmj.com/content/8/7/e022056.abstract
AB 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 &gt;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.Trial registration number ISRCTN (15191778); Post-results.