TY - JOUR
T1 - T rial of feasibility and acceptability of routine low-dose aspirin versus e arly S creening T est indicated aspirin for pre-eclampsia prevention (TEST study)
T2 - A multicentre randomised controlled trial
AU - Mone, Fionnuala
AU - Mulcahy, Cecilia
AU - McParland, Peter
AU - Breathnach, Fionnuala
AU - Downey, Paul
AU - McCormack, Dorothy
AU - Culliton, Marie
AU - Stanton, Alice
AU - Cody, Fiona
AU - Morrison, John J.
AU - Daly, Sean
AU - Higgins, John
AU - Cotter, Amanda
AU - Hunter, Alyson
AU - Tully, Elizabeth C.
AU - DIcker, Patrick
AU - Alfirevic, Zarko
AU - Malone, Fergal D.
AU - McAuliffe, Fionnuala M.
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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. Trial registration number ISRCTN (15191778); Post-results.
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 >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.
KW - aspirin
KW - feasibility
KW - low risk
KW - preeclampsia
KW - screening
UR - http://www.scopus.com/inward/record.url?scp=85053031556&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2018-022056
DO - 10.1136/bmjopen-2018-022056
M3 - Article
C2 - 30056389
AN - SCOPUS:85053031556
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e022056
ER -
