title: An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and growth restriction (TEST): Trial protocol.
abstract: Pre-eclampsia remains a worldwide cause of maternal and perinatal morbidity and mortality. Low dose aspirin (LDA) can reduce the occurrence of pre-eclampsia in women with identifiable risk factors. Emerging screening tests can determine the maternal risk of developing placental disease, such as pre-eclampsia from the first trimester of pregnancy. The aim of this study is to determine if it is more beneficial in terms of efficacy and acceptability to routinely prescribe LDA to nulliparous low-risk women compared to test indicated LDA on the basis of a positive screening test for placental disease.
  
  
  
  We propose a three armed multi-center open-labeled randomized control trial of; (i) routine LDA, (ii) no aspirin, and (iii) LDA on the basis of a positive first trimester pre-eclampsia screening test. LDA (75mg once daily) shall be given from the first trimester until 36-week gestation. The primary outcome measures include; (i) the proportion of eligible women that agree to participate (acceptability), (ii) compliance with study protocol (acceptability and feasibility), (iii) the proportion of women in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination (feasibility) and (iv) the proportion of women with a completed screening test that are issued the screening result within one week of having the test performed (feasibility).
  
  
  
  This will be the first clinical trial to determine the efficacy and acceptability in low-risk women of taking routine LDA versus no aspirin versus LDA based on a positive first trimester screening test for the prevention of placental disease.
authors.affiliation: UCD Obstetrics and Gynaecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Holles St, Dublin, Ireland; Department of Fetal Medicine, National Maternity Hospital, Holles St, Dublin, Ireland.
authors.forename: Fionnuala
authors.initials: F
authors.lastname: Mone
authors.affiliation: Department of Fetal Medicine, National Maternity Hospital, Holles St, Dublin, Ireland.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Mulcahy
authors.affiliation: Department of Fetal Medicine, National Maternity Hospital, Holles St, Dublin, Ireland.
authors.forename: Peter
authors.initials: P
authors.lastname: McParland
authors.affiliation: Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland, St. Stephen's Green, Dublin, Ireland.
authors.forename: Alice
authors.initials: A
authors.lastname: Stanton
authors.affiliation: Department of Pathology and Laboratory Science, National Maternity Hospital, Holles St, Dublin, Ireland.
authors.forename: Marie
authors.initials: M
authors.lastname: Culliton
authors.affiliation: Department of Pathology and Laboratory Science, National Maternity Hospital, Holles St, Dublin, Ireland.
authors.forename: Paul
authors.initials: P
authors.lastname: Downey
authors.affiliation: Department of Pharmacy, National Maternity Hospital, Holles St, Dublin, Ireland.
authors.forename: Dorothy
authors.initials: D
authors.lastname: McCormack
authors.affiliation: Royal College of Surgeons in Ireland, Rotunda Hospital, Parnell Square, Dublin, Ireland.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Tully
authors.affiliation: Royal College of Surgeons in Ireland, Rotunda Hospital, Parnell Square, Dublin, Ireland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Dicker
authors.affiliation: Royal College of Surgeons in Ireland, Rotunda Hospital, Parnell Square, Dublin, Ireland.
authors.forename: Fionnuala
authors.initials: F
authors.lastname: Breathnach
authors.affiliation: Royal College of Surgeons in Ireland, Rotunda Hospital, Parnell Square, Dublin, Ireland.
authors.forename: Fergal D
authors.initials: FD
authors.lastname: Malone
authors.affiliation: UCD Obstetrics and Gynaecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Holles St, Dublin, Ireland; Department of Fetal Medicine, National Maternity Hospital, Holles St, Dublin, Ireland. Electronic address: Fionnuala.mcauliffe@ucd.ie.
authors.forename: Fionnuala M
authors.initials: FM
authors.lastname: McAuliffe
mesh_terms: D001241:Aspirin / Q000008:administration & dosage*; D042241:Early Diagnosis; D005260:Female; D005317:Fetal Growth Retardation / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D008403:Mass Screening; D055118:Medication Adherence; D010342:Patient Acceptance of Health Care; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011225:Pre-Eclampsia / Q000175:diagnosis / Q000517:prevention & control*; D011247:Pregnancy; D018570:Risk Assessment; D018608:Ultrasonography, Doppler; D055988:Uterine Artery / Q000000981:diagnostic imaging
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin
keywords: Aspirin; First trimester; Low-risk; Placental disease; Pre-eclampsia; Screening