title: Study protocol for the randomised controlled trial: combined multimarker screening and randomised patient treatment with ASpirin for evidence-based PREeclampsia prevention (ASPRE).
abstract: Pre-eclampsia (PE) affects 2-3% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Prophylactic use of low-dose aspirin in women at risk for PE may substantially reduce the prevalence of the disease. Effective screening for PE requiring delivery before 37 weeks (preterm PE) can be provided by a combination of maternal factors, uterine artery Doppler, mean arterial pressure, maternal serum pregnancy-associated plasma protein A and placental growth factor at 11-13 weeks' gestation, with a detection rate of 75% at a false-positive rate of 10%. We present a protocol (V.6, date 25 January 2016) for the ASpirin for evidence-based PREeclampsia prevention (ASPRE) trial, which is a double-blinded, placebo-controlled, randomised controlled trial (RCT) that uses an effective PE screening programme to determine whether low-dose aspirin given to women from 11 to 13 weeks' gestation will reduce the incidence of preterm PE.
  
  
  
  All eligible women attending for their first trimester scan will be invited to participate in the screening study for preterm PE. Those found to be at high risk of developing preterm PE will be invited to participate in the RCT. Further scans will be conducted for assessment of fetal growth and biomarkers. Pregnancy and neonatal outcomes will be collected and analysed. The first enrolment for the pilot study was in April 2014. As of April 2016, 26 670 women have been screened and 1760 recruited to the RCT. The study is registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry.
  
  
  
  ISRCTN13633058.
authors.affiliation: Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: O'Gorman
authors.affiliation: Institute of Health Research, University of Exeter, Exeter, UK.
authors.forename: David
authors.initials: D
authors.lastname: Wright
authors.affiliation: Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, UK.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Rolnik
authors.affiliation: Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, UK.
authors.forename: Kypros H
authors.initials: KH
authors.lastname: Nicolaides
authors.affiliation: Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, UK.
authors.forename: Liona C
authors.initials: LC
authors.lastname: Poon
mesh_terms: D000293:Adolescent; D000328:Adult; D001241:Aspirin / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D016015:Logistic Models; D008403:Mass Screening / Q000379:methods*; D010865:Pilot Projects; D000072483:Placenta Growth Factor / Q000097:blood; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D011225:Pre-Eclampsia / Q000175:diagnosis / Q000517:prevention & control*; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011266:Pregnancy-Associated Plasma Protein-A / Q000032:analysis; D012107:Research Design; D006113:United Kingdom; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D000072483:Placenta Growth Factor; D011266:Pregnancy-Associated Plasma Protein-A; D001241:Aspirin