title: Study protocol. A prospective cohort study of unselected primiparous women: the pregnancy outcome prediction study.
abstract: BACKGROUND
  There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years. However, the approach to screening for other complications of pregnancy such as intra-uterine growth restriction, pre-eclampsia and stillbirth remains largely unchanged. Randomised controlled trials of routine application of high tech screening methods to the general population have generally failed to show improvement in outcome. We have previously reviewed this and concluded it was due, in large part, to poor performance of screening tests. Here, we report a study design where the primary aim is to generate clinically useful methods to screen women to assess their risk of adverse pregnancy outcome.
  
  
  METHODS
  We report the design of a prospective cohort study of unselected primiparous women recruited at the time of their first ultrasound scan. Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10-14 weeks), 20 weeks, 28 weeks and 36 weeks gestation. In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth. Data will be analysed as a prospective cohort study, a case-cohort study, and a nested case-control study.
  
  
  CONCLUSIONS
  The study is expected to provide a resource for the identification of novel biomarkers for adverse pregnancy outcome and to evaluate the performance of biomarkers and serial ultrasonography in providing clinically useful prediction of risk.
authors.affiliation: Department of Obstetrics and Gynaecology, University of Cambridge, Cambridge, UK. dp349@cam.ac.uk
authors.forename: Dharmintra
authors.initials: D
authors.lastname: Pasupathy
authors.forename: Alison
authors.initials: A
authors.lastname: Dacey
authors.forename: Emma
authors.initials: E
authors.lastname: Cook
authors.forename: D Stephen
authors.initials: DS
authors.lastname: Charnock-Jones
authors.forename: Ian R
authors.initials: IR
authors.lastname: White
authors.forename: Gordon C S
authors.initials: GC
authors.lastname: Smith
mesh_terms: D015415:Biomarkers / Q000097:blood; D004247:DNA / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D010298:Parity / Q000502:physiology*; D011237:Predictive Value of Tests; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis* / Q000453:epidemiology; D011256:Pregnancy Outcome; D011264:Pregnancy Trimesters; D011295:Prenatal Care / Q000379:methods*; D015995:Prevalence; D011446:Prospective Studies; D016216:Ultrasonography, Prenatal / Q000379:methods*; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D015415:Biomarkers; D004247:DNA