title: Strategy for standardization of preeclampsia research study design.
abstract: Preeclampsia remains a major problem worldwide for mothers and babies. Despite intensive study, we have not been able to improve the management or early recognition of preeclampsia. At least part of this is because of failure to standardize the approach to studying this complex syndrome. It is possible that within the syndrome there may be different phenotypes with pathogenic pathways that differ between the subtypes. The capacity to recognize and to exploit different subtypes is of obvious importance for prediction, prevention, and treatment. We present a strategy for research to study preeclampsia, which will allow discrimination of such possible subtypes and also allow comparison and perhaps combinations of findings in different studies by standardized data and biosample collection. To make studies relevant to current clinical practice, the definition of preeclampsia can be that currently used and accepted. However, more importantly, sufficient data should be collected to allow other diagnostic criteria to be used and applied retrospectively. To that end, we present what we consider to be the minimum requirements for a data set in a study of preeclampsia that will facilitate comparisons. We also present a comprehensive or optimal data set for in-depth investigation of pathophysiology. As we approach the definition of phenotypes of preeclampsia by clinical and biochemical criteria, adherence to standardized protocols will hasten our understanding of the causes of preeclampsia and development of targeted treatment strategies.
authors.affiliation: Department of Obstetrics and Gynecology, Center for Pregnancy and Newborn Research, University of Texas Health Science Center, San Antonio, Mail Code 7836, 7703 Floyd Curl Dr, San Antonio, TX 78229. Myattl@uthscsa.edu.
authors.forename: Leslie
authors.initials: L
authors.lastname: Myatt
authors.forename: Christopher W
authors.initials: CW
authors.lastname: Redman
authors.forename: Anne Cathrine
authors.initials: AC
authors.lastname: Staff
authors.forename: Stefan
authors.initials: S
authors.lastname: Hansson
authors.forename: Melissa L
authors.initials: ML
authors.lastname: Wilson
authors.forename: Hannele
authors.initials: H
authors.lastname: Laivuori
authors.forename: Lucilla
authors.initials: L
authors.lastname: Poston
authors.forename: James M
authors.initials: JM
authors.lastname: Roberts
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000592:standards*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D005260:Female; D005865:Gestational Age; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D011225:Pre-Eclampsia / Q000145:classification / Q000175:diagnosis* / Q000628:therapy*; D011247:Pregnancy; D012015:Reference Standards; D012107:Research Design / Q000592:standards*; D016216:Ultrasonography, Prenatal
keywords: hypertension; placenta; pre-eclampsia; pregnancy; proteinuria