title: Bioassay research methodology: measuring CRH in pregnancy.
abstract: BACKGROUND
  There are documented associations between elevated maternal corticotropin-releasing hormone (CRH) levels and adverse pregnancy outcomes. However, reports of these findings often lack sufficient detail and rationale regarding the bioassay methodology. This shortcoming can be problematic for researchers who do not possess in-depth laboratory sciences knowledge but who want to include bioassays in their investigations or to evaluate published reports. The quality and reliability of CRH measurement results can be significantly affected by variables encountered during sample collection, processing, storage, and bioassay. Thus, it is important to establish research laboratory protocols that are based on well-informed rationales and to carefully consider and control for relevant variables.
  
  
  METHODS
  A synthesis of laboratory sciences literature regarding variables affecting CRH measurement in pregnancy is presented. Additionally, consultation with experienced researchers provided an in-depth understanding of CRH measurement. From these sources, a laboratory protocol for clinical research was developed.
  
  
  RESULTS
  Multiple variables that are specific to the reliability of CRH measurement in pregnancy have been identified. These include sample collection methods, sample processing, sample integrity, sample storage, and the actual assay selected.
  
  
  CONCLUSIONS
  The reliability of CRH measurements can be significantly improved by identifying and controlling for variables encountered during sample collection, processing, storage, and bioassay. Adequate methodological details are difficult to glean solely from the published literature, thus consultation with well-informed researchers is necessary. A protocol for CRH bioassay in clinical research is proposed.
authors.affiliation: University of Utah College of Nursing, Salt Lake City, UT, USA. Gwen.Latendresse@nurs.utah.edu
authors.forename: Gwen
authors.initials: G
authors.lastname: Latendresse
authors.forename: Roberta Jeanne
authors.initials: RJ
authors.lastname: Ruiz
mesh_terms: D001800:Blood Specimen Collection / Q000191:economics / Q000379:methods* / Q000592:standards; D015400:Clinical Nursing Research; D002985:Clinical Protocols; D003346:Corticotropin-Releasing Hormone / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000191:economics / Q000379:methods* / Q000592:standards; D019317:Evidence-Based Medicine; D005260:Female; D006461:Hemolysis; D006801:Humans; D018579:Patient Selection; D010949:Plasma / Q000737:chemistry; D011247:Pregnancy / Q000097:blood*; D011256:Pregnancy Outcome; D011310:Preservatives, Pharmaceutical; D011863:Radioimmunoassay / Q000191:economics / Q000379:methods*; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity; D013696:Temperature; D013997:Time Factors
chemical_list: D011310:Preservatives, Pharmaceutical; D003346:Corticotropin-Releasing Hormone