title: Study protocol: PoPE-Prediction of Preterm delivery by Electrohysterography.
abstract: BACKGROUND
  Traditional methods used for prediction of preterm delivery are subjective and inaccurate. The Electrohysterogram (EHG) and in particular the estimation of the EHG conduction velocity, is a relatively new promising method for detecting imminent preterm delivery. To date the analysis of the conduction velocity has relied on visual inspection of the signals. As a next step towards the introduction of EHG analysis as a clinical tool, we propose an automated method for EHG conduction velocity estimation for both the speed and direction of single spike propagation.
  
  
  METHODS
  The study design will be an observational cohort study. 100 pregnant women, gestational age between 23 + 5 and 34 weeks, admitted for threatening preterm labor or preterm prelabor rupture of membranes, will be included. The length of the cervical canal will be measured by transvaginal ultrasound. The EHG will be recorded using 4 electrodes in a fixed configuration. Contractions will be detected by analysis of the EHG and using an estimation of the intra uterine pressure. In the selected contractions, the delays between channels will be estimated by cross-correlation, and subsequently, the average EHG conduction velocity will be derived. Patients will be classified as labor group and non-labor group based on the time between measurement and delivery. The average conduction velocity and cervical length will be compared between the groups. The main study endpoints will be sensitivity, specificity, and area under the ROC curve for delivery within 1,2,4,7, and 14 days from the measurement.
  
  
  CONCLUSIONS
  In this study, the diagnostic accuracy of EHG conduction velocity analysis will be evaluated for detecting preterm labor. Visual and automatic detection of contractions will be compared. Planar wave propagation will be assumed for the calculation of the CV vector.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN07603227.
authors.affiliation: Department of Electrical Engineering, University of Technology Eindhoven, Den Dolech 2, 5612 AZ Eindhoven, the Netherlands. H.deLau@gmail.com.
authors.forename: Hinke
authors.initials: H
authors.lastname: de Lau
authors.forename: Chiara
authors.initials: C
authors.lastname: Rabotti
authors.forename: Herman P
authors.initials: HP
authors.lastname: Oosterbaan
authors.forename: Massimo
authors.initials: M
authors.lastname: Mischi
authors.forename: Guid S
authors.initials: GS
authors.lastname: Oei
mesh_terms: D019540:Area Under Curve; D015331:Cohort Studies; D004576:Electromyography / Q000379:methods; D005260:Female; D005865:Gestational Age; D006801:Humans; D009119:Muscle Contraction / Q000502:physiology; D009215:Myometrium / Q000503:physiopathology*; D011237:Predictive Value of Tests; D011247:Pregnancy; D047928:Premature Birth / Q000175:diagnosis* / Q000503:physiopathology*; D012372:ROC Curve; D012107:Research Design; D012815:Signal Processing, Computer-Assisted; D014599:Uterus / Q000503:physiopathology*