title: Quantitative cardiotocography to improve fetal assessment during labor: a preliminary randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the effectiveness of a computerized decision support system, referred to as "quantitative cardiotocography" (qCTG), to reduce adverse birth outcomes compared to conventional CTG with fetal blood sampling.
  
  
  METHODS
  A preliminary parallel randomized control trial in a tertiary maternity hospital (Sofia, Bulgaria) was conducted with a sample size of 360 women per trial arm (N=720). Women in labor were recruited between March 2008 and March 2011. Unadjusted relative risks were derived to assess the effect of qCTG on outcomes of interest. A ROC curve was derived to determine the sensitivity and specificity of qCTG to detect acidemia (Clinical trial registration: Current Controlled Trials, http://www.controlled-trials.com/, ISRCTN46449237).
  
  
  METHODS
  Primary outcomes were hypoxia (cord-artery blood pH<7.20), acidemia (umbilical-artery blood pH<7.05), cesarean delivery, and forceps extraction. Secondary outcomes were Apgar score <7 at five minutes, neonatal seizures, and admission to the neonatal intensive care unit (NICU).
  
  
  RESULTS
  Reduced risks were observed for all outcomes of interest in women monitored using qCTG. There was a significant reduction in hypoxia (RR: 0.53; 0.33, 0.84), acidemia (RR: 0.31; 95% CI: 0.12, 0.84), cesarean delivery (95% CI: 0.45, 0.85), and admission to the NICU (RR: 0.33; 95% CI: 0.14, 0.77) in women monitored using qCTG versus conventional CTG.
  
  
  CONCLUSIONS
  qCTG may reduce risk of adverse birth outcomes; however, the small sample size and long recruitment period in this trial may overstate the benefits of this intervention. Further large-scale randomized control trials with sufficient sample size to detect rare adverse events are required prior to the adoption of qCTG in daily clinical practice.
authors: Second Municipal Hospital for Obstetrics and Gynecology Sheynovo, Sofia, Bulgaria; Orthogyn Medical Center, Sofia, Bulgaria. Electronic address: ignatov@orthogyn.com.
authors: Petar N
authors: PN
authors: Ignatov
authors: National Perinatal Epidemiology Centre, Department of Obstetrics and Gynaecology, University College Cork, Cork, Ireland; Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
authors: Jennifer E
authors: JE
authors: Lutomski
mesh_terms: D000138:Acidosis / Q000175:diagnosis*; D000328:Adult; D015148:Cardiotocography / Q000379:methods*; D020000:Decision Support Systems, Clinical; D005260:Female; D005316:Fetal Distress / Q000175:diagnosis*; D005323:Fetal Monitoring / Q000379:methods*; D006340:Heart Rate, Fetal; D006801:Humans; D007231:Infant, Newborn; D007743:Labor, Obstetric; D011247:Pregnancy; D012680:Sensitivity and Specificity; D055815:Young Adult
keywords: Acidemia; Cardiotocography; Cesarean section; Clinical decision support systems; Fetal hypoxia