title: A critical appraisal of the evidence for using cardiotocography plus ECG ST interval analysis for fetal surveillance in labor. Part I: the randomized controlled trials.
abstract: We reappraised the five randomized controlled trials that compared cardiotocography plus ECG ST interval analysis (CTG+ST) vs. cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in operative delivery for fetal distress. There were considerable differences in study design: the French randomized controlled trial used different inclusion criteria, and the Finnish randomized controlled trial (n = 1483) used a different metabolic acidosis definition. In the CTG+ST study arms, the larger Plymouth, Swedish and Dutch trials showed lower operative delivery and metabolic acidosis rates, whereas the smaller Finnish and French trials showed minor differences in operative delivery and higher metabolic acidosis rates. We conclude that the differences in outcomes are likely due to the considerable differences in study design and size. This will enhance heterogeneity effects in any subsequent meta-analysis.
authors.affiliation: Department of Obstetrics and Gynecology, Institution of Clinical Sciences, Skåne University Hospital, Lund University, Malmö, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Olofsson
authors.forename: Diogo
authors.initials: D
authors.lastname: Ayres-de-Campos
authors.forename: Jörg
authors.initials: J
authors.lastname: Kessler
authors.forename: Britta
authors.initials: B
authors.lastname: Tendal
authors.forename: Branka M
authors.initials: BM
authors.lastname: Yli
authors.forename: Lawrence
authors.initials: L
authors.lastname: Devoe
mesh_terms: D000138:Acidosis / Q000175:diagnosis* / Q000503:physiopathology / Q000601:surgery; D015148:Cardiotocography; D004562:Electrocardiography / Q000379:methods*; D005316:Fetal Distress / Q000175:diagnosis* / Q000503:physiopathology / Q000601:surgery; D006340:Heart Rate, Fetal / Q000502:physiology; D006801:Humans; D016032:Randomized Controlled Trials as Topic
keywords: Cardiotocography; ST analysis; fetal surveillance; meta-analysis; metabolic acidosis; randomized controlled trial