title: Central Fetal Monitoring With and Without Computer Analysis: A Randomized Controlled Trial.
abstract: To evaluate whether intrapartum fetal monitoring with computer analysis and real-time alerts decreases the rate of newborn metabolic acidosis or obstetric intervention when compared with visual analysis.
  
  
  
  A randomized clinical trial carried out in five hospitals in the United Kingdom evaluated women with singleton, vertex fetuses of 36 weeks of gestation or greater during labor. Continuous central fetal monitoring by computer analysis and online alerts (experimental arm) was compared with visual analysis (control arm). Fetal blood sampling and electrocardiographic ST waveform analysis were available in both arms. The primary outcome was incidence of newborn metabolic acidosis (pH less than 7.05 and base deficit greater than 12 mmol/L). Prespecified secondary outcomes included operative delivery, use of fetal blood sampling, low 5-minute Apgar score, neonatal intensive care unit admission, hypoxic-ischemic encephalopathy, and perinatal death. A sample size of 3,660 per group (N=7,320) was planned to be able to detect a reduction in the rate of metabolic acidosis from 2.8% to 1.8% (two-tailed α of 0.05 with 80% power).
  
  
  
  From August 2011 through July 2014, 32,306 women were assessed for eligibility and 7,730 were randomized: 3,961 to computer analysis and online alerts, and 3,769 to visual analysis. Baseline characteristics were similar in both groups. Metabolic acidosis occurred in 16 participants (0.40%) in the experimental arm and 22 participants (0.58%) in the control arm (relative risk 0.69 [0.36-1.31]). No statistically significant differences were found in the incidence of secondary outcomes.
  
  
  
  Compared with visual analysis, computer analysis of fetal monitoring signals with real-time alerts did not significantly reduce the rate of metabolic acidosis or obstetric intervention. A lower-than-expected rate of newborn metabolic acidosis was observed in both arms of the trial.
  
  
  
  ISRCTN Registry, http://www.isrctn.com, ISRCTN42314164.
authors.affiliation: Medical School, University of Porto, S. João Hospital, and I3S, Instituto de Investigação e Inovação em Saúde-INEB: Institute of Biomedical Engineering, Porto, Portugal; and St. George's University Hospitals NHS Foundation Trust, London, University Hospital of Wales, Cardiff, Glan Clwyd Hospital, Rhyl, Ninewells Hospital, Dundee, and Leighton Hospital, Crewe, United Kingdom.
authors.forename: Inês
authors.initials: I
authors.lastname: Nunes
authors.forename: Diogo
authors.initials: D
authors.lastname: Ayres-de-Campos
authors.forename: Austin
authors.initials: A
authors.lastname: Ugwumadu
authors.forename: Pina
authors.initials: P
authors.lastname: Amin
authors.forename: Philip
authors.initials: P
authors.lastname: Banfield
authors.forename: Antony
authors.initials: A
authors.lastname: Nicoll
authors.forename: Simon
authors.initials: S
authors.lastname: Cunningham
authors.forename: Paulo
authors.initials: P
authors.lastname: Sousa
authors.forename: Cristina
authors.initials: C
authors.lastname: Costa-Santos
authors.forename: João
authors.initials: J
authors.lastname: Bernardes
mesh_terms: D000138:Acidosis / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology* / Q000517:prevention & control; D000328:Adult; D001034:Apgar Score; D002585:Cesarean Section / Q000706:statistics & numerical data; D056902:Clinical Alarms; D003658:Decision Making, Computer-Assisted; D005260:Female; D005316:Fetal Distress / Q000175:diagnosis* / Q000601:surgery; D005323:Fetal Monitoring / Q000379:methods*; D006801:Humans; D020925:Hypoxia-Ischemia, Brain / Q000453:epidemiology; D015994:Incidence; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007743:Labor, Obstetric; D010343:Patient Admission / Q000706:statistics & numerical data; D066087:Perinatal Death; D011247:Pregnancy; D012815:Signal Processing, Computer-Assisted; D055815:Young Adult