TY - JOUR
T1 - Central fetal monitoring with and without computer analysis
T2 - 2nd European Congress on Intrapartum Care
AU - Nunes, Inês
AU - Ayres-de-Campos, Diogo
AU - Ugwumadu, Austin
AU - Amin, Pina
AU - Banfield, Philip
AU - Nicoll, Antony
AU - Cunningham, Simon
AU - Sousa, Paulo
AU - Costa-Santos, Cristina
AU - Bernardes, João
AU - for the Fetal Monitoring and Alert (FM-ALERT) Study Group
PY - 2017/1
Y1 - 2017/1
N2 - OBJECTIVE: 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.METHODS: 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).RESULTS: 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.CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: ISRCTN Registry, http://www.isrctn.com, ISRCTN42314164.
AB - OBJECTIVE: 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.METHODS: 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).RESULTS: 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.CONCLUSION: 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.CLINICAL TRIAL REGISTRATION: ISRCTN Registry, http://www.isrctn.com, ISRCTN42314164.
UR - http://journals.lww.com/greenjournal/Citation/2017/01000/Central_Fetal_Monitoring_With_and_Without_Computer.11.aspx
U2 - 10.1097/AOG.0000000000001799
DO - 10.1097/AOG.0000000000001799
M3 - Article
C2 - 27926647
SN - 0029-7844
VL - 129
SP - 83
EP - 90
JO - Obstetrics & Gynecology
JF - Obstetrics & Gynecology
IS - 1
Y2 - 21 May 2015 through 23 May 2015
ER -