ABSTRACT
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.
Subject(s)
Acidosis/diagnosis , Acidosis/epidemiology , Decision Making, Computer-Assisted , Fetal Distress/diagnosis , Fetal Monitoring/methods , Acidosis/blood , Acidosis/prevention & control , Adult , Apgar Score , Cesarean Section/statistics & numerical data , Clinical Alarms , Female , Fetal Distress/surgery , Humans , Hypoxia-Ischemia, Brain/epidemiology , Incidence , Infant, Newborn , Intensive Care Units, Neonatal , Labor, Obstetric , Patient Admission/statistics & numerical data , Perinatal Death , Pregnancy , Signal Processing, Computer-Assisted , Young AdultABSTRACT
Vaginally administered nitric oxide donors such as isosorbide mononitrate have been used to ripen the uterine cervix in pregnancy. The pharmacokinetics of isosorbide mononitrate following vaginal administration are unknown. Serum levels of isosorbide mononitrate were determined at baseline and 60, 180 and 360 minutes after vaginal administration of 20 or 40 mg isosorbide mononitrate to pregnant women scheduled for induction of labour at term. Serum levels of isosorbide mononitrate continued to rise up to 360 minutes after isosorbide mononitrate insertion, with mean (SD) final levels of 337 (94) microg/L following isosorbide mononitrate 40 mg and 144 (47) microg/L following isosorbide mononitrate 20 mg, P < 0.01.
