Inter- and intra-observer variability in fetal ductus venosus blood flow measurements in high-risk fetuses at 26-32 weeks.

OBJECTIVES: Early preterm fetal growth restriction is a significant contributor to perinatal morbidity and mortality. The ductus venosus pulsatility index for veins (DV PIV) is proposed as a monitoring tool because it appears to improve perinatal outcomes. The test characteristics and robustness of DV PIV have been inadequately described. The aim of this study was to investigate inter- and intra-observer variability of DV PIV. STUDY DESIGN: Nineteen women with a gestational age between 26 and 32 completed weeks were included in this study. Doppler sonographic fetal assessment was performed by two independent maternal-fetal medicine specialists. Each sonographer alternately performed three flow tracings for each participant, in the absence of the other sonographer (six tracings in total per patient). DV PIV was calculated automatically from stored tracings by a third researcher. Inter- and intra-observer variability of DV PIV and limits of agreement were assessed using the Bland-Altman method. Comparison of the distribution was performed with Kendall's related samples test, and the intraclass correlation coefficient (ICC) was calculated. RESULTS: In total, 114 DV measurements were taken from 19 participants with a median age of 31 years [interquartile range (IQR) 26-34 years] at a median gestational age of 28 weeks (IQR 27-29 weeks). The proportional limits of agreement for intra-observer variation were -0.48 to 0.48 and -0.39 to 0.62 for the two observers. ICCs were 0.66 [95% confidence interval (CI) 0.42-0.84] and 0.68 (95% CI 0.45-0.85). The proportional limits of agreement for inter-observer variation were -0.29 to 0.19 with an ICC of 0.89 (95% CI 0.73-0.96). CONCLUSION: Inter-observer variation was far less than intra-observer variation, probably due to mitigation of biological variation by averaging three measurements. DV PIV has acceptable test characteristics for use in a clinical setting when the average of at least three consecutive measurements is used.

Phase-rectified signal averaging method to predict perinatal outcome in infants with very preterm fetal growth restriction- a secondary analysis of TRUFFLE-trial.

BACKGROUND: Phase-rectified signal averaging, an innovative signal processing technique, can be used to investigate quasi-periodic oscillations in noisy, nonstationary signals that are obtained from fetal heart rate. Phase-rectified signal averaging is currently the best method to predict survival after myocardial infarction in adult cardiology. Application of this method to fetal medicine has established significantly better identification than with short-term variation by computerized cardiotocography of growth-restricted fetuses. OBJECTIVE: The aim of this study was to determine the longitudinal progression of phase-rectified signal averaging indices in severely growth-restricted human fetuses and the prognostic accuracy of the technique in relation to perinatal and neurologic outcome. STUDY DESIGN: Raw data from cardiotocography monitoring of 279 human fetuses were obtained from 8 centers that took part in the multicenter European "TRUFFLE" trial on optimal timing of delivery in fetal growth restriction. Average acceleration and deceleration capacities were calculated by phase-rectified signal averaging to establish progression from 5 days to 1 day before delivery and were compared with short-term variation progression. The receiver operating characteristic curves of average acceleration and deceleration capacities and short-term variation were calculated and compared between techniques for short- and intermediate-term outcome. RESULTS: Average acceleration and deceleration capacities and short-term variation showed a progressive decrease in their diagnostic indices of fetal health from the first examination 5 days before delivery to 1 day before delivery. However, this decrease was significant 3 days before delivery for average acceleration and deceleration capacities, but 2 days before delivery for short-term variation. Compared with analysis of changes in short-term variation, analysis of (delta) average acceleration and deceleration capacities better predicted values of Apgar scores <7 and antenatal death (area under the curve for prediction of antenatal death: delta average acceleration capacity, 0.62 [confidence interval, 0.19-1.0]; delta short-term variation, 0.54 [confidence interval, 0.13-0.97]; P=.006; area under the curve for prediction Apgar <7: average deceleration capacity <24 hours before delivery, 0.64 [confidence interval, 0.52-0.76]; short-term variation <24 hours before delivery, 0.53 [confidence interval, 0.40-0.65]; P=.015). Neither phase-rectified signal averaging indices nor short-term variation showed predictive power for developmental disability at 2 years of age (Bayley developmental quotient, <95 or <85). CONCLUSION: The phase-rectified signal averaging method seems to be at least as good as short-term variation to monitor progressive deterioration of severely growth-restricted fetuses. Our findings suggest that for short-term outcomes such as Apgar score, phase-rectified signal averaging indices could be an even better test than short-term variation. Overall, our findings confirm the possible value of prospective trials based on phase-rectified signal averaging indices of autonomic nervous system of severely growth-restricted fetuses.