Completed Research

NCT number: NCT03554681 (click on the NCT number to take you to the clinicaltrials.gov to learn more)

This was a prospective, non-interventional, multicentre study involving 10,935 singleton pregnancies at 11-13+6 weeks of gestation across 11 recruiting centres in 7 regions of Asia between December 2016 and June 2018. The aim was to examine the diagnostic accuracy of the Fetal Medicine Foundation Bayes theorem-based model, the American College of Obstetricians and Gynaecologists, and the National Institute for Health and Care Excellence guidelines. In this study, maternal characteristics, as well as medical, obstetric, and drug histories, were recorded. Mean arterial pressure and uterine artery pulsatility indices were measured according to standardised protocols. Maternal serum placental growth factor concentrations were measured using automated analysers. The measured values of mean arterial pressure, uterine artery pulsatility index, and placental growth factor were converted into multiples of the median. The Fetal Medicine Foundation Bayes theorem-based model was used to calculate patient-specific risk for preeclampsia at <37 weeks of gestation (preterm preeclampsia) and at any gestation (all preeclampsia) for each participant. The performance of screening for preterm preeclampsia and all preeclampsia using a combination of maternal factors, mean arterial pressure, uterine artery pulsatility index, and placental growth factor (triple test) was evaluated, with adjustments made for aspirin use. We examined the predictive performance of the model using receiver operating characteristic curves and calibration measurements, including calibration slope and calibration in the large. The detection rate of screening using the Fetal Medicine Foundation Bayes theorem-based model was compared with models derived from the recommendations of the American College of Obstetricians and Gynaecologists and the National Institute for Health and Care Excellence. We found that 224 women (2.05%) experienced preeclampsia, which included 73 cases (0.67%) of preterm preeclampsia. In pregnancies with preterm preeclampsia, the mean multiples of the median values for mean arterial pressure and uterine artery pulsatility index were significantly higher (mean arterial pressure, 1.099 vs 1.008 [P<0.001]; uterine artery pulsatility index, 1.188 vs 1.063 [P=0.006]), while the mean placental growth factor multiples of the median were significantly lower (0.760 vs 1.100 [P<0.001]) compared to women without preeclampsia. The Fetal Medicine Foundation triple test achieved detection rates of 48.2%, 64.0%, 71.8%, and 75.8% at fixed false-positive rates of 5%, 10%, 15%, and 20%, respectively, for predicting preterm preeclampsia. These rates were comparable with previously published data from the Fetal Medicine Foundation study. Screening using the American College of Obstetricians and Gynaecologists recommendations achieved a detection rate of 54.6% at a 20.4% false-positive rate, while the detection rate using National Institute for Health and Care Excellence guidelines was 26.3% at a 5.5% false-positive rate. In conclusion, based on a large cohort of women, this study demonstrates that the Fetal Medicine Foundation Bayes theorem-based model is effective in predicting preterm preeclampsia in an Asian population and that this screening method is superior to the approaches recommended by the American College of Obstetricians and Gynaecologists and the National Institute for Health and Care Excellence. We have also shown that the Fetal Medicine Foundation prediction model can be integrated into routine prenatal care using the existing infrastructure of standard prenatal services.