Abstract：
UNASSIGNED: Fetal Medicine Foundation (FMF) studies suggest that preterm preeclampsia can be predicted in the first trimester by combining biophysical, biochemical, and ultrasound markers and prevented using aspirin. We aimed to evaluate the FMF preterm preeclampsia screening test in nulliparous women.
UNASSIGNED: We conducted a prospective multicenter cohort study of nulliparous women recruited at 11 to 14 weeks. Maternal characteristics, mean arterial blood pressure, PAPP-A (pregnancy-associated plasma protein A), PlGF (placental growth factor) in maternal blood, and uterine artery pulsatility index were collected at recruitment. The risk of preterm preeclampsia was calculated by a third party blinded to pregnancy outcomes. Receiver operating characteristic curves were used to estimate the detection rate (sensitivity) and the false-positive rate (1-specificity) for preterm (<37 weeks) and for early-onset (<34 weeks) preeclampsia according to the FMF screening test and according to the American College of Obstetricians and Gynecologists criteria.
UNASSIGNED: We recruited 7554 participants including 7325 (97%) who remained eligible after 20 weeks of which 65 (0.9%) developed preterm preeclampsia, and 22 (0.3%) developed early-onset preeclampsia. Using the FMF algorithm (cutoff of ≥1 in 110 for preterm preeclampsia), the detection rate was 63.1% for preterm preeclampsia and 77.3% for early-onset preeclampsia at a false-positive rate of 15.8%. Using the American College of Obstetricians and Gynecologists criteria, the equivalent detection rates would have been 61.5% and 59.1%, respectively, for a false-positive rate of 34.3%.
UNASSIGNED: The first-trimester FMF preeclampsia screening test predicts two-thirds of preterm preeclampsia and three-quarters of early-onset preeclampsia in nulliparous women, with a false-positive rate of ≈16%.
UNASSIGNED: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02189148.
UNASSIGNED: We conducted a prospective multicenter cohort study of nulliparous women recruited at 11 to 14 weeks. Maternal characteristics, mean arterial blood pressure, PAPP-A (pregnancy-associated plasma protein A), PlGF (placental growth factor) in maternal blood, and uterine artery pulsatility index were collected at recruitment. The risk of preterm preeclampsia was calculated by a third party blinded to pregnancy outcomes. Receiver operating characteristic curves were used to estimate the detection rate (sensitivity) and the false-positive rate (1-specificity) for preterm (<37 weeks) and for early-onset (<34 weeks) preeclampsia according to the FMF screening test and according to the American College of Obstetricians and Gynecologists criteria.
UNASSIGNED: We recruited 7554 participants including 7325 (97%) who remained eligible after 20 weeks of which 65 (0.9%) developed preterm preeclampsia, and 22 (0.3%) developed early-onset preeclampsia. Using the FMF algorithm (cutoff of ≥1 in 110 for preterm preeclampsia), the detection rate was 63.1% for preterm preeclampsia and 77.3% for early-onset preeclampsia at a false-positive rate of 15.8%. Using the American College of Obstetricians and Gynecologists criteria, the equivalent detection rates would have been 61.5% and 59.1%, respectively, for a false-positive rate of 34.3%.
UNASSIGNED: The first-trimester FMF preeclampsia screening test predicts two-thirds of preterm preeclampsia and three-quarters of early-onset preeclampsia in nulliparous women, with a false-positive rate of ≈16%.
UNASSIGNED: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02189148.
摘要：
■胎儿医学基金会（FMF）的研究表明，通过结合生物物理，可以在妊娠早期预测先兆子痫。生物化学，和超声标记，并阻止使用阿司匹林。我们旨在评估未分娩妇女的FMF早产先兆子痫筛查试验。
■我们在11到14周时招募了一项前瞻性多中心队列研究。产妇特征,平均动脉血压,PAPP-A(妊娠相关血浆蛋白A),母体血液中的PlGF（胎盘生长因子），招募时收集子宫动脉搏动指数。早产先兆子痫的风险由不知道妊娠结局的第三方计算。根据FMF筛查测试和根据美国妇产科学院标准,使用受试者工作特征曲线来估计早产(<37周)和早发型(<34周)先兆子痫的检出率(灵敏度)和假阳性率(1-特异性)。
我们招募了7554名参与者，其中7325名（97%）在20周后仍符合资格，其中65名（0.9%）出现了先兆子痫，22例(0.3%)出现早发型先兆子痫。使用FMF算法（110例先兆子痫的临界值≥1），早产先兆子痫的检出率为63.1%,早发型先兆子痫的检出率为77.3%,假阳性率为15.8%.使用美国妇产科学院的标准，等效检出率为61.5%和59.1%，分别,假阳性率为34.3%。
■孕早期FMF先兆子痫筛查试验预测，在未产妇女中，有三分之二的早产先兆子痫和四分之三的早发型先兆子痫，假阳性率约为16%。
■URL：https://www。clinicaltrials.gov;唯一标识符:NCT02189148.
■我们在11到14周时招募了一项前瞻性多中心队列研究。产妇特征,平均动脉血压,PAPP-A(妊娠相关血浆蛋白A),母体血液中的PlGF（胎盘生长因子），招募时收集子宫动脉搏动指数。早产先兆子痫的风险由不知道妊娠结局的第三方计算。根据FMF筛查测试和根据美国妇产科学院标准,使用受试者工作特征曲线来估计早产(<37周)和早发型(<34周)先兆子痫的检出率(灵敏度)和假阳性率(1-特异性)。
我们招募了7554名参与者，其中7325名（97%）在20周后仍符合资格，其中65名（0.9%）出现了先兆子痫，22例(0.3%)出现早发型先兆子痫。使用FMF算法（110例先兆子痫的临界值≥1），早产先兆子痫的检出率为63.1%,早发型先兆子痫的检出率为77.3%,假阳性率为15.8%.使用美国妇产科学院的标准，等效检出率为61.5%和59.1%，分别,假阳性率为34.3%。
■孕早期FMF先兆子痫筛查试验预测，在未产妇女中，有三分之二的早产先兆子痫和四分之三的早发型先兆子痫，假阳性率约为16%。
■URL：https://www。clinicaltrials.gov;唯一标识符:NCT02189148.
