Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, China.
Department of Ultrasonic Diagnosis, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Ultrasound Obstet Gynecol. 2021 Oct;58(4):529-539. doi: 10.1002/uog.23645.
To evaluate, in a Chinese population, the performance of a screening strategy for preterm pre-eclampsia (PE) using The Fetal Medicine Foundation (FMF)'s competing-risks model and to explore its clinical applicability in mainland China.
This was a prospective, multicenter, observational cohort study including 10 899 women with singleton pregnancy who sought prenatal care at one of 13 hospitals, located in seven cities in mainland China, between 1 December 2017 and 30 December 2019. Mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and maternal serum levels of placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A) at 11 + 0 to 13 + 6 weeks' gestation were measured and converted into multiples of the median using Chinese reference ranges. Individualized risk for preterm PE was calculated using the FMF algorithm. Prior risk was calculated based on maternal demographic characteristics and obstetric history. We evaluated the efficiency of the screening strategy using various combinations of biomarkers and analyzed its predictive performance for a composite of placenta-associated adverse pregnancy outcomes, including PE, placental abruption, small-for-gestational age (SGA) and preterm birth, at fixed false-positive rates for preterm PE.
We identified 312 pregnancies that developed PE, of which 117 cases were diagnosed as preterm PE (< 37 weeks' gestation). There were 386 pregnancies complicated by severe composite placenta-associated adverse outcome, including preterm PE, 146 cases of severe SGA (birth weight < 3 percentile) neonate, 61 cases with placental abruption and 109 cases of early preterm birth < 34 gestational weeks. The triple-marker model containing biomarkers MAP, UtA-PI and PAPP-A achieved, at fixed false-positive rates of 10%, 15% and 20%, detection rates for preterm PE of 65.0%, 72.7% and 76.1%, respectively, and detection rates for severe composite placenta-associated adverse outcome of 34.7%, 41.7% and 46.4%, respectively. Replacing PAPP-A with PlGF or adding PlGF to the model did not improve the performance. Of women screening positive for preterm PE at a fixed 5% false-positive rate, an estimated 30% developed at least one placenta-associated adverse pregnancy outcome, including PE, placental abruption, SGA (birth weight < 10 percentile) and preterm birth < 37 weeks.
The FMF competing-risks model for preterm PE was found to be effective in screening a mainland Chinese population. Women who screened positive for preterm PE had increased risk for other placenta-associated pregnancy complications. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.
在中国人群中评估使用胎儿医学基金会（FMF）竞争风险模型的早产子痫前期（PE）筛查策略的性能，并探讨其在中国内地的临床适用性。
这是一项前瞻性、多中心、观察性队列研究，纳入了 2017 年 12 月 1 日至 2019 年 12 月 30 日期间在中国大陆 7 个城市的 13 家医院寻求产前检查的 10899 名单胎妊娠女性。在 11+0 至 13+6 周妊娠时测量平均动脉压（MAP）、子宫动脉搏动指数（UtA-PI）和母血清胎盘生长因子（PlGF）和妊娠相关血浆蛋白-A（PAPP-A）水平，并使用中国参考范围转换为中位数的倍数。使用 FMF 算法计算早产 PE 的个体风险。先验风险基于产妇的人口统计学特征和产科史。我们使用各种生物标志物组合评估筛查策略的效率，并分析其对胎盘相关不良妊娠结局复合结局（包括 PE、胎盘早剥、小于胎龄儿（SGA）和早产）的预测性能，在固定的早产 PE 假阳性率下。
我们确定了 312 例发生 PE 的妊娠，其中 117 例诊断为早产 PE（<37 周）。386 例妊娠合并严重复合胎盘相关不良结局，包括早产 PE、146 例严重 SGA（出生体重<第 3 百分位）新生儿、61 例胎盘早剥和 109 例早产<34 孕周。包含生物标志物 MAP、UtA-PI 和 PAPP-A 的三标志物模型在固定的假阳性率为 10%、15%和 20%时，早产 PE 的检出率分别为 65.0%、72.7%和 76.1%，严重复合胎盘相关不良结局的检出率分别为 34.7%、41.7%和 46.4%。用 PlGF 替代 PAPP-A 或在模型中添加 PlGF 并不能提高性能。在固定的 5%假阳性率下筛查出早产 PE 阳性的女性中，估计有 30%发生了至少一种胎盘相关的不良妊娠结局，包括 PE、胎盘早剥、SGA（出生体重<第 10 百分位）和早产<37 周。
FMF 早产 PE 竞争风险模型在筛查中国人群中是有效的。筛查出早产 PE 阳性的女性发生其他胎盘相关妊娠并发症的风险增加。© 2021 年国际妇产科超声学会。
