PDF(Pubmed)
Abstract：
BACKGROUND: Preeclampsia (PE) is one of the most common hypertensive diseases, affecting 2%-8% of all pregnancies. The high maternal and fetal mortality rates of PE are due to a lack of early identification of affected pregnant women that would have led to closer monitoring and care. Recent data suggest that misfolded proteins might be a promising biomarker for PE prediction, which can be detected in urine samples of pregnant women according to their congophilia (aggregated) characteristic.
OBJECTIVE: The main purpose of this trial is to evaluate the value of the urine congophilia-based detection of misfolded proteins for the imminent prediction of PE in women presenting with suspected PE. The secondary objectives are to demonstrate that the presence of urine misfolded proteins correlates with PE-related maternal or neonatal adverse outcomes, and to establish an accurate PE prediction model by combining misfolded proteins with multiple indicators.
METHODS: At least 300 pregnant women with clinical suspicion of PE will be enrolled in this prospective cohort study. Participants should meet the following inclusion criteria in addition to a suspicion of PE: ≥18 years old, gestational week between 20+0 and 33+6, and single pregnancy. Consecutive urine samples will be collected, blinded, and tested for misfolded proteins and other PE-related biomarkers at enrollment and at 4 follow-up visits. Clinical assessments of PE status and related complications for all participants will be performed at regular intervals using strict diagnostic criteria. Investigators and participants will remain blinded to the results. Follow-up will be performed until 42 days postpartum. Data from medical records, including maternal and fetal outcomes, will be collected. The performance of urine misfolded proteins alone and combined with other biomarkers or clinical variables for the prediction of PE will be statistically analyzed.
RESULTS: Enrollment started in July 2023 and was still open upon manuscript submission. As of March 2024, a total of 251 eligible women have been enrolled in the study and enrollment is expected to continue until August 2024. Results analysis is scheduled to start after all participants reach the follow-up endpoint and complete clinical data are collected.
CONCLUSIONS: Upon completion of the study, we expect to derive an accurate PE prediction model, which will allow for proactive management of pregnant women with clinical suspicion of PE and possibly reduce the associated adverse pregnancy outcomes. The additional prognostic value of misfolded proteins is also expected to be confirmed.
BACKGROUND: Chinese Clinical Trials Registry ChiCTR2300074878; https://www.chictr.org.cn/showproj.html?proj=202096.
UNASSIGNED: PRR1-10.2196/54026.
OBJECTIVE: The main purpose of this trial is to evaluate the value of the urine congophilia-based detection of misfolded proteins for the imminent prediction of PE in women presenting with suspected PE. The secondary objectives are to demonstrate that the presence of urine misfolded proteins correlates with PE-related maternal or neonatal adverse outcomes, and to establish an accurate PE prediction model by combining misfolded proteins with multiple indicators.
METHODS: At least 300 pregnant women with clinical suspicion of PE will be enrolled in this prospective cohort study. Participants should meet the following inclusion criteria in addition to a suspicion of PE: ≥18 years old, gestational week between 20+0 and 33+6, and single pregnancy. Consecutive urine samples will be collected, blinded, and tested for misfolded proteins and other PE-related biomarkers at enrollment and at 4 follow-up visits. Clinical assessments of PE status and related complications for all participants will be performed at regular intervals using strict diagnostic criteria. Investigators and participants will remain blinded to the results. Follow-up will be performed until 42 days postpartum. Data from medical records, including maternal and fetal outcomes, will be collected. The performance of urine misfolded proteins alone and combined with other biomarkers or clinical variables for the prediction of PE will be statistically analyzed.
RESULTS: Enrollment started in July 2023 and was still open upon manuscript submission. As of March 2024, a total of 251 eligible women have been enrolled in the study and enrollment is expected to continue until August 2024. Results analysis is scheduled to start after all participants reach the follow-up endpoint and complete clinical data are collected.
CONCLUSIONS: Upon completion of the study, we expect to derive an accurate PE prediction model, which will allow for proactive management of pregnant women with clinical suspicion of PE and possibly reduce the associated adverse pregnancy outcomes. The additional prognostic value of misfolded proteins is also expected to be confirmed.
BACKGROUND: Chinese Clinical Trials Registry ChiCTR2300074878; https://www.chictr.org.cn/showproj.html?proj=202096.
UNASSIGNED: PRR1-10.2196/54026.
摘要：
背景：子痫前期（PE）是最常见的高血压疾病之一，影响所有怀孕的2%-8%。PE的高孕产妇和胎儿死亡率是由于缺乏早期识别受影响的孕妇，这将导致更密切的监测和护理。最近的数据表明，错误折叠的蛋白质可能是PE预测的有希望的生物标志物，根据孕妇的血友病（聚集）特征，可以在孕妇的尿液样本中检测到。
目的：本试验的主要目的是评估基于尿血友病的错误折叠蛋白检测对疑似PE女性即将发生PE的预测价值。次要目标是证明尿液错误折叠蛋白的存在与PE相关的母体或新生儿不良结局相关。并将错折叠蛋白与多指标相结合,建立准确的PE预测模型。
方法：这项前瞻性队列研究将招募至少300名临床怀疑PE的孕妇。除怀疑PE外，参与者应符合以下纳入标准：≥18岁，孕周在20+0和33+6之间，单胎妊娠。将连续收集尿液样本，失明,并在入组时和4次随访时检测错误折叠蛋白和其他PE相关生物标志物。所有参与者的PE状态和相关并发症的临床评估将使用严格的诊断标准定期进行。研究人员和参与者将对结果视而不见。随访至产后42天。来自医疗记录的数据，包括母婴结局,将被收集。将对单独的尿液错误折叠蛋白以及与其他生物标志物或临床变量组合用于预测PE的性能进行统计分析。
结果：报名于2023年7月开始，在提交手稿时仍然开放。截至2024年3月，共有251名符合条件的女性参加了这项研究，预计招生将持续到2024年8月。结果分析计划在所有参与者达到随访终点后开始，并收集完整的临床数据。
结论：研究完成后，我们希望得到一个准确的PE预测模型，这将允许对临床怀疑PE的孕妇进行积极管理，并可能减少相关的不良妊娠结局。错误折叠蛋白的额外预后价值也有望得到证实。
背景：中国临床试验注册ChiCTR2300074878;https://www.chictr.org.cn/showproj.html?proj=202096。
■PRR1-10.2196/54026。
目的：本试验的主要目的是评估基于尿血友病的错误折叠蛋白检测对疑似PE女性即将发生PE的预测价值。次要目标是证明尿液错误折叠蛋白的存在与PE相关的母体或新生儿不良结局相关。并将错折叠蛋白与多指标相结合,建立准确的PE预测模型。
方法：这项前瞻性队列研究将招募至少300名临床怀疑PE的孕妇。除怀疑PE外，参与者应符合以下纳入标准：≥18岁，孕周在20+0和33+6之间，单胎妊娠。将连续收集尿液样本，失明,并在入组时和4次随访时检测错误折叠蛋白和其他PE相关生物标志物。所有参与者的PE状态和相关并发症的临床评估将使用严格的诊断标准定期进行。研究人员和参与者将对结果视而不见。随访至产后42天。来自医疗记录的数据，包括母婴结局,将被收集。将对单独的尿液错误折叠蛋白以及与其他生物标志物或临床变量组合用于预测PE的性能进行统计分析。
结果：报名于2023年7月开始，在提交手稿时仍然开放。截至2024年3月，共有251名符合条件的女性参加了这项研究，预计招生将持续到2024年8月。结果分析计划在所有参与者达到随访终点后开始，并收集完整的临床数据。
结论：研究完成后，我们希望得到一个准确的PE预测模型，这将允许对临床怀疑PE的孕妇进行积极管理，并可能减少相关的不良妊娠结局。错误折叠蛋白的额外预后价值也有望得到证实。
背景：中国临床试验注册ChiCTR2300074878;https://www.chictr.org.cn/showproj.html?proj=202096。
■PRR1-10.2196/54026。
