Detection of Urinary Misfolded Proteins for Imminent Prediction of Preeclampsia in Pregnant Women With Suspected Cases: Protocol for a Prospective Noninterventional Study

• DOI: 10.2196/54026
• Publication Date: 2024-03-21T04:37:27Z
• Authors: Haiyang Tang; Yijia Tian; Jing Fang; Xiaoying Yuan; Minli Yao; Yujia Wang; Yan Feng; Jia Shu; Yan Ni; Ying Yu; Yuanhe Wang; Ping Liang; Xingmin Li; Xiaoxia Bai
• Keywords: Adult; Protein Folding; Clinical Trials as Topic; Computer applications to medicine. Medical informatics; R; R858-859.7; 03 medical and health sciences; 0302 clinical medicine; Pre-Eclampsia; Pregnancy; Predictive Value of Tests; Protocol; Medicine; Humans; Female; Prospective Studies; Biomarkers

Background Preeclampsia (PE) is one of the most common hypertensive diseases, affecting 2%-8% all pregnancies. The high maternal and fetal mortality rates PE are due to a lack early identification affected pregnant women that would have led closer monitoring care. Recent data suggest misfolded proteins might be promising biomarker for prediction, which can detected in urine samples according their congophilia (aggregated) characteristic. Objective main purpose this trial evaluate value congophilia-based detection imminent prediction presenting with suspected PE. secondary objectives demonstrate presence correlates PE-related or neonatal adverse outcomes, establish an accurate model by combining multiple indicators. Methods At least 300 clinical suspicion will enrolled prospective cohort study. Participants should meet following inclusion criteria addition PE: ≥18 years old, gestational week between 20+0 33+6, single pregnancy. Consecutive collected, blinded, tested other biomarkers at enrollment 4 follow-up visits. Clinical assessments status related complications participants performed regular intervals using strict diagnostic criteria. Investigators remain blinded results. Follow-up until 42 days postpartum. Data from medical records, including collected. performance alone combined variables statistically analyzed. Results Enrollment started July 2023 was still open upon manuscript submission. As March 2024, total 251 eligible been study expected continue August 2024. analysis scheduled start after reach endpoint complete Conclusions Upon completion study, we expect derive model, allow proactive management possibly reduce associated pregnancy outcomes. additional prognostic also confirmed. Trial Registration Chinese Trials Registry ChiCTR2300074878; https://www.chictr.org.cn/showproj.html?proj=202096 International Registered Report Identifier (IRRID) PRR1-10.2196/54026