JMIR Publications

ABSTRACT

Background:

Pre-eclampsia (PE) is the most common hypertensive diseases, affecting 2% - 8% of all pregnancies. High maternal and fetal mortality of PE is due to a lack of early identification of affected pregnant women for more close care. Recent data suggested that the misfolded protein might be a promising biomarker for PE prediction.

Objective:

The main purpose of this trial is to evaluate the value of a urine Congophilia based detection of misfolded proteins for imminent prediction of PE in women presenting with suspected PE.

Methods:

In this prospective cohort, at least 300 pregnant women with clinical suspicion of PE will be enrolled. Consecutive urine samples will be collected, blinded and tested for misfolded proteins and other PE-related biomarkers at enrollment and 4 weeks thereafter. Clinical assessments of PE status and related complications for all subjects will be performed at regular intervals using strict diagnostic criteria. Investigators and participants will remain blinded to the results. Follow-up will be conducted until 42 days postpartum. Medical records include maternal and fetal outcomes will be collected. The performance of urine misfolded proteins alone or combined with other biomarkers or clinical variables for prediction of PE will be analyzed.

Results:

Enrollment started in July 2023 and was still open at the date of submission. Results analysis is scheduled to start after all subjects reached the follow-up endpoint and full clinical data 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 adverse pregnancy outcomes Clinical Trial: Chinese Clinical Trial Registry; ChiCTR2300074878 (https://www.chictr.org.cn/).