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Protocol for a Prospective Noninterventional Study
Importance of Early Detection of Preeclampsia in Pregnant Women
- Preeclampsia affects 2%-8% of pregnancies and can lead to high maternal and fetal mortality rates due to late identification.
- Misfolded proteins in urine samples may serve as a promising biomarker for predicting preeclampsia.
Study Objectives and Methods
- Evaluate the value of urine-based detection of misfolded proteins for predicting preeclampsia in women with suspected cases.
- Enroll at least 300 pregnant women with suspected preeclampsia and collect consecutive urine samples for testing.
- Blinded testing for misfolded proteins and other preeclampsia-related biomarkers at enrollment and follow-up visits.
- Assess clinical status and complications at regular intervals until 42 days postpartum.
Current Status and Expected Results
- Enrollment of eligible women ongoing, with 251 participants enrolled as of March 2024.
- Results analysis to begin after completion of follow-up and data collection.
- Expected outcome: Development of an accurate prediction model for preeclampsia, proactive management of suspected cases, and potential reduction of adverse pregnancy outcomes.
Trial Registration and Identifier
- Registered at Chinese Clinical Trials Registry ChiCTR2300074878.
- International Registered Report Identifier (IRRID): PRR1-10.2196/54026.
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