Tokyo, Dec. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060106) titled 'Risk Assessment for Predicting Imminent Delivery in Early-Onset Preeclampsia' on Dec. 18.

Study Type: Observational

Primary Sponsor: Institute - The University of Tokyo

Condition: Condition - Preeclampsia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - While the sFlt-1/PlGF ratio predicts preeclampsia (PE) onset, evidence linking post-onset levels to pregnancy outcomes remains limited. This study aims to evaluate the longitudinal changes in serum biomarkers, particularly sFlt-1 and PlGF, measured at the onset of early-onset PE, and to assess the predictive value for delivery timing and maternal-fetal adverse outcomes. The derivation analysis has already been completed, demonstrating findings suggestive of the clinical utility of sFlt-1 and the sFlt-1/PlGF ratio. Furthermore, this study aims to establish a validation cohort to assess the validity and reproducibility of the findings obtained in the derivation analysis. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Singleton pregnancy 2. Diagnosis of preeclampsia between 22+0 and 33+6 weeks of gestation, requiring hospitalization 3. Pregnant individuals 18 years or older who provided written informed consent Key exclusion criteria - 1. Patients who are unable to provide written informed consent 2. Patients with superimposed preeclampsia 3. Cases in which no serum samples are collected at any point between admission and delivery Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 07 Month 04 Day Date of IRB - 2024 Year 07 Month 18 Day Anticipated trial start date - 2024 Year 07 Month 18 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068743

Disclaimer: Curated by HT Syndication.