Risk Assessment for Predicting Imminent Delivery in Early-Onset Preeclampsia

Longitudinal serum biomarkers at the Onset of Early-Onset Preeclampsia for Predicting Imminent Delivery and maternal-fetal adverse outcomes: A Prospective, Blinded, Multicenter Study - Longitudinal serum biomarkers at the Onset of Early-Onset Preeclampsia for Predicting Imminent Delivery and maternal-fetal adverse outcomes: A Prospective, Blinded, Multicenter Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060106

Enrollment

Registered

2025-12-18

Start date

2024-07-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Predictive accuracy of sFlt-1 and the sFlt-1/PlGF ratio for delivery within 3 and 7 days.	—

Secondary

Measure	Time frame
1. Predictive accuracy of sFlt-1 and the sFlt-1/PlGF ratio for preeclampsia with severe features and severe maternal-fetal adverse outcomes. 2. Predictive accuracy of preeclampsia-related clinical parameters known to be associated with preeclampsia (e.g., blood pressure, proteinuria, liver enzymes) for timing of delivery, preeclampsia with severe features, and severe maternal-fetal outcomes. 3. Predictive accuracy of other serum biomarkers (e.g., VEGF family, sEng) for timing of delivery, preeclampsia with severe features, and severe maternal-fetal outcomes. 4. Predictive accuracy of the combined models integrating sFlt-1, PlGF, preeclampsia-related clinical parameters, and other serum biomarkers for timing of delivery, preeclampsia with severe features, and severe maternal-fetal outcomes. 5. Predictive performance of clinically used cutoff values of sFlt-1/PlGF ratio (e.g., 38 and 85) for short-term prediction of preeclampsia with severe features, severe maternal-fetal outcomes, and timing of delivery.	—

Measure

Time frame

1. Predictive accuracy of sFlt-1 and the sFlt-1/PlGF ratio for preeclampsia with severe features and severe maternal-fetal adverse outcomes. 2. Predictive accuracy of preeclampsia-related clinical parameters known to be associated with preeclampsia (e.g., blood pressure, proteinuria, liver enzymes) for timing of delivery, preeclampsia with severe features, and severe maternal-fetal outcomes. 3. Predictive accuracy of other serum biomarkers (e.g., VEGF family, sEng) for timing of delivery, preeclampsia with severe features, and severe maternal-fetal outcomes. 4. Predictive accuracy of the combined models integrating sFlt-1, PlGF, preeclampsia-related clinical parameters, and other serum biomarkers for timing of delivery, preeclampsia with severe features, and severe maternal-fetal outcomes. 5. Predictive performance of clinically used cutoff values of sFlt-1/PlGF ratio (e.g., 38 and 85) for short-term prediction of preeclampsia with severe features, severe maternal-fetal outcomes, and timing of delivery.

—

Countries

Japan

Contacts

Public ContactYu Ariyoshi

The University of Tokyo Hospital Obstetrics and Gynecology

ariyoshiy-gyn@h.u-tokyo.ac.jp03-5800-8657

Outcome results