UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060106 |
|---|---|
| Receipt number | R000068743 |
| Scientific Title | Longitudinal serum biomarkers at the Onset of Early-Onset Preeclampsia for Predicting Imminent Delivery and maternal-fetal adverse outcomes: A Prospective, Blinded, Multicenter Study |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/18 08:32:52 |
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Basic information
Public title
Risk Assessment for Predicting Imminent Delivery in Early-Onset Preeclampsia
Acronym
RAPID-EOP study
Scientific Title
Longitudinal serum biomarkers at the Onset of Early-Onset Preeclampsia for Predicting Imminent Delivery and maternal-fetal adverse outcomes: A Prospective, Blinded, Multicenter Study
Scientific Title:Acronym
Longitudinal serum biomarkers at the Onset of Early-Onset Preeclampsia for Predicting Imminent Delivery and maternal-fetal adverse outcomes: A Prospective, Blinded, Multicenter Study
Region
| Japan |
Condition
Condition
Preeclampsia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Clinical efficacy of biomarker
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive accuracy of sFlt-1 and the sFlt-1/PlGF ratio for delivery within 3 and 7 days.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Iriyama |
Organization
The University of Tokyo Hospital
Division name
Obstetrics and Gynecology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8657
iriyama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Ariyoshi |
Organization
The University of Tokyo Hospital
Division name
Obstetrics and Gynecology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8657
Homepage URL
ariyoshiy-gyn@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
Tel
03-5800-8657
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Start date of derivation cohort enrollment:
July 18, 2024
End date of derivation cohort enrollment:
September 30, 2025
Start date of validation cohort enrollment:
October 1, 2025
The derivation cohort has been completed, and recruitment for the validation cohort has begun; however, measurements of the primary outcomes have not yet started.
The target sample size is 50 participants. However, according to the study protocol established prior to study initiation, enrollment of up to 100 participants may be permitted.
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068743
