UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053653 |
|---|---|
| Receipt number | R000055813 |
| Scientific Title | prediction and severity of preeclampsia by L-FABP |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2024/02/20 00:46:48 |
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Basic information
Public title
Exploratory study on prediction and severity of preeclampsia by L-FABP
Acronym
prediction and severity of preeclampsia by L-FABP
Scientific Title
prediction and severity of preeclampsia by L-FABP
Scientific Title:Acronym
prediction and severity of preeclampsia by L-FABP
Region
| Japan |
Condition
Condition
hypertensive disorders of pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of serum and urinary L-type fatty acid-binding protein as the predictive factor of preeclampsia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the difference in serum and urinary L-FABP between HDP group and control group.
Key secondary outcomes
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
After 20 weeks of pregnancy
Patients with preeclampsia or risk of developing preeclampsia (cases with any of the following items).
*Systolic blood pressure 130 mmHg or more and/or diastolic blood pressure 80mmHg or more
*Pregnancy proteinuria (g/Cr > 0.3)
*Fetal growth restriction without obvious structural abnormalities
*High uterine artery pulsatility index + notch
Key exclusion criteria
Fetal malformations
chromosomal abnormalities
Consent has not been obtained
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Katsura |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
5202192
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
TEL
0775482267
katsuo14@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Katsura |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
5202192
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
TEL
0775482267
Homepage URL
katsuo14@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
tsukinowa-cho, seta, otsu city, Shiga prefecture
Tel
0775482267
katsuo14@belle.shiga-med.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
| 2024 | Year | 02 | Month | 20 | 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
| 2022 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055813
