UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050216 |
|---|---|
| Receipt number | R000057186 |
| Scientific Title | Establishment of diagnostic method for placental disease using SMI |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2023/02/02 11:26:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Involvement in various diseases of the placenta during pregnancy and examination of diagnostic methods using fine ultrasound Doppler
Acronym
Examination of diagnostic methods for placental disease during pregnancy
Scientific Title
Establishment of diagnostic method for placental disease using SMI
Scientific Title:Acronym
EPDS test
Region
| Japan |
Condition
Condition
Fetal growth restriction, hypertensive syndrome of pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will introduce SMI ultrasonography to prenatal checkups, create a reference (evaluation criteria) for normal placenta, and define SMI ultrasound pathological images specific to various placental abnormalities. Furthermore, in a prospective cohort study, SMI ultrasonographic screening during pregnancy will be performed to verify the accuracy of detection of placental abnormalities. Through this research, we hope to visualize the placental formation process with unprecedented accuracy and establish an early diagnosis method for placental diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incorporating placental SMI in prenatal checkups at our hospital and ultrasonography for patients hospitalized under management at our hospital. After delivery, the placenta is submitted for pathological examination to obtain microscopic findings. By comparing placental ultrasonographic findings with pathological findings, the effects of the placenta on diseases thought to be caused by the placenta, such as fetal growth restriction, will be examined, and diagnostic methods for placental diseases during pregnancy will be established.
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
The subjects were pregnant women who underwent prenatal checkups at our hospital and delivered at our hospital. By comparing cases of fetal growth restriction caused by the placenta and umbilical cord with those without fetal growth restriction (e.g., threatened premature birth), placental and umbilical cord abnormalities that cause fetal growth restriction are included in placental pathological findings. Consider the impact.
Key exclusion criteria
Among the cases of fetal growth restriction, cases considered to be caused by morphological abnormalities of the fetus and those with known causes such as multiple births are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Hasegawa |
Organization
St.Marianna university
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugo, Miyamae Ward, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
dr.hasejun@outlook.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Furuya |
Organization
St.Marianna university
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugo, Miyamae Ward, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
Homepage URL
n3furuya@marianna-u.ac.jp
Sponsor or person
Institute
St.marianna university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.marianna university
Address
2-16-1 Sugo, Miyamae Ward, Kawasaki City, Kanagawa Prefecture
Tel
044-977-8111
n3furuya@marianna-u.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
| 2023 | Year | 02 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
Management information
Registered date
| 2023 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057186
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
