UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030347 |
|---|---|
| Receipt number | R000034655 |
| Scientific Title | First-trimester maternal factors and biomarker screening for preeclampsia: Asia-wide study |
| Date of disclosure of the study information | 2017/12/11 |
| Last modified on | 2022/12/15 12:09:25 |
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Basic information
Public title
First-trimester maternal factors and biomarker screening for preeclampsia: Asia-wide study
Acronym
Asia-wide study for preeclampsia
Scientific Title
First-trimester maternal factors and biomarker screening for preeclampsia: Asia-wide study
Scientific Title:Acronym
Asia-wide study for preeclampsia
Region
| Japan |
Condition
Condition
Preeclamsia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify a high proportion of pregnancies at high-risk for early onset preeclampsia using a combination of maternal demographic characteristics, including medical and obstetric history, uterine artery pulsatility index, mean arterial pressure and maternal serum placental growth factor at 11-13 weeks of gestation.
Basic objectives2
Others
Basic objectives -Others
To get a fundamental data for screening of early onset preeclampsia
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Uterine artery pulsatility index (UtAPI), maternal serum placental growth factor (PlGF)
Key secondary outcomes
Mean arterial blood pressure (MAP), medical and obsteric history
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
Singleton pregnancy, 11+0 to 13+6 weeks of gestation
Key exclusion criteria
Large fetal anomaly, multiple pregnancy, intrauterine fetal death
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Saito |
Organization
Toyama University Hospital
Division name
Obstetrics and Gynecology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7355
s30saito@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Arihiro |
| Middle name | |
| Last name | Shiozaki |
Organization
Toyama University Hospital
Division name
Obstetrics and Gynecology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7357
Homepage URL
s33shio@med.u-toyama.ac.jp
Sponsor or person
Institute
Obstetrics and Gynecolgy, Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Clinical Laboratory, Ritz Medical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital
Address
2630 Sugitani, Toyama 930-0194
Tel
0764347357
s33shio@med.u-toyama.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
富山大学病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
maternal risk factors,
mean arterial blood pressure,
uterine artery pulsatility index,
maternal serum placental growth factor
Management information
Registered date
| 2017 | Year | 12 | Month | 11 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034655
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
