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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030347
Receipt No. 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 2017/12/11

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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
Obsterics 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
Middle name
Last name Shigeru Saito
Organization Toyama University Hospital
Division name Obstetrics and Gynecology
Zip code
Address 2630 Sugitani, Toyama
TEL 076-434-7355
Email s30saito@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Arihiro Shiozaki
Organization Toyama University Hospital
Division name Obstetrics and Gynecology
Zip code
Address 2630 Sugitani, Toyama
TEL 076-434-7357
Homepage URL
Email s33shio@med.u-toyama.ac.jp

Sponsor
Institute Obstetrics and Gynecolgy, Toyama University Hospital
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2017 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034655

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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