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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004233
Receipt No. R000005089
Scientific Title Maternal endothelial function as a marker for predicting preeclampsia
Date of disclosure of the study information 2010/09/27
Last modified on 2012/09/27

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Basic information
Public title Maternal endothelial function as a marker for predicting preeclampsia
Acronym Predictive markers of preeclampsia
Scientific Title Maternal endothelial function as a marker for predicting preeclampsia
Scientific Title:Acronym Predictive markers of preeclampsia
Region
Japan

Condition
Condition pregnant women at high risk of preeclampsia
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to clarify the efficacy of Endo-PAT, a noninvasive endothelial function assessment device, as a predictive marker of preeclampsia in comparison with the other recognized markers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The occurrence of preeclampsia
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Age>40
Family history of hypertension or NIDDM, and preeclampsia
Pregnancy complicated with DM, hypertension, kidney disorder, and autoimmune disorders
Obesity (BMI>30)
Previous history of preeclampsia
A twin or multiple pregnancy
Key exclusion criteria Patients suffering from hemorrhage (e.g., hemophilia, and capillary fragility)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Konishi
Organization Kyoto University Graduate School of Medicine
Division name Gynecology and Obstetrics
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku, Kyoto 606-8507, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Graduate School of Medicine
Division name Gynecology and Obstetrics
Zip code
Address
TEL 075-751-3269
Homepage URL
Email

Sponsor
Institute Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science & Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 27 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
2010 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information Prospective study
Receiver operating characteristic analysis for evaluating predictive markers of preeclampsia using RH-PAT index, and maternal blood concentration of sFlt-1, Endoglin, PlGF, inhibin A, and activin A collected at 1st, 2nd and 3rd trimeter.

Management information
Registered date
2010 Year 09 Month 19 Day
Last modified on
2012 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005089

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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