UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004233 |
|---|---|
| Receipt number | 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 09:20:52 |
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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
| Obstetrics 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
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
Sponsor or person
Institute
Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005089
