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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008938
Receipt No. R000010447
Scientific Title Study of renal damages in patients with pregnancy induced-hypertension syndrome.
Date of disclosure of the study information 2012/09/18
Last modified on 2012/09/18

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Basic information
Public title Study of renal damages in patients with pregnancy induced-hypertension syndrome.
Acronym Study of renal damages in patients with pregnancy induced-hypertension syndrome.
Scientific Title Study of renal damages in patients with pregnancy induced-hypertension syndrome.
Scientific Title:Acronym Study of renal damages in patients with pregnancy induced-hypertension syndrome.
Region
Japan

Condition
Condition pregnancy induced hypertension
Classification by specialty
Nephrology Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate multiple renal impairment associated with pregnancy induced-hypertension syndrome in pregnant women through single center cohort study
Basic objectives2 Others
Basic objectives -Others Pathological severity of renal impairment in variable subclass and severity of pregnancy induced-hypertension syndrome will be studied by principally focusing on the functional insufficiency of renal tubules.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes total and renal tubular urine protein during the disease period of pregnancy induced-hypertension syndrome
Key secondary outcomes blood and urine biochemical parameters including Cystatin-C, L-FABP, NGAL and Kim-1

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 We take blood and urine samples more frequently than normal pregnant woman
Interventions/Control_2 We take blood and urine samples more frequently than normal pregnant woman
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria The pregnant woman who has the past of PIH.The pregnant woman whose family has past of PIH.Advanced age pregnant woman 40 years or older.Pregnant woman of the first childbirth.
Key exclusion criteria The pregnant woman who has chronic high blood pressure before the pregnancy.Pregnant woman with the past of the chronic nephritis.Pregnant woman of the multiple pregnancy.Pregnant woman having HELLP syndrome.Pregnant woman having APS.Pregnant woman having Abnormality of the solidification inhibitor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinpei Okazaki
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Nephrology and Hypertension
Zip code
Address 1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL 049-228-3604
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinpei Okazaki
Organization saitama medical center,saitama medical university
Division name Department of nephrology and hypertension
Zip code
Address 1981 tsujidochou,kamoda,kawagoe,saitama,japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Gynecology and Obstetrics, Saitama Medical Center, Saitama Medical University
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 埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 18 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 Preinitiation
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2013 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 11 Month 30 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 09 Month 18 Day
Last modified on
2012 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010447


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