UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008938
Receipt number 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 11:22:46

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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 Obstetrics 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


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



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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010447


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name