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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006925
Receipt No. R000008176
Scientific Title Clinical significance of proteinuria without hypertension during pregnancy
Date of disclosure of the study information 2012/01/01
Last modified on 2014/06/22

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Basic information
Public title Clinical significance of proteinuria without hypertension during pregnancy
Acronym Clinical significance of proteinuria without hypertension during pregnancy
Scientific Title Clinical significance of proteinuria without hypertension during pregnancy
Scientific Title:Acronym Clinical significance of proteinuria without hypertension during pregnancy
Region
Japan

Condition
Condition Preeclampsia
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Prospective study on the risk of progression to preeclampsia among women with newly onset isolated proteinuria
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The risk of progression to preeclampsia among women with newly onset isolated proteinuria
Key secondary outcomes 1. The risk of progression to preeclampsia among women with newly onset hypertension alone
2. The comparison of clinical courses of women who initially presented with proteinuria alone, hypertension alone, and the both.
3. The characteristics of laboratory variables of participants in this study.

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 The participants are pregnant women who are managed at the Hokkaido University Hospital. Women who exhibit proteinuria alone, hypertension alone or the both are eligible and should fulfill all of following three conditions.
1. Antenatal care is given before 20 weeks of gestation.
2. Proteinuria or hypertension is detected first at and after 20 weeks of gestation.
3. Written informed consent is obtained before the participation in this study. If the participant is nonage, the informed consent is obtained from parent.
Key exclusion criteria 1. A pregnant woman who refuses to participate in this study.
2. A pregnant woman who has other complications.
3. A pregnant woman who is considered inappropriate for this study by researchers.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisanori Minakami
Organization Hokkaido University Graduate School of Medicine
Division name Department of Obstetrics, Reproductive and Developmental Medicine, Division of Pathophysiological Science
Zip code
Address N15W7, Kita-ku, Sapporo, 060-8638, Japan
TEL 011-706-6932
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Yamada
Organization Hokkaido University Hospital
Division name Department of Obstetrics
Zip code
Address N14W5, Kita-ku, Sapporo, 060-8648, Japan
TEL 011-706-5941
Homepage URL
Email taka0197@med.hokudai.ac.jp

Sponsor
Institute Department of Obstetrics, Reproductive and Developmental Medicine, Division of Pathophysiological Science, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Obstetrics, Reproductive and Developmental Medicine, Division of Pathophysiological Science, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2012 Year 01 Month 01 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
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2014 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information Multi institutional prospective study.

Management information
Registered date
2011 Year 12 Month 21 Day
Last modified on
2014 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008176

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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