UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006925 |
|---|---|
| Receipt number | 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 07:59:05 |
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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
| Obstetrics 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
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
taka0197@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Obstetrics, Reproductive and Developmental Medicine, Division of Pathophysiological Science, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008176
