UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013900 |
|---|---|
| Receipt number | R000016206 |
| Scientific Title | Outcome of pregnancy women exhibit a reduced antithrombin activity |
| Date of disclosure of the study information | 2014/05/10 |
| Last modified on | 2018/11/26 15:01:18 |
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Basic information
Public title
Outcome of pregnancy women exhibit a reduced antithrombin activity
Acronym
Outcome of pregnancy with PIATD
Scientific Title
Outcome of pregnancy women exhibit a reduced antithrombin activity
Scientific Title:Acronym
Outcome of pregnancy with PIATD
Region
| Japan |
Condition
Condition
The pregnancy women exhibit a reduced antithrombin activity
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective study was performed to characterize
the outcome of pregnancy women exhibit a reduced antithrombin activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The risk of pregnancy-induced hypertension and HELLP syndrome, the frequency of abnormalities in blood examination.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
After receiving a full explanation upon participation in this study, patients with documented consent was obtained
Key exclusion criteria
Patients principal investigator was deemed inappropriate as a subject
Target sample size
100
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
Zip code
Address
Kita-ku N15 W7, Sapporo 060-8638, Japan
TEL
011-706-6051
minasho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Morikawa |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Obstetrics
Zip code
Address
Kita-ku N15 W7, Sapporo 060-8638, Japan
TEL
011-706-6051
Homepage URL
mmamoru@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 05 | Month | 10 | 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
| 2014 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the patients according to the following, Guidelines for obstetrical practice in Japan: Japan Society of Obstetrics and Gynecology (JSOG) and Japan Association of Obstetricians and Gynecologists (JAOG) 2011 edition. Minakami H, et. al. ; Japan Society of Obstetrics and Gynecology; Japan Association of Obstetricians and Gynecologists. J Obstet Gynaecol Res. 2011 Sep;37(9):1174-97
Management information
Registered date
| 2014 | Year | 05 | Month | 07 | Day |
Last modified on
| 2018 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016206
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/09/09 | [No.013-0144]【140130承認】.zip |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/09/09 | ■PIATD妊婦研究 調査票.fmp12 |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/09/09 | ■PIATD妊婦研究 調査票 5施設統合.fmp12 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/16206
