UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020013 |
|---|---|
| Receipt number | R000023103 |
| Scientific Title | Low-dose aspirin for reduction in preeclampsia risk in high-risk women in Japan. |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2022/12/07 12:52:01 |
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Basic information
Public title
Low-dose aspirin for reduction in preeclampsia risk in high-risk women in Japan.
Acronym
Low-dose aspirin for reduction in preeclampsia risk
Scientific Title
Low-dose aspirin for reduction in preeclampsia risk in high-risk women in Japan.
Scientific Title:Acronym
Low-dose aspirin for reduction in preeclampsia risk
Region
| Japan |
Condition
Condition
preeclampsia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect of low-dose aspirin on the incidence of preeclampsia in high-risk women
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of preeclampsia in high-risk women(previous preeclampsia,chronic hypertension,diabetes,autoimmune disease,blood pressure>130/80 at the first visit and BMI greater than 35)
Key secondary outcomes
the incidence of severe preeclampsia,preterm labor and fetal growth restriction in high-risk women
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
initiation of low-dose aspirin started from 12 to 16 weeks gestation and terminated below 28 weeks gestation
Interventions/Control_2
no initiation of low-dose aspirin to control
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
| 12 | weeks-old | <= |
Age-upper limit
| 28 | weeks-old | > |
Gender
Female
Key inclusion criteria
women who first visit before 16weeks gestation at our center and meet a criterion for the following lists
1 previous preeclampsia
2 chronich hypertension
3 diabetes
4 autoimmune disease
5 blood pressure>130/80 at the first visit
6 BMI greater than 35
Key exclusion criteria
1 multiple pregnancy
2 non-Japanease
3 low-dose aspirin initiated under 12 weeks'gestation for other reason
4 women who are out of sympathy with a plan
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruna Kawaguchi |
Organization
Osaka Medical Center and Research Institute for Maternal and Child Health
Division name
the Department of Maternal Fetal Medicine
Zip code
Address
840 Murodocho Izumi city,Osaka
TEL
0725-56-1220
haruna@mch.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruna Kawaguchi |
Organization
Osaka Medical Center and Research Institute for Maternal and Child Health
Division name
the Department of Maternal Fetal Medicine
Zip code
Address
840 Murodocho Izumi city,Osaka
TEL
0725-56-1220
Homepage URL
haruna@mch.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center and Research Institute for Maternal and Child Health
Institute
Department
Personal name
Funding Source
Organization
self
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
| 2015 | Year | 12 | 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
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023103
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
