UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009068 |
|---|---|
| Receipt number | R000010613 |
| Scientific Title | Assessment of validity and safety in Enoxaparin administration soon after cesarean section. |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2014/03/25 11:43:21 |
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Basic information
Public title
Assessment of validity and safety in Enoxaparin administration soon after cesarean section.
Acronym
Clinical assessment of Enoxaparin administration soon after cesarean section.
Scientific Title
Assessment of validity and safety in Enoxaparin administration soon after cesarean section.
Scientific Title:Acronym
Clinical assessment of Enoxaparin administration soon after cesarean section.
Region
| Japan |
Condition
Condition
venous thromboembolism (VTE)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if the prevention against venous thromboembolism after cesarean section by Enoxaparin administration has less adverse and more preferable effects compared to non-fractional heparin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence rate of VTE and other complications following cesarean section.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administrated group of unfractionated heparin calcium (Mochida)
Interventions/Control_2
administrated group of Enoxaparin (Clexane)
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
Women who delivered a baby/babies by cesarean section.
Key exclusion criteria
thrombocytopenia,
acute bacterial endocarditis
renal dysfunction (creatinine clearance less than 50 mL/min)
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Itoh |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2309
hitou-endo@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Itoh |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2309
Homepage URL
hitou-endo@umin.ac.jp
Sponsor or person
Institute
Obstetrics and Gynecology, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Obstetrics and Gynecology, Hamamatsu University 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
浜松医科大学医学部付属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 09 | 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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 09 | Day |
Last modified on
| 2014 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010613
