UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018883 |
|---|---|
| Receipt number | R000021845 |
| Scientific Title | Surveillance of HIV-infected pregnancy and establishment of guideline for prevention of HIV mother-to-child-transmission (MTCT) in Japan |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2018/05/15 19:53:25 |
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Basic information
Public title
Surveillance of HIV-infected pregnancy and establishment of guideline for prevention of HIV mother-to-child-transmission (MTCT) in Japan
Acronym
HIV-MTCT prevention project in japan
Scientific Title
Surveillance of HIV-infected pregnancy and establishment of guideline for prevention of HIV mother-to-child-transmission (MTCT) in Japan
Scientific Title:Acronym
HIV-MTCT prevention project in japan
Region
| Japan |
Condition
Condition
HIV
Classification by specialty
| Hematology and clinical oncology | Infectious disease | Obstetrics and Gynecology |
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveillance of HIV-infected pregnancy and establishment of guideline for prevention of HIV mother-to-child-transmission (MTCT) in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of HIV mother-to-child-transmission
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HIV-infected pregnancy
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsunekazu Kita |
Organization
Nara prefectural general medical center
Division name
Obstetrics & Gynecology
Zip code
Address
1-30-1,Hiramatsu,Nara city, Nara prefecture
TEL
0742-46-6001
obgy@nara-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Sugiura |
Organization
Nara prefectural general medical center
Division name
Obstetrics & Gynecology
Zip code
Address
1-30-1,Hiramatsu,Nara city, Nara prefecture
TEL
0742-46-6001
Homepage URL
http://hivboshi.org/index.html
atsushi7707@yahoo.co.jp
Sponsor or person
Institute
Research on HIV/AIDS
Institute
Department
Personal name
Funding Source
Organization
Research on HIV/AIDS
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
| 2015 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Surveillance of HIV-infected pregnancy and establishment of guideline for prevention of HIV mother-to-child-transmission (MTCT) in Japan
Management information
Registered date
| 2015 | Year | 09 | Month | 01 | Day |
Last modified on
| 2018 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021845
