UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037771 |
|---|---|
| Receipt number | R000043070 |
| Scientific Title | Development of neo-self antibody research for recurrent pregnancy loss and obstetric complications |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2021/11/04 09:03:01 |
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Basic information
Public title
Development of neo-self antibody research for recurrent pregnancy loss and obstetric complications
Acronym
Development of neo-self antibody research for recurrent pregnancy loss and obstetric complications
Scientific Title
Development of neo-self antibody research for recurrent pregnancy loss and obstetric complications
Scientific Title:Acronym
Development of neo-self antibody research for recurrent pregnancy loss and obstetric complications
Region
| Japan |
Condition
Condition
Recurrent pregnancy loss, obstetric complications, sterility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of association between beta2GPI/HLA-DR7 antibody and recurrent pregnancy loss, obstetric complications, and sterility. Development of measurement and therapy methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
A caste-control study evaluate whether beta2GPI/HLA-DR7 antibody is associated with recurrent pregnancy loss, obstetric complications, or sterility
Key secondary outcomes
A cohort study for pregnant women (<21GW) evaluate whether beta2GPI/HLA-DR7 antibody is associated with obstetric complications
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Recurrent pregnancy loss
2) FGR
3) HDP
4) Preterm delivery
5) Sterility
6) Normal delivery without 1)-4)
7) Autoimmune disease
obtaining written informed consent in 1)-7)
Key exclusion criteria
1) Less than 18 years, or more than 45 years old
2) Inappropriate subjects
3) Multiple pregnancy or pregnancy with fetal anomaly
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Yamada |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho Chuo-ku, Kobe, Japan
TEL
0783826000
yhideto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tanimura |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho Chuo-ku, Kobe, Japan
TEL
0783826000
Homepage URL
taniken@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Department of Obstetrics & Gynecology
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical Translational Research Center
Address
7-5-2 Kusunoki-cho Chuo-ku, Kobe, Japan
Tel
078-382-6669
kansatsu@med.kobe-u.ac.jp
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
| 2019 | Year | 08 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is in progress.
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043070
| 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 |
