UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001306 |
|---|---|
| Receipt number | R000001583 |
| Scientific Title | Double blined rondmised control trial of the effect of folate preventing miscarriage in unexplained recurrent miscarriages. |
| Date of disclosure of the study information | 2008/08/08 |
| Last modified on | 2014/05/30 14:56:04 |
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Basic information
Public title
Double blined rondmised control trial of the effect of folate preventing miscarriage in unexplained recurrent miscarriages.
Acronym
RCT of folate in recurrent miscarriage
Scientific Title
Double blined rondmised control trial of the effect of folate preventing miscarriage in unexplained recurrent miscarriages.
Scientific Title:Acronym
RCT of folate in recurrent miscarriage
Region
| Japan |
Condition
Condition
unexplained recurrent miscarriage
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to study whethre folate supplementation can prevent further miscarriage in recurrnt miscarriage patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
live birth rate
Key secondary outcomes
folate level before pregnancy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
folate 5mg
Interventions/Control_2
placebo
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
patients without explained causes of recurrent miscarriage
Key exclusion criteria
abnormal chromosome in either partner, congenital uterine anomaly, antiphospholipid antibody
patients with complications who are treated with drugs
patients who have any supplement
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi Sugiura |
Organization
Nagoya City University Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
Kawasumi 1, Mizuho-ku, Nagoya, Aichi
TEL
052-851-5511
og.mym@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Sugiura |
Organization
Nagoya City University Medical School
Division name
Obstetrics and Gunecology
Zip code
Address
Kawasumi 1, Mizuho-ku, Nagoya
TEL
052-851-5511
Homepage URL
og.mym@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Wealfare
Organization
Division
Category of Funding Organization
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
名古屋市立大学病院
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2007 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 08 | Day |
Last modified on
| 2014 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001583
