UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021174 |
|---|---|
| Receipt number | R000023708 |
| Scientific Title | Trial for Manual Vacuum Aspirarion(MVA)kit in patients with reccurent pregnancy loss |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2016/03/01 16:53:57 |
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Basic information
Public title
Trial for Manual Vacuum Aspirarion(MVA)kit in patients with reccurent pregnancy loss
Acronym
Trial for MVA kit in patients with reccurent pregnancy loss
Scientific Title
Trial for Manual Vacuum Aspirarion(MVA)kit in patients with reccurent pregnancy loss
Scientific Title:Acronym
Trial for MVA kit in patients with reccurent pregnancy loss
Region
| Japan |
Condition
Condition
Recurrent pregnancy loss
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Trial for confirmation usefulness of MVA in the recurrent pregnancy loss patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Neccesity or not of the artificial re-curettage
Key secondary outcomes
Volume of bleeding, scaling for pain, dose of anti-pain drug, assesment of physical and mental post-operation period in one month, neccesity or not of the drug use for retention, complete of the villous karyotype analysis.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
patient with recurent pregnancy loss diagnosed missed abortion
over 20 years old
The pregnant woman that an agreement is provided in a document about this reserch
Key exclusion criteria
complete abortion
no hope for surical abortion
suspect hydation mole
over 12 gestation week
Doctor admited inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamao Kitaori |
Organization
Nagoya City Uninersity Hospital
Division name
Obsterics and Gynecology
Zip code
Address
Kawasumi-1,Mizuho-cho, Mizuho-ku, Nagoya,Aichi, Japan
TEL
052-853-8241
tama-og@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamao Kitaori |
Organization
Nagoya City Uninersity Hospital
Division name
Obsterics and Gynecology
Zip code
Address
Kawasumi-1,Mizuho-cho, Mizuho-ku, Nagoya,Aichi, Japan
TEL
052-853-8241
Homepage URL
tama-og@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City Uninersity Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Uninersity Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 02 | Month | 24 | 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
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational, prospective study
All the members who were equal to criteria for selection in the patients who consulted our facilities on February 28, 2017 from March 1, 2016
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023708
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
