UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027396 |
|---|---|
| Receipt number | R000031391 |
| Scientific Title | the study about the effectiveness of the amniocentesis for the threatened premature delivery |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2018/11/17 17:38:16 |
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Basic information
Public title
the study about the effectiveness of the amniocentesis for the threatened premature delivery
Acronym
the study about the effectiveness of the amniocentesis for the threatened premature delivery
Scientific Title
the study about the effectiveness of the amniocentesis for the threatened premature delivery
Scientific Title:Acronym
the study about the effectiveness of the amniocentesis for the threatened premature delivery
Region
| Japan |
Condition
Condition
threatened premature delivery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze the inflammation related substances in amniotic fluid such as cytokine, gluose, granulocyte elastase and differential leukocyte count by amniocentesis and investigate the effective therapy for preventing the premature delivery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the inflammation related substances and the therapeutic effect of the threatened premature delivery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
When we recognize the high levels of the inflammations related substances in the amniotic fluid, we may use the antibiotic medicine for more long term than usually.
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
The pregnant women who diagnosed threatened premature delivery (more than 22 weeks of gestation, less than 36 weeks of gestation)
Key exclusion criteria
The case of the clinical chorioamnionitis, malformation of the fetus, multiple pregnancy, placenta previa, low set of placenta, the cases who are difficult to amniocentesis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko Mikami |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3681
ymikami@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Mikami |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3681
Homepage URL
ymikami@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
| 2017 | Year | 05 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2018 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031391
