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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027396
Receipt No. 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

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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
Obsterics 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
Email 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
Email ymikami@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031391

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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