UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the study about the effectiveness of the amniocentesis for the threatened premature delivery
Title of the study (Brief title)	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	Yukiko Mikami
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Obstetrics and Gynecology
Address	1981 Kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3681
Email	ymikami@saitama-med.ac.jp

Public contact
Name of contact person	Yukiko Mikami
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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