UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010557 |
|---|---|
| Receipt number | R000012341 |
| Scientific Title | Amnioinfusion with ulinastatin to Chronic Abruption-Oligohydramnions Sequence |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2017/03/28 13:23:51 |
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Basic information
Public title
Amnioinfusion with ulinastatin to Chronic Abruption-Oligohydramnions Sequence
Acronym
Amnioinfusion with ulinastatin to Chronic Abruption-Oligohydramnions Sequence
Scientific Title
Amnioinfusion with ulinastatin to Chronic Abruption-Oligohydramnions Sequence
Scientific Title:Acronym
Amnioinfusion with ulinastatin to Chronic Abruption-Oligohydramnions Sequence
Region
| Japan |
Condition
Condition
Chronic Abruption-Oligohydramnions Sequence
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether free iron in amniotic fluid cavity is washed out by amnioinfusion with ulinastatin and fetal lung disorder is prevented or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We examine whether we could prevent or reduce the risk of neonatal lung disorder or not.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
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 |
Interventions/Control_1
We puncture amniotic fluid cavity with a needle through maternal abdomen guided by ultrasound and infuse saline solution with ulinastatin.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients prior to the 26th week of gestational age with placental abruption which genital bleeding last for more than 7 days, and complicated by oligohydramnion without the evidence of premature rupture of membrane are included.
Key exclusion criteria
Criteria for exclusion from the study include conditions of labor onset, clinical chorioamnionitis and non- reassuring fetal status.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Konishi |
Organization
Kyoto University, Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3269
konishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Kawasaki |
Organization
Kyoto University, Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3269
Homepage URL
kkaoru@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine
Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Kyoto University, Graduate School of Medicine
Obstetrics and Gynecology
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 21 | Day |
Last modified on
| 2017 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012341
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
