UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001871 |
|---|---|
| Receipt number | R000002253 |
| Scientific Title | Verification of the efficacy of intravaginal ulinastatin administration in patients with cervical shortening |
| Date of disclosure of the study information | 2009/04/15 |
| Last modified on | 2012/08/26 01:08:21 |
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Basic information
Public title
Verification of the efficacy of intravaginal ulinastatin administration in patients with cervical shortening
Acronym
Intra vaginal ulinastatin administration in cervical shortening (RCT)
Scientific Title
Verification of the efficacy of intravaginal ulinastatin administration in patients with cervical shortening
Scientific Title:Acronym
Intra vaginal ulinastatin administration in cervical shortening (RCT)
Region
| Japan |
Condition
Condition
Pregnant women with subclinical infection and cervical length 25 mm as diagnosed by transvaginal ultrasonography in a maternity health examination conducted during the second trimester of pregnancy (between week 16 day 0 and week 26 day 6 of gestation)
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of intravaginal ulinastatin in the prevention of preterm delivery in comparison to placebo in pregnant women in the second trimester of pregnancy diagnosed with subclinical infection and short cervix by transvaginal ultrasonography. Safety of this therapy will also be compared in the same way as efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Gestational week of delivery
Neonatal mortality rate
Neonatal morbidity
Key secondary outcomes
Percentage of patients using a tocolytic agent (ritodrine hydrochloride preparation, magnesium sulfate preparation)
Mean birth weight
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group administered intravaginal ulinastatin
Interventions/Control_2
Group administered placebo
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
(2) Cervical length less than 25.0 mm as diagnosed by transvaginal ultrasonography
(3) Pregnant women testing positive for subclinical infection*1 who do not have infection that could potentially determine the mode of delivery (such as HIV, HSV, or condyloma, etc.)
(4) Patients who have voluntarily provided written consent to participate in this trial, after having been thoroughly briefed, and informed of the nature of the trial (if the patient is under 20 years old, written consent must be obtained from the spouse (if the spouse is younger than 20 years old) or parent of the minor)
(5) Patients with stable functionality of major organs, confirmed by meeting the following laboratory test standards:
1)White blood cell count more than 3,000/mm3, less than 20,000/mm3
2) Platlet count more than 50,000/mm3
3) Hemoglobin more than 8.0g/dL
4)AST (GOT) <2.5 times upper limit of standard level of each test center
5) ALT (GPT) <2.5 times upper limit of standard level of each test center
6) BUN less than 25 mg/dL
7) Serum creatinine less than 2 mg/dL
Key exclusion criteria
(1) Multiple pregnancy involving more than 3 fetuses
(2) Placenta previa
(3) Premature separation of normally implanted placenta
(4) Serious fetal abnormality
(5) Patients in whom fetal well-being cannot be confirmed
(6) Patients who previously underwent cervical cerclage during current pregnancy
(7) Patients with signs of threatened premature delivery*2
(8) Patients with complications of psychiatric disease or psychiatric symptoms whose participation in the trial is judged to be infeasible
(9) Other patients judged to be ineligible by attending physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Okai |
Organization
Dept Obstetrics and Gynecology, Showa University
Division name
Obstetrics and Gynecology
Zip code
Address
1-5-8 Hatanodai, Shinagawa, Tokyo,142-8555, JAPAN
TEL
03-3784-8000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio SHINOZUKA |
Organization
Showa University
Division name
Obstetrics anc Gynecology
Zip code
Address
1-5-8 Hatanodai, Shinagawa, Tokyo,142-8555, JAPAN
TEL
03-3784-8000
Homepage URL
http://square.umin.ac.jp/topp
shinoz-tky@umin.ac.jp
Sponsor or person
Institute
Japan Organization of Prevention of Preterm Delivery
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare: Multidisciplinary Research Project on Children and Family
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
http://square.umin.ac.jp/topp
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
| 2005 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 02 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 10 | Day |
Last modified on
| 2012 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002253
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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