UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047300 |
|---|---|
| Receipt number | R000053943 |
| Scientific Title | The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth |
| Date of disclosure of the study information | 2022/03/28 |
| Last modified on | 2022/03/28 12:24:33 |
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Basic information
Public title
The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Acronym
The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Scientific Title
The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Scientific Title:Acronym
The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Region
| Japan |
Condition
Condition
Cervical incompetency
Classification by specialty
| Obstetrics and Gynecology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The investigation of the efficacy of cervical cerclage for cervical incompetency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The analysis of factors involved in the successful cervical cerclage
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Pregnant women who underwent cerclage from 12 to 25 weeks gestation in four perinatal medical centers between January 2009 and December 2010
Key exclusion criteria
Prognosis unknown and multiple pregnant women
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shibata |
Organization
University of Occupational and Environmental Health
Division name
Department of Obstetrics and Gynecology
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-city, Fukuoka, JAPAN
TEL
093-603-1611
age-s@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shibata |
Organization
University of Occupational and Environmental Health
Division name
Department of Obstetrics and Gynecology
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-city, Fukuoka, JAPAN
TEL
093-603-1611
Homepage URL
age-s@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
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
University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi-k, Kitakyushu-city, Fukuoka, JAPAN
Tel
0936031611
age-s@med.uoeh-u.ac.jp
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
| 2022 | Year | 03 | Month | 28 | 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
114
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
WBC(/ul)
CRP(mg/dl)
Gestational weeks at cerclage
Pre-cerclage Cervical length(mm)
The rate of Prophylactic cerclage
The rate of Therapeutic cerclage
Blood loss of operation(g)
Operation time(min)
Post-cerclage Cervical length(mm)
Cervical length from suture to EOS(mm)
Hospitalization(day)
Duration of RIT use(day)
Pregnancy latency(day)
Management information
Registered date
| 2022 | Year | 03 | Month | 28 | Day |
Last modified on
| 2022 | 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=R000053943
