UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040601 |
|---|---|
| Receipt number | R000046334 |
| Scientific Title | A study of uterine closure techniques in cesarean section |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2024/01/02 19:26:18 |
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Basic information
Public title
A study of uterine closure techniques in cesarean section
Acronym
A study of uterine closure techniques in cesarean section
Scientific Title
A study of uterine closure techniques in cesarean section
Scientific Title:Acronym
A study of uterine closure techniques in cesarean section
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of uterine suturing technique between continuous and interrupted closure of cesarean scar for the prevention of cesarean scar defect.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Residual myometrial thickness and the incidence of severe CSD 6-8 months after cesarean section.
Key secondary outcomes
1.The characteristics of participants
2.Total operation time in cesarean section
3.Total blood loss in cesarean section
4.The number of suture to close the cesarean scar in cesarean section
5.Fever or not after cesarean section
6.The value of CRP one day post cesarean section
7.The period of admission for cesarean section
8.Healing ratio in cesarean scar defect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Arm A; Double-layer closure by continuous uterine suturing technique of cesarean scar
Interventions/Control_2
Arm B; Double-layer closure by interrupted uterine suturing technique of cesarean scar
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
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women who will carry out cesarean section.
Key exclusion criteria
1.Women with myoma on the cesarean scar
2.Uterine anomaly
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Murakami |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu city, Shiga
TEL
077-548-2267
hqgyne@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shunichiro |
| Middle name | |
| Last name | Tsuji |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu city, Shiga
TEL
077-548-2267
Homepage URL
hqgyne@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu city, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2020 | Year | 05 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 25 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046334
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/02/09 | Study protocol.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
