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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040601
Receipt No. 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 2020/05/31

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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
Obsterics 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 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
Email 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
Email hqgyne@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email 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 Open public 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
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 31 Day
Last modified on
2020 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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