UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056484 |
|---|---|
| Receipt number | R000064476 |
| Scientific Title | Research for the best suture method to prevent thinning of the myometrial incision during cesarean section. |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/12 20:45:17 |
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Basic information
Public title
A comparative study of one-layer versus two-layer sutures with barbed sutures for cesarean section: a randomized controlled trial.
Acronym
A comparative study of one-layer versus two-layer sutures with spinous sutures for cesarean section: RCT
Scientific Title
Research for the best suture method to prevent thinning of the myometrial incision during cesarean section.
Scientific Title:Acronym
Research for the best suture method to prevent thinning of the myometrial incision during cesarean section.
Region
| Japan |
Condition
Condition
Cesarean section
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the 6 months postoperative myometrial thickness of a single layer suture and two layers of continuous suture using barbed suture in the first cesarean section.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of residual myometrial thickness at 6 months postoperatively for first cesarean section with one or two layers of myometrium sutured.
Key secondary outcomes
Operative time, Intraoperative bleeding, Wound infection, 6 month postoperative dysmenorrhea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
single layer barbed sutures during cesarean section
Interventions/Control_2
double layer barbed sutures during cesarean section
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women 18 years of age or older undergoing first cesarean section at the Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital Department of Obstetrics and Gynecology
Key exclusion criteria
After onset of labor, emergency cesarean section, Pregnant women who have undergone a myomectomy procedure other than a transverse incision in the lower uterine body, Pregnant women who did not consent to the study, who deemed inappropriate for research by researchers
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tsuda |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Division name
Department of obstetrics and gynecology
Zip code
4538511
Address
3-35, Michishita-cho, Nakamura-ku, Nagoya City, Aichi Prefecture
TEL
0524815111
hirotty7099@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tsuda |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Division name
Department of obstetrics and gynecology
Zip code
4538511
Address
3-35, Michishita-cho, Nakamura-ku, Nagoya City, Aichi Prefecture
TEL
0524815111
Homepage URL
hirotty7099@yahoo.co.jp
Sponsor or person
Institute
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Address
3-35, Michishita-cho, Nakamura-ku, Nagoya City, Aichi Prefecture
Tel
0524815111
rinri@nagoya-1st.jrc.or.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
日本赤十字社愛知医療センター名古屋第一病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064476
