UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030063
Receipt No. R000034326
Scientific Title The clinical trial concerned with selection of the suturing methods for uterine wound relating to uterine tissue oxygen saturation in cesarean section
Date of disclosure of the study information 2017/11/21
Last modified on 2018/05/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The clinical trial concerned with selection of the suturing methods for uterine wound relating to uterine tissue oxygen saturation in cesarean section
Acronym The clinical trial concerned with selection of the suturing methods in cesarean section
Scientific Title The clinical trial concerned with selection of the suturing methods for uterine wound relating to uterine tissue oxygen saturation in cesarean section
Scientific Title:Acronym The clinical trial concerned with selection of the suturing methods in cesarean section
Region
Japan

Condition
Condition Pregnant women over 36 weeks of gestation who will undergo the first cesarean section
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the tissue oxygen saturation and total hemoglobin index of the uterine wound in first cesarean section using examiner's finger-mounted tissue oximeter and compare with the different methods of uterine closure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the tissue oxygen saturation and total hemoglobin index of uterine wound between full thickness myometrial closure including the endometrial layer and myometrial closure excluding the endometrial layer
Key secondary outcomes To investigate the tissue oxygen saturation and total hemoglobin index compared between two groups as follows:
1. Closure at 1cm pitch versus closure at 2cm pitch in single-layer
2. Single-layer versus double-layer closure of lower uterine segment incision
3. The edge area of uterine wound versus the center of uterine wound
4. The lower side of uterine wound versus the upper side of uterine wound

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The full thickness myometrial closure including the endometrial layer (single interrupted suture)
Interventions/Control_2 The myometrial closure excluding the endometrial layer (single interrupted suture)
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 over 36 weeks of gestation and who will undergo the first cesarean section
Key exclusion criteria 1. Pregnant women who will undergo cesarean section under general anesthesia
2. Pregnant women who had cesarean section
3. Multiple pregnancy
4. Patients having cardiovascular disturbances or a dyspneic condition
5. Uterine incision method other than lower transverse section
6. Transverse fetal lie
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Uchida
Organization Hamamatsu University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2309
Email utty@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Uchida
Organization Hamamatsu University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2309
Homepage URL
Email utty@hama-med.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 浜松医科大学医学部附属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 21 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
2017 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 21 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 21 Day
Last modified on
2018 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.