Unique ID issued by UMIN | UMIN000030063 |
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Receipt number | 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 09:11:01 |
The clinical trial concerned with selection of the suturing methods for uterine wound relating to uterine tissue oxygen saturation in cesarean section
The clinical trial concerned with selection of the suturing methods in cesarean section
The clinical trial concerned with selection of the suturing methods for uterine wound relating to uterine tissue oxygen saturation in cesarean section
The clinical trial concerned with selection of the suturing methods in cesarean section
Japan |
Pregnant women over 36 weeks of gestation who will undergo the first cesarean section
Obstetrics and Gynecology |
Others
NO
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
Efficacy
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
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
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Maneuver |
The full thickness myometrial closure including the endometrial layer (single interrupted suture)
The myometrial closure excluding the endometrial layer (single interrupted suture)
20 | years-old | <= |
Not applicable |
Female
Pregnant women over 36 weeks of gestation and who will undergo the first cesarean section
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
20
1st name | |
Middle name | |
Last name | Toshiyuki Uchida |
Hamamatsu University School of Medicine
Department of Obstetrics and Gynecology
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
053-435-2309
utty@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Toshiyuki Uchida |
Hamamatsu University School of Medicine
Department of Obstetrics and Gynecology
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
053-435-2309
utty@hama-med.ac.jp
Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine
Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine
Self funding
NO
浜松医科大学医学部附属病院(静岡県)
2017 | Year | 11 | Month | 21 | Day |
Unpublished
Open public recruiting
2017 | Year | 11 | Month | 13 | Day |
2017 | Year | 11 | Month | 21 | Day |
2018 | Year | 10 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 01 | Month | 31 | Day |
2017 | Year | 11 | Month | 21 | Day |
2018 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034326
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