UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030063
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

* 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

Obstetrics 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 or person

Institute

Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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