UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040066
Receipt number R000045678
Scientific Title Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension during cesarean section
Date of disclosure of the study information 2020/04/15
Last modified on 2023/10/09 10:46:26

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Basic information

Public title

Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension during cesarean section

Acronym

Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension

Scientific Title

Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension during cesarean section

Scientific Title:Acronym

Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension

Region

Japan


Condition

Condition

cesarean section

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effect of circulatory management using esCCO as an indicator on the prevention of the appearance of hypotension.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Compare the frequency and time of hypotension (systolic blood pressure less than 100 mmHg and mean blood pressure less than 65 mmHg)

Key secondary outcomes

Comparison of the vasopressor drug, infusion volume, neonatal apgar score and pH levels between the two groups


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

one group to start hypotension treatment using noninvasive blood pressure measurement to predict the appearance of hypotension .

Interventions/Control_2

and one group to start treatment using esCCO in addition to noninvasive blood pressure measurement to predict the appearance of hypotension .

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

Patients who meet all of the following criteria

1. patients waiting for cesarean section
2. anesthesia method is spinal combined epidural anesthesia
3. over 20 years old
4. patients who have given written consent

Key exclusion criteria

Patients who are deemed inappropriate to participate in the study due to serious complications.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Yumoto

Organization

Fukuoka birth clinic

Division name

department of obstetrics

Zip code

819-0006

Address

3-18-21 Meinohamaekiminami, Nishi-ku, Fukuoka

TEL

092-883-0530

Email

keny@kuaccm.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name kazuhiro
Middle name
Last name shirozu

Organization

kyushu university Hospital

Division name

Anesthesia and critical care medicine

Zip code

812-8582

Address

3-1-1 maidashi, higashi-ku, Fukuoka

TEL

092-642-5714

Homepage URL


Email

shirozu.kazuhiro.334@m.kyushu-u.ac.jp


Sponsor or person

Institute

Fukuoka birth clinic

Institute

Department

Personal name



Funding Source

Organization

Kyushu university hospital

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

Center for Clinical and Translational Research(CCTR)

Address

3-1-1 maidashi, higashi-ku, Fukuoka

Tel

0924079539

Email

byskenkyu@jimu.kyushu-u.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

福岡県


Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 15 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

Completed

Date of protocol fixation

2020 Year 03 Month 30 Day

Date of IRB

2020 Year 04 Month 07 Day

Anticipated trial start date

2020 Year 04 Month 15 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 04 Month 06 Day

Last modified on

2023 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045678


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name