UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034406
Receipt number R000039235
Scientific Title retrospective study of anesthetic management in cesarean section cases
Date of disclosure of the study information 2018/10/09
Last modified on 2023/05/02 19:40:21

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Basic information

Public title

retrospective study of anesthetic management in cesarean section cases

Acronym

retrospective study of anesthetic management in cesarean section cases

Scientific Title

retrospective study of anesthetic management in cesarean section cases

Scientific Title:Acronym

retrospective study of anesthetic management in cesarean section cases

Region

Japan


Condition

Condition

parturients

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To review anesthetic management of cesarean section in Tokyo Women's Medical University Hospital and to investigate perioperative or perinatal outcome

Basic objectives2

Others

Basic objectives -Others

To improve our anesthetic management in the future

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

perioperative or postoperative status of the patient

Key secondary outcomes

maternal blood sampling, the course of anesthesia administration, the hemodynamic state during the operation, the state of the patient during the operation, the state of the patient after the operation, the state of the newborn


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

parturients who had a cesarean operation application at Tokyo Women's Medical University Hospital between January 2014 and August 2019

Key exclusion criteria

parturients who were younger than 20 years of age, parturient who delivered by vaginal delivery or instrument delivery after application of cesarean section, parturients who are judged inappropriate as research subjects

Target sample size

1400


Research contact person

Name of lead principal investigator

1st name Yasuko
Middle name
Last name Nagasaka

Organization

Tokyo Women's Medical University

Division name

Department of Anesthesiology

Zip code

1628666

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Email

moz@twmu.ac.jp


Public contact

Name of contact person

1st name Risa
Middle name
Last name Fukushima

Organization

Tokyo Women's Medical University

Division name

Department of Anesthesiology

Zip code

1628666

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

0333538111

Homepage URL


Email

rfukushima-twmu@umin.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Women's Medical University

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

Tokyo Women's Medical University

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

Tel

0333538111

Email

ohta.megumi@twmu.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



Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 09 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

2018 Year 10 Month 01 Day

Date of IRB

2019 Year 09 Month 30 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2030 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

maternal blood sampling, the course of anesthesia administration, the hemodynamic state during the operation, the state of the patient during the operation, the state of the patient after the operation, the state of the newborn


Management information

Registered date

2018 Year 10 Month 08 Day

Last modified on

2023 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039235


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name