UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037185
Receipt number R000042378
Scientific Title Retrospective study of anesthetic management for cesarean and vaginal deliveries with intra-uterus fetal death
Date of disclosure of the study information 2019/06/26
Last modified on 2024/04/16 17:49:22

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Basic information

Public title

Retrospective study of anesthetic management for stillbirth

Acronym

Retrospective study of anesthetic management for stillbirth

Scientific Title

Retrospective study of anesthetic management for cesarean and vaginal deliveries with intra-uterus fetal death

Scientific Title:Acronym

Retrospective study of anesthetic management for intra-uterus fetal death cases

Region

Japan


Condition

Condition

intra-uterus fetal death

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To consider the characteristics of deliveries that had been diagnosed with intrauterine fetal death prior to cesarean or vaginal deliveries, and to extract the main points of anesthesia management and the maternal outcomes.

Basic objectives2

Others

Basic objectives -Others

To improve quality of anesthesia

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

maternal complications

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Female diagnosed with intra-uterus fetal death

Key exclusion criteria

None

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Ozaki

Organization

Tokyo Women's Medical University

Division name

Department of Anesthesiology

Zip code

1628666

Address

8-1 Kawadacho Shinjyuku-ku Tokyo

TEL

0333538111

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 Kawadacho Shinjyuku-ku Tokyo

TEL

0333538111

Homepage URL


Email

risaofukushim@gmail.com


Sponsor or person

Institute

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 Kawadacho Shinjyuku-ku Tokyo

Tel

0333538111

Email

rinri.bm@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

2019 Year 06 Month 26 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

Delay expected

Results Delay Reason

longer time to collect data than expected

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

Terminated

Date of protocol fixation

2019 Year 01 Month 07 Day

Date of IRB

2019 Year 01 Month 07 Day

Anticipated trial start date

2019 Year 01 Month 07 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective study


Management information

Registered date

2019 Year 06 Month 26 Day

Last modified on

2024 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name