UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031273
Receipt number R000013593
Scientific Title The study of inferior vena cava compression by pregnant uterus on venous return and epidural plexus
Date of disclosure of the study information 2018/02/14
Last modified on 2022/09/05 16:05:31

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Basic information

Public title

The study of inferior vena cava compression by pregnant uterus on venous return and epidural plexus

Acronym

Effect of lateral tilt angle on inferior vena cava compression in pregnant women

Scientific Title

The study of inferior vena cava compression by pregnant uterus on venous return and epidural plexus

Scientific Title:Acronym

Effect of lateral tilt angle on inferior vena cava compression in pregnant women

Region

Japan


Condition

Condition

pregnant woman

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Although the left-lateral tilt position following spinal anesthesia is often promoted to reduce compression of the inferior vena by the pregnant uterus, the assumption that this position leads to decreased compression of the inferior vena has not been validated.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in volume of inferior vena cava and aorta

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

MRI measurement

Interventions/Control_2

Tilting position

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

45 years-old >

Gender

Female

Key inclusion criteria

Female

Key exclusion criteria

male

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Ozaki

Organization

Tokyo Woman Medical University

Division name

Department of Anesthesiology

Zip code

1628666

Address

8-1 Kawadacho, Shinjuku

TEL

03-3353-8111

Email

ozaki.makoto@twmu.ac.jp


Public contact

Name of contact person

1st name Hideyuki
Middle name
Last name Higuchi

Organization

Tokyo Woman Medical University

Division name

Department of Anesthesiology

Zip code

1620866

Address

8-1 Kawadacho, Shinjuku

TEL

03-3353-8111

Homepage URL


Email

hhiguchi@twmu.ac.jp


Sponsor or person

Institute

Tokyo Woman Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Woman Medical University

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

Tokyo Woman Medical University

Address

8-1 Kawadacho, Shinjuku, Tokyo

Tel

03-3353-8111

Email

hhiguchi@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 02 Month 14 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

2010 Year 10 Month 01 Day

Date of IRB

2010 Year 08 Month 13 Day

Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date

2018 Year 12 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

2022 Year 09 Month 05 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 13 Day

Last modified on

2022 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013593


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name