UMIN-CTR Clinical Trial

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	Obsterics 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
Institute	Tokyo Woman Medical University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013593