UMIN-CTR Clinical Trial

Basic information
Public title	Effect of left uterine displacement and leg elevation on decrease in maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section; prospective randomized control trial
Acronym	Effect of left uterine displacement and leg elevation on decrease in maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section
Scientific Title	Effect of left uterine displacement and leg elevation on decrease in maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section; prospective randomized control trial
Scientific Title:Acronym	Effect of left uterine displacement and leg elevation on decrease in maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section
Region	Japan

Condition
Condition	Full term pregnancy
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Suppressive effect of left uterine displacement and leg elevation on decrease in maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in maternal cerebral blood flow and oxygenation after spinal anesthesia for cesarean section evaluated by near infrared spectroscopy (NIRS)
Key secondary outcomes

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	4
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Keep the horizontal supine position during 20 min after intrathecal infusion of bupivacaine
Interventions/Control_2	Left uterine displacement by surgical bed rotation during 20 min after intrathecal infusion of bupivacaine
Interventions/Control_3	Leg elevation at an angle of 30 degrees to the horizontal during 20 min after intrathecal infusion of bupivacaine
Interventions/Control_4	Combination of left uterine displacement and leg elevation during 20 min after intrathecal infusion of bupivacaine
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	Healthy full-term pregnant woman aged over 18, undergoing elective cesarean section under spinal anesthesia
Key exclusion criteria	Patient with a diagnosis of hypertension, diabetes and renal dysfunction due to pregnancy, and obese patient whose BMI >30
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuko Kondo
Organization	Nihon University School of Medicine
Division name	Division of Anesthesiology, Department of Anesthesiology
Zip code
Address	30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Nihon University School of Medicin
Division name	Division of Anesthesiology, Department of Anesthesiology
Zip code
Address	30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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	日本大学医学部附属板橋病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 08 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	2013 Year 06 Month 15 Day
Date of IRB	2013 Year 08 Month 09 Day
Anticipated trial start date	2013 Year 07 Month 08 Day
Last follow-up date	2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 07 Month 04 Day
Last modified on	2019 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013025