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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024344
Receipt No. R000028028
Scientific Title Effect of left lateral tilt position and manual displacement of the uterus for the pregnant woman
Date of disclosure of the study information 2016/10/10
Last modified on 2017/04/29

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Basic information
Public title Effect of left lateral tilt position and manual displacement of the uterus for the pregnant woman
Acronym Effect of left lateral tilt position and manual displacement of the uterus for the pregnant woman : observational clinical study
Scientific Title Effect of left lateral tilt position and manual displacement of the uterus for the pregnant woman
Scientific Title:Acronym Effect of left lateral tilt position and manual displacement of the uterus for the pregnant woman : observational clinical study
Region
Japan

Condition
Condition pregnancy
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study determined the difference of effect for inferior vena cava (IVC) diameter between left lateral tilt posion and manual displacement of the gravida uterus under real time visualization with ultrasonography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Maximum and minimum IVC diameter in supine, left lateral tilt posion and manual displacement
Key secondary outcomes

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
40 years-old >=
Gender Female
Key inclusion criteria The body mass index (kg/m2) is ranged 20 from under 30.
Written, informed consent have to be obtained after sufficient explanation.
Key exclusion criteria The case of development of the symptom due to aortocaval compression or supne hypotention syndrome in supine position.
Preeclampsia
pregnancy induced hypertension.
Gestational diabetes mellitus.
The case of labouring.
Cardiac and vasucular anomaly.
Asthma.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Furuya
Organization Department of Anesthesiology, Nihon university school of medicine
Division name Anesthesiology
Zip code
Address 30-1 Oyaguchi, Kamimachi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email furuya.tomonori@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TomonoriFuruya
Organization Department of Anesthesiology, Nihon university school of medicine
Division name Anesthesiology
Zip code
Address 30-1 Oyaguchi, Kamimachi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email furuya.tomonori@nihon-u.ac.jp

Sponsor
Institute Nihon university school of medicine
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 10 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
No patients retired by reason of appearance of SHS and hemodynamic collapse in any position.
Both LLT positioning and LUD enlarge IVCD max compared to supine without influence to maternal hemodynamics. There were no significant statistical difference between two maneuver. Neither LLT positioning nor LUD influenced IVCD min and CI significant change compared to supine. There were no significant differences observed in maternal hemodynamics in three different conditions.


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
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We mesuared blood pressure, heart rate and arterial oxygen saturation in supine, left lateral tilt position and manual displacement of the uterus as secondary end point.

Management information
Registered date
2016 Year 10 Month 08 Day
Last modified on
2017 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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