UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024344 |
|---|---|
| Receipt number | 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 | 2022/05/12 10:36:53 |
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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
| Obstetrics 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
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
left lateral tilt position
Interventions/Control_2
manual uterine left maneuver
Interventions/Control_3
supine position
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 | Tomonori |
| Middle name | |
| Last name | Furuya |
Organization
Department of Anesthesiology, Nihon university school of medicine
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi, Kamimachi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
furuya.tomonori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Furuya |
Organization
Department of Anesthesiology, Nihon university school of medicine
Division name
Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi, Kamimachi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
furuya.tomonori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon university school of medicine
Institute
Department
Personal name
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
Department anesthesiology Nihon University school of medicine
Address
30-1, Itabashi-Ku, Oyaguchi Kamimachi, Tokyo Japan
Tel
0339728111
furuya.tomonori@nihon-u.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
| 2016 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2022 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 06 | Month | 05 | Day |
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
| 2016 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
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
| 2022 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028028
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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