UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042513 |
|---|---|
| Receipt number | R000048529 |
| Scientific Title | A prospective comparative study of the proper placement of the uterine left displacement cushion in pregnant women |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2023/05/24 18:23:15 |
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Basic information
Public title
Examination of the proper position of the lumbar pillow to move the uterus leftward
Acronym
Examination of the proper position of the lumbar pillow to move the uterus leftward
Scientific Title
A prospective comparative study of the proper placement of the uterine left displacement cushion in pregnant women
Scientific Title:Acronym
A prospective comparative study of the proper placement of the uterine left displacement cushion in pregnant women
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine whether the degree of uterine left displacement (the angle of movement to the left of the pelvis) varies with the position of the uterine leftward movement pillow in pregnant women (37 weeks of gestation and beyond).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic tilt (angle) of the pelvis when the uterine left displacement pillow is placed on the hip.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A group in which the lower end of the left uterine displacement pillow (LUD pillow) coincides with the position of the superior anterior iliac spine of the pregnant woman
Interventions/Control_2
A group in which the upper end of the left uterine displacement pillow (LUD pillow) coincides with the position of the superior anterior iliac spine of the pregnant woman
Interventions/Control_3
A group in which the center of the left uterine displacement pillow (LUD pillow) coincides with the position of the superior anterior iliac spine of the pregnant woman
Interventions/Control_4
The group with the bed tilted 15 degrees to the left
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
| 46 | years-old | > |
Gender
Female
Key inclusion criteria
Perturients scheduled for elective cesarean section or vaginal delivery induction and who have given consent to participate in the study
Key exclusion criteria
Chronic use of any drug, smoking, high blood pressure, diabetes, thyroid disease, nerve palsy, significant fetal malformations, if the fetus is dying or complicated by heart disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Okutomi |
Organization
Kitasato university
Division name
Department of anesthesiology, school of medicine
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-Ku,Sagamihara City
TEL
0427788111
tokutomi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | HYUGA |
| Last name | Hyuga |
Organization
Kitasato university
Division name
Department of anesthesiology, school of medicine
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-Ku,Sagamihara City
TEL
0427788111
Homepage URL
s.hyuga.m@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Kitasato institute clinical research review board
Address
1-15-1 Kitasato, Minami-Ku, Sagamihara City
Tel
0427788111
rinrib@med.kitasato-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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.kitasato-u.ac.jp/med/rinri/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.kitasato-u.ac.jp/med/rinri/
Number of participants that the trial has enrolled
38
Results
Results: There were no significant differences in the patient background, blood pressure, or heart rate among the four groups. The degree of pelvic tilt was significantly greater in groups M and L than in groups U and B, and the degree of thoracic tilt was significantly greater in group B than in all other groups.
Results date posted
| 2023 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
After institutional review board approval, informed-consent was obtained from 38 pregnant women after 37 weeks of gestation without hypertension who were admitted for an elective cesarean section or vaginal delivery.
Participant flow
After institutional review board approval, informed-consent was obtained from 38 pregnant women after 37 weeks of gestation without hypertension who were admitted for an elective cesarean section or vaginal delivery.
Adverse events
Nothing
Outcome measures
On a study day, patient was placed in the supine position on a surgical bed, then underwent LUD by either of four methods: the superior anterior iliac spine coincided with the lower edge of a pillow (cylindrical, 35 cm long and 9 cm in diameter) (U), the middle of the pillow (M), or the upper edge of the pillow (L); or (B) tilting the bed 15 degrees to the leftward without pillow placement.
In each method, blood pressure and heart rate were measured, and the degrees of pelvic tilt to the left and thoracic tilt (tilt in the lower third of the sternum) were measured with an angle meter. The U, M, L, and B measurements were statistically compared, compiled, and analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048529
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