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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035319
Receipt No. R000040233
Scientific Title Prospective study on compression pressure of the lower leg via elastic stockings for prevention of deep vein thrombosis in pregnant women undergoing elective cesarean section under spinal anesthesia
Date of disclosure of the study information 2019/01/04
Last modified on 2018/12/20

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Basic information
Public title Prospective study on compression pressure of the lower leg via elastic stockings for prevention of deep vein thrombosis in pregnant women undergoing elective cesarean section under spinal anesthesia
Acronym Comparison of lower leg compression pressure via elastic stockings before and after spinal anesthesia in pregnant women undergoing cesarean section
Scientific Title Prospective study on compression pressure of the lower leg via elastic stockings for prevention of deep vein thrombosis in pregnant women undergoing elective cesarean section under spinal anesthesia
Scientific Title:Acronym Comparison of lower leg compression pressure via elastic stockings before and after spinal anesthesia in pregnant women undergoing cesarean section
Region
Japan

Condition
Condition Pregnancy
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study compares the changes in the pressure on the ankle circumference diameter,circumference of below-knee and lower leg in pregnant women wearing elastic stockings going to a cesarean section under spinal anesthesia.
Basic objectives2 Others
Basic objectives -Others The study compares the changes in the pressure on the ankle circumference diameter,circumference of below-knee and lower leg.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Changes in the pressure (changes during compression and non-compression intervals of intermittent air compression method for the duration after anesthesia) applied on the lower leg due to elastic stockings both before and after spinal anesthesia (0, 6 and 24 hours after returning to her room).
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients planning a cesarean section via spinal anesthesia, who were approved to participate in the study.
Key exclusion criteria Chronic use of various drugs,smoking,high blood pressure,diabetes,thyroid disease or nerve palsy
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name SHUNSUKE HYUGA
Organization Kitasato University
Division name Anesthesiology, School of Medicine
Zip code
Address 1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL 042-778-8606
Email shyuga@kitasato-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name SHUNSUKE HYUGA
Organization Kitasato University
Division name Anesthesiology, School of Medicine
Zip code
Address 1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
TEL 042-778-8606
Homepage URL
Email shyuga@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato 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
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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 04 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Prospective observational study
2.January 2019 - December 2019
3.Recruitment of subjects:Pregnant women who is admitted to our hospital and meet the selection criteria.
4.Measurement items include: the mother's age,body weight,height,BMI,pregnancy week number,pregnancy birth history,past medical history,internal medicines used,puncture site of spinal subarachnoid anesthesia,the degree of disappearance or reduction in the cold sensation,information on the anesthesia record (anesthesia time,operation time,noninvasive blood pressure monitor,percutaneous arterial blood oxygen saturation,electrocardiogram,heart rate,infusion volume,blood transfusion volume,urine volume,bleeding volume),postoperative infusion volume,postoperative urine volume and postoperative bleeding volume.
A pressure sensor is used to measure the pressure applied to the lower leg.

Management information
Registered date
2018 Year 12 Month 20 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040233

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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