UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035319
Receipt number 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 2023/07/22 08:15:00

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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

Obstetrics 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

Name of lead principal investigator

1st name SHUNSUKE
Middle name
Last name HYUGA

Organization

Kitasato University

Division name

Anesthesiology, School of Medicine

Zip code

2280375

Address

1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa

TEL

042-778-8606

Email

shyuga@kitasato-u.ac.jp


Public contact

Name of contact person

1st name SHUNSUKE
Middle name
Last name HYUGA

Organization

Kitasato University

Division name

Anesthesiology, School of Medicine

Zip code

2280375

Address

1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa

TEL

042-778-8606

Homepage URL


Email

shyuga@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



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

The Kitasato institute clinical research review board

Address

1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa

Tel

042-778-8111

Email

rinri@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(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

https://www.kitasato-u.ac.jp/med/rinri/

Publication of results

Unpublished


Result

URL related to results and publications

Not yet

Number of participants that the trial has enrolled

20

Results

,No postoperative atonic hemorrhage or neuropathy was observed. Table 1 shows patient demographics, final anesthesia level, intraoperative infusion volume, blood loss volume, and urine output. Despite insignificant variances in the lower leg and ankle diameters in the PRE, POST, and 6HR measurements, compression significantly increased between PRE Left,13.6 2.4; Right, 13.4 2.4 and POST Left,,17.4 2.6 Right,16.9 2.6; p0.01 measurements.

Results date posted

2023 Year 07 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We included 18 pregnant women (American Society of Anesthesiologists-Physical status 2) undergoing elective CSs under spinal anesthesia. Subjects with contraindications for spinal anesthesia, chronic medication usage, smoking habits, hypertension, diabetes, thyroid disease, or neuropathic complications were excluded.

Participant flow

All participants were fully informed and provided written consent.

Adverse events

Nothing

Outcome measures

Lower leg and ankle diameters were measured a day before surgery, following which suitably sized elastic stockings were applied.Compression pressure with the stockings were measured at three distinct pointspre-anesthesia PRE, post-surgery POST, and 6 h post-return to the hospital room 6HRusing the Kikuhime pressure monitor TT MediTrade, Soro Denmark. Ankle and lower leg diameters were also measured at the same points. Concurrently, the final level of anesthesia, intraoperative infusion and blood loss volumes, urine output, incidence of postoperative atonic hemorrhage, and presence or absence of neuropathy were also recorded.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 12 Month 28 Day

Date of IRB

2019 Year 01 Month 04 Day

Anticipated trial start date

2019 Year 01 Month 04 Day

Last follow-up date

2020 Year 12 Month 31 Day

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

2023 Year 07 Month 22 Day



Link to view the page

Value
https://center6.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