Unique ID issued by UMIN | UMIN000035319 |
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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 |
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
Comparison of lower leg compression pressure via elastic stockings before and after spinal anesthesia in pregnant women undergoing cesarean section
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
Comparison of lower leg compression pressure via elastic stockings before and after spinal anesthesia in pregnant women undergoing cesarean section
Japan |
Pregnancy
Obstetrics and Gynecology | Anesthesiology |
Others
NO
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.
Others
The study compares the changes in the pressure on the ankle circumference diameter,circumference of below-knee and lower leg.
Confirmatory
Others
Not applicable
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).
Observational
Not applicable |
Not applicable |
Female
Patients planning a cesarean section via spinal anesthesia, who were approved to participate in the study.
Chronic use of various drugs,smoking,high blood pressure,diabetes,thyroid disease or nerve palsy
20
1st name | SHUNSUKE |
Middle name | |
Last name | HYUGA |
Kitasato University
Anesthesiology, School of Medicine
2280375
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
042-778-8606
shyuga@kitasato-u.ac.jp
1st name | SHUNSUKE |
Middle name | |
Last name | HYUGA |
Kitasato University
Anesthesiology, School of Medicine
2280375
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
042-778-8606
shyuga@kitasato-u.ac.jp
Kitasato University
Kitasato University
Other
The Kitasato institute clinical research review board
1-15-1 Kitasato Minami-ku, Sagamihara City, Kanagawa
042-778-8111
rinri@med.kitasato-u.ac.jp
NO
北里大学病院(神奈川県)
2019 | Year | 01 | Month | 04 | Day |
https://www.kitasato-u.ac.jp/med/rinri/
Unpublished
Not yet
20
,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.
2023 | Year | 07 | Month | 22 | Day |
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.
All participants were fully informed and provided written consent.
Nothing
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.
No longer recruiting
2018 | Year | 12 | Month | 28 | Day |
2019 | Year | 01 | Month | 04 | Day |
2019 | Year | 01 | Month | 04 | Day |
2020 | Year | 12 | Month | 31 | Day |
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.
2018 | Year | 12 | Month | 20 | Day |
2023 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040233
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