UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004816 |
|---|---|
| Receipt number | R000005734 |
| Scientific Title | The measurement of the change of the respiratory tract resistance with the pregnancy |
| Date of disclosure of the study information | 2011/01/04 |
| Last modified on | 2021/07/14 18:16:33 |
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Basic information
Public title
The measurement of the change of the respiratory tract resistance with the pregnancy
Acronym
The respiratory tract resistance measurement of the pregnant woman
Scientific Title
The measurement of the change of the respiratory tract resistance with the pregnancy
Scientific Title:Acronym
The respiratory tract resistance measurement of the pregnant woman
Region
| Japan |
Condition
Condition
pregnant
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we analyze the influence that I measure a change of the respiratory tract resistance with the progress of the pregnancy, and anesthesia at the time of the Caesarean operation gives a breathing function and examine.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A change of the respiratory tract resistance value
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The person that childbirth by the Caesarean operation was planned with the patient who became pregnant
Key exclusion criteria
The person that a Caesarean operation to contribute to mother's bodies such as a person infected with a respiratory system disease, pregnancy high blood pressure was enforced
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kazunori |
| Middle name | |
| Last name | oku |
Organization
Department of Anesthesiology,Showa University School of Medicine
Division name
Department of Anesthesiology,Showa University School of Medicine
Zip code
142-8000
Address
1-5-8hatanodai sinagawaku tokyo
TEL
03-3784-8575
okukazunori@yahoo.co.jp
Public contact
Name of contact person
| 1st name | kazunori |
| Middle name | |
| Last name | oku |
Organization
Department of Anesthesiology,Showa University School of Medicine
Division name
Department of Anesthesiology,Showa University School of Medicine
Zip code
1428000
Address
1-5-8hatanodai sinagawaku tokyo
TEL
0337848575
Homepage URL
okukazunori@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology,Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology,Showa University School of Medicine
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
Showa university
Address
1-5-8hatanodai sinagawaku tokyo
Tel
0337848000
ctsc.admin@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
0191
Org. issuing International ID_1
Showa University Ethical Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
昭和大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jshowaunivsoc/73/2/73_129/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jshowaunivsoc/73/2/73_129/_article/-char/ja/
Number of participants that the trial has enrolled
35
Results
R5, R20, Z5 and the resonance coefficient increased as the pregnancy progressed, but the changes were strong after 30 weeks, and the changes in R5, R20 and Z5 correlated with the amount of weight gain. It was suggested that the change in lung function associated with pregnancy was strong after 30 weeks, and that the degree of change was affected by weight gain.
Results date posted
| 2021 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2013 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
The subjects were 35 cases scheduled for cesarean section at Showa University Hospital and Showa University Fujigaoka Hospital. The measurement period was from 17 to 37 weeks of gestation, and IOS was measured every 4 weeks.
Participant flow
The subjects were 35 cases scheduled for cesarean section at Showa University Hospital and Showa University Fujigaoka Hospital. The measurement period was from 17 to 37 weeks of gestation, and IOS was measured every 4 weeks.
Adverse events
non
Outcome measures
R5-R20 was calculated by measuring the respiratory resistance R5 and R20, impedance (Z5), reactance (X5), resonance coefficient, etc. when 5Hz and 20Hz impulses were applied using IOS in the sitting position.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
We observe it about a thing planned childbirth by a Caesarean operation
Management information
Registered date
| 2011 | Year | 01 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005734
