UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	okukazunori@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology,Showa University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005734