UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027757 |
|---|---|
| Receipt number | R000031807 |
| Scientific Title | The study of the association between umbilical pH and blood pressure during cesarean section |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2019/08/27 12:22:07 |
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Basic information
Public title
The study of the association between umbilical pH and blood pressure during cesarean section
Acronym
the association between umbilical pH and blood pressure
Scientific Title
The study of the association between umbilical pH and blood pressure during cesarean section
Scientific Title:Acronym
the association between umbilical pH and blood pressure
Region
| Japan |
Condition
Condition
The patients underwent cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the association between umbilical arterial blood pH.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BP during cesarean section
umbilical artery pH
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
The patients underwent cesarean section in Kyushu University
Key exclusion criteria
Fatal dysfunction
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Hoka |
Organization
Kyushu University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81926425714
shoka@kuaccm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Hukutoku |
Organization
Kyushu University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81926425714
Homepage URL
fukutoku.kana.752@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyushu University IRB
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
+816425714
ijkseimei@jimu.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.med.kyushu-u.ac.jp/kuaccm/
Publication of results
Published
Result
URL related to results and publications
https://home.hiroshima-u.ac.jp/anesth/aar/
Number of participants that the trial has enrolled
400
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Acquired Information]
Age, gender, height, weight and medical history (current medical history, past medical history), electrocardiogram, blood pressure / pulse rate, blood test findings (CBC, leukocyte fraction, blood coagulation data (PT, APTT, platelet count)), Observation (operation time, anesthesia time, bleeding volume, umbilical arterial blood pH, Apgar score), postoperative findings (transfusion volume, bleeding volume, blood coagulation data, CRP, CBC, leukocyte fraction, number of hospital days).
Using the data obtained above, we examine the correlation between maternal blood pressure and umbilical arterial blood pH during caesarean section. We also examine the correlation between Shock Index and umbilical arterial blood pH, Apgar score, hospital stay.
Management information
Registered date
| 2017 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031807
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
