UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017414 |
|---|---|
| Receipt number | R000020198 |
| Scientific Title | A study on the monitoring of the fetal state during anesthesia. |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2020/03/15 15:10:33 |
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Basic information
Public title
A study on the monitoring of the fetal state during anesthesia.
Acronym
Fetal electrocardiogram
Scientific Title
A study on the monitoring of the fetal state during anesthesia.
Scientific Title:Acronym
Fetal electrocardiogram
Region
| Japan |
Condition
Condition
Pregnant woman
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effects of fetal state during anesthesia by fetal electrocardiogram.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Spectral analysis of fetal heart rate variability.
2) High-frequency spectral powers
3) Low-frequency spectral powers
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Fetal electrocardiogram
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients undergoing elective cesarean section
Key exclusion criteria
Patients with massive bleeding is expected.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kameyama |
Organization
Tohoku University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1 Seiryoumachi, Aoba-ku, Sendai-shi, Miyagi, Japan
TEL
022-717-7321
y-kameyama@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kameyama |
Organization
Tohoku University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1 Seiryoumachi, Aoba-ku, Sendai-shi, Miyagi, Japan
TEL
022-717-7321
Homepage URL
y-kameyama@umin.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology,Tohoku University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 04 | Day |
Last modified on
| 2020 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020198
