UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027954 |
|---|---|
| Receipt number | R000032022 |
| Scientific Title | Exploratory observational study using noninvasive circulation monitor on hemodynamics during vaginal delivery |
| Date of disclosure of the study information | 2017/06/27 |
| Last modified on | 2024/04/16 17:51:43 |
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Basic information
Public title
Exploratory observational study using noninvasive circulation monitor on hemodynamics during vaginal delivery
Acronym
Exploratory observational study using noninvasive circulation monitor on hemodynamics during vaginal delivery
Scientific Title
Exploratory observational study using noninvasive circulation monitor on hemodynamics during vaginal delivery
Scientific Title:Acronym
Exploratory observational study using noninvasive circulation monitor on hemodynamics during vaginal delivery
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how the circulatory dynamics change by progression of labor, presence of epidural anesthesia, presence of anger, presence or absence of instrument delivery
Basic objectives2
Others
Basic objectives -Others
Comparison of circulatory dynamics at delivery with or without epidural anesthesia
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Elucidation of circulatory dynamics during delivery
Key secondary outcomes
Elucidation of circulatory dynamics during delivery at the time of epidural anesthesia
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
| Not applicable |
Gender
Female
Key inclusion criteria
nulliparous, normal term delivery, singleton, cephalic presentation, induction of labor
Key exclusion criteria
younger than 20 years old, hypertension induced pregnancy, intra-uterine fetal death, refusal to consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Nagasaka |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
mozaki@anes.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Fukushima |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
rfukushima-twmu@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel
0333538111
ohta.megumi@twmu.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 | 27 | 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
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To collect and analyze data regarding circulation dynamics during labor
Management information
Registered date
| 2017 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032022
