UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014262 |
|---|---|
| Receipt number | R000016611 |
| Scientific Title | Investigation of dexmedetomidine concentration in breast milk during postpartum period |
| Date of disclosure of the study information | 2014/06/13 |
| Last modified on | 2021/04/19 09:05:12 |
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Basic information
Public title
Investigation of dexmedetomidine concentration in breast milk during postpartum period
Acronym
Investigation of dexmedetomidine concentration in breast milk during postpartum period
Scientific Title
Investigation of dexmedetomidine concentration in breast milk during postpartum period
Scientific Title:Acronym
Investigation of dexmedetomidine concentration in breast milk during postpartum period
Region
| Japan |
Condition
Condition
pregnant women undergo elective cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the transfer of dexmedetomidine into breast milk after cesarean section
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
dexmedetomidine concentration in breast milk
Key secondary outcomes
dexmedetomidine concentration in blood
neonatal assessment
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
regulatory administration of dexmedetomidine after delivery for cesarean section
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
normal pregnant women undergo elective cesarean section
Key exclusion criteria
patientrefusal
serious preexisting condition
massive bleeding
unexpected vital change
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Tokuyama Central hospital
Division name
department of anesthesiology
Zip code
Address
1-1 kodacyo, Shunan 745-8522, Japan
TEL
0834-28-4411
manabu-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Tokuyama Central Hospital
Division name
department of anesthesiology
Zip code
Address
1-1 Kodacyo, Shunan 745-8522, Japan
TEL
0834-28-4411
Homepage URL
chiken2@tokuchuhp.jp
Sponsor or person
Institute
Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokuyama Central Hospital
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
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
| 2014 | Year | 06 | Month | 13 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 13 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 13 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 16 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016611
