UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	chiken2@tokuchuhp.jp

Sponsor
Institute	Tokuyama Central Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016611