UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors
Title of the study (Brief title)	Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors
Region	Japan

Condition
Condition	bacterial vaginosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the plasma concentration in pregnant women treated with vaginal chloramphenicol and its relationship with maternal and her infant factors
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maternal plasma concentration of chloramphenicol
Key secondary outcomes	Factors determining the plasma exposure of chloramphenicol Effect of maternal plasma concentration of chloramphenicol on her infants

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1.Patients receiving trans-vaginal chloramphenicol during pregnancy for bacterial vaginosis 2.Patients receiving written informed consent
Key exclusion criteria	1.Patients discontinued trans-vaginal chloramphenicol 2.Patients having severe kidney dysfunction or liver dysfunction
Target sample size	50

Research contact person
Name of lead principal investigator	Junichi Kawakami
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital Pharmacy
Address	1-20-1 Handayama, Hamamatsu 431-3192, Japan
TEL	053-435-2762
Email	Pharmacyham-adm@umin.ac.jp

Public contact
Name of contact person	Takafumi Naito
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital Pharmacy
Address	1-20-1 Handayama, Hamamatsu 431-3192, Japan
TEL	053-435-2623
Homepage URL
Email	Pharmacyham-adm@umin.ac.jp

Sponsor
Institute	Department of Hospital Pharmacy Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Hospital Pharmacy Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 02 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 21 Day
Anticipated trial start date	2014 Year 02 Month 28 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: Cohort study Object recruitment: Patients receiving trans-vaginal chloramphenicol during pregnancy for bacterial vaginosis from April 2014 to March 2017 Primary outcome: Maternal plasma concentration of chloramphenicol Secondary outcome: Factors determining the plasma exposure of chloramphenicol such as hepatic and urine function Effect of maternal plasma concentration of chloramphenicol on her infants

Management information
Registered date	2016 Year 02 Month 15 Day
Last modified on	2017 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024274