UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021034
Receipt number R000024274
Scientific Title Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors
Date of disclosure of the study information 2016/02/15
Last modified on 2017/02/14 20:26:58

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Basic information

Public title

Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors

Acronym

Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors

Scientific Title

Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors

Scientific Title:Acronym

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

Obstetrics 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

1st name
Middle name
Last name Junichi Kawakami

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital Pharmacy

Zip code


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

1st name
Middle name
Last name Takafumi Naito

Organization

Hamamatsu University School of Medicine

Division name

Department of Hospital Pharmacy

Zip code


Address

1-20-1 Handayama, Hamamatsu 431-3192, Japan

TEL

053-435-2623

Homepage URL


Email

Pharmacyham-adm@umin.ac.jp


Sponsor or person

Institute

Department of Hospital Pharmacy Hamamatsu University School of Medicine

Institute

Department

Personal name



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)



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

2016 Year 02 Month 15 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 02 Month 21 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024274


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name