Unique ID issued by UMIN | UMIN000021034 |
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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 |
Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors
Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors
Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors
Vaginal chloramphenicol transfer to blood in pregnant women and its relationship with maternal and neonatal infant's factors
Japan |
bacterial vaginosis
Obstetrics and Gynecology |
Others
NO
This study aimed to evaluate the plasma concentration in pregnant women treated with vaginal chloramphenicol and its relationship with maternal and her infant factors
Pharmacokinetics
Maternal plasma concentration of chloramphenicol
Factors determining the plasma exposure of chloramphenicol
Effect of maternal plasma concentration of chloramphenicol on her infants
Observational
Not applicable |
Not applicable |
Female
1.Patients receiving trans-vaginal chloramphenicol during pregnancy for bacterial vaginosis
2.Patients receiving written informed consent
1.Patients discontinued trans-vaginal chloramphenicol
2.Patients having severe kidney dysfunction or liver dysfunction
50
1st name | |
Middle name | |
Last name | Junichi Kawakami |
Hamamatsu University School of Medicine
Department of Hospital Pharmacy
1-20-1 Handayama, Hamamatsu 431-3192, Japan
053-435-2762
Pharmacyham-adm@umin.ac.jp
1st name | |
Middle name | |
Last name | Takafumi Naito |
Hamamatsu University School of Medicine
Department of Hospital Pharmacy
1-20-1 Handayama, Hamamatsu 431-3192, Japan
053-435-2623
Pharmacyham-adm@umin.ac.jp
Department of Hospital Pharmacy Hamamatsu University School of Medicine
Department of Hospital Pharmacy Hamamatsu University School of Medicine
Self funding
NO
2016 | Year | 02 | Month | 15 | Day |
Unpublished
Completed
2014 | Year | 02 | Month | 21 | Day |
2014 | Year | 02 | Month | 28 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 02 | Month | 28 | Day |
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
2016 | Year | 02 | Month | 15 | Day |
2017 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024274
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